Information Brochure

Satrishi Institute of Clinical ResearchWe build Corporate Skills

Education amp Training Programs to Facilitate Career in Clinical Research amp Continuous Clinical Research Professional Services

Clinical Research ndashAn outlineClinical research is an integral part of the drug discovery process to ensure the safety and efficacy of any new drug In todayrsquos global scientific era clinical trials are the mainstay for bringing newer and better drugs to market Although a set of robust guidelines and regulations are in place to govern the conduct of clinical trials in any country the conduct of clinical research is also looked upon as an area of humanitarian concern

Discovering and bringing one new drug to the public typically costs a pharmaceutical or biotechnology company nearly $900 million to $1 billion and takes an average of 10 to 12 years It is designed to ensure that only those pharmaceutical products that are both safe and effective are brought to market

New drugs begin in the laboratory with scientists including chemists and pharmacologists who identify cellular and genetic factors that play a role in specific diseases Out of every 5000 new compounds identified during the discovery process only five are considered safe for testing in human volunteers after preclinical evaluations After three to six years of further clinical testing in patients only one of these compounds is ultimately approved as a marketed drug for treatment

India ndash Integral Part of Global Clinical Research IndustryIndia has moved from a position of a Rescue Country to a Strategic Country in the last 10 years This cannot bull happen by trial and errorIndian pharmaceutical industry is estimated to be around $2 billion by 2010 (Mc Kinsey Report-ldquoThe global Clinical bull trial outsourcing opportunityrdquoDemand for more than 10000 investigators trained in Good Clinical Practice (GCP) and 50000 clinical research bull professionals (Mc Kinsey Report-ldquoThe global Clinical trial outsourcing opportunityrdquo)The clinical trial outsourced market in India is forecasted to grow at a CAGR of around 31 during 2010-2012 bull (Booming Clinical Trials Market in India-RNCOS September 2009)Domestic Pharma market is likely to touch $20 billion by 2015 making India a lucrative destination for clinical bull trials for global giants (FICCI-Ernst amp Young Report on Compelling Reasons for Doing Clinical Research in India-2009)The amendments to Indiarsquos patent legislation with the advent of ldquoproduct patentsrdquo mdash the visible outcome of India bull becoming a signatory to the World Trade Organizationrsquos agreement on Trade- Related Aspects of Intellectual Property RightsPatent products may capture 8-10 share of the total market by 2015 (FICCI-Ernst amp Young Report)bull The number of industry-sponsored Phase II-III sites in India has grown by 116 over the last 15 months and India bull has moved from rank 18 to 12 across the 60 most active countries (FICCI-Ernst amp Young Report)India ranks second in Asia after Japan in its number of industry-sponsored Phase II-III Clinical trial study sitesbull India worldrsquos Second-largest producer of drugs by volume with the third-largest drug research and development bull workforce India is a major player in the pharmaceutical industryIndia has one of the fastest subject recruitment rates globally (nearly three to five times the global average) with bull screen failure and dropout rates lower by nearly 40ndash50 as compared to global averagesIndia is ranked third across all countries after the USA and China in terms of its overall attractiveness as a clinical bull trial destination according to AT Kearney global surveyClinical trials in the country are conducted as per the lsquoEthical Guidelines for Biomedical Research on Human bull Participantsrsquo issued by the Indian Council of Medical Research 2006A revision of Schedule Y of the Drugs and Cosmetics Rules which allowed simultaneous conduct of Phase bull II and III studiesIndia has more than 2299 industry-sponsored Phase II-III clinical trial study sites that are carrying out bull clinical trial activity across the top 15 cities in the countryThere are ~1500 investigators with the investigator base growing at gt40 per year faster than any other bull emerging markets

Nine of the top fifteen global pharmaceutical and biotech companies have set up captive clinical research centers in bull the country Viz Pfizer Bayer GlaxoSmithKline Johnson amp Johnson Sanofi- Aventis AstraZeneca Merck amp Co Abbott Laboratories Wyeth Bristol-Myers Squibb Eli Lilly and CompanySeven of the top Nine global CROs have an established India presence Like Quintiles Covance PPD ICON bull Parexel MDS Kendle PharmaNet Development and PRA InternationalWhile the number of studies is comparable with most emerging markets the mean patient enrolment rates in India bull are higher by nearly 15- 20 as compared to other emerging economiesOver 60 CROs offer Phase I to IV trials complying with ICH-GCP guidelinesbull India has some of the top medicalscientific universities in Asiabull Sophisticated technological infrastructure 100 million plus English speaking people (Largest outside US)bull Over 2 million science post graduates and increasingbull Large pool of treatment naiumlve patients from multiethnic and multiracial backgroundsbull Cost effective operationsbull Higher GMPGLPGCP Compliancebull Maximum number of approved GMP plants outside USAbull Excellent quality management technology and infrastructurebull Strong IT industry amp availability of IT skilled manpowerbull USFDA has set up office in India ndash this shows Indiarsquos importance in the global clinical research and Pharma spacebull ICMRrsquos National Institute of Medical Statistics (NIMS) has set up the Clinical Trials Registry- India (CTRI) for bull registration of all clinical trials conducted in the country

Why Career in Clinical Researchbull Fastest growing segment in the healthcare pharmaceutical industry globallybull Excellent Opportunity to Develop Combination of Technical and Management Skill Developmentbull Part of the Global Growth Opportunitybull Wider Job Horizonbull Rapidly Growing Opportunitieshellip and growing (internal and external)bull Attractive Compensation and future growthbull Higher Job Satisfactionbull Continuous Training Opportunitiesbull International Working and Training Opportunitiesbull Huge Demand amp Supply Gap Easy Entrybull Good Career Prospectsbull Quickies (quick money growth on the ladder)bull Understanding of Drugs Diseases amp Management

Clinical Research Career - Are you EligibleClinical Research has created several thousand new job opportunities in India from in the last few years and it has showed its reflection in Indian Economy too More new job opportunities would be created in the coming years Clinical Research opened a wide range of manpower requirement in different fields like Clinical Research as core and specialized fields like Pharmacovigilance Regulatory Affairs Quality Assurance Auditing amp Inspection Medical Writing Biostatistics Clinical Data Management BABE Studies Bio Analytics Medical Device trials and some opportunities in non core areas like language translation services logistic services etc

A nation with more than 1 billion people India has the second largest population in the world India is being recognized as potential geography to conduct global trials since India became a member of the World Trade Organization (WTO) in 1995 and agreed to adhere to the product patent regime by 2005 As a result the global pharmaceutical industry has the rights to patent products as well as processes throughout the world including India This has led to a significant growth of the pharmaceutical industry both domestically in India and globally including increased stakes of multinational companies in Indian operations

As mentioned above there are several job opportunities for the graduates and post graduates in Medical Dental Homeopathic Ayurvedic Physiotherapy Pharmacy Life Sciences Biochemistry Microbiology Science and Mathematics Students However selecting a suitable job function according to your academic qualification experience and interest is crucial and this may require clear understanding of the job profile

Career PathwaysPharmaceutical Biotech CompaniesThe pharmaceuticalBiotech company develops produces and markets drugs licensed for use as medications Pharmaceutical companies can deal in generic andor brand medications They are subject to a variety of laws and regulations regarding the patenting testing and marketing of drugsEg Aventis Pharma Limited Biocon Cadila Healthcare Limited Cipla Limited Dr Reddys Laboratories Glaxo SmithKline Pharmaceuticals Limited Wockhardt Limited JB Chemicals Serum Institute of India Ranbaxy Laboratories Nicholas Piramal Pfizer Ranbaxy Elli Lilly etc

Clinical CROs (Contract Research Organizations)A Contract Research Organization also called a Clinical Research Organization (CRO) is a service organization that provides support to the pharmaceutical and biotechnology industries CROs offer clients a wide range of outsourced pharmaceutical research services to aid in the drug and medical device research and development processEg Covance Parexel Chiltern PRA International MDS Lambda Quintiles GVK PPD Reliance Life Sciences KPS Clinical Services Pvt Ltd etc

BABE CentersConduct Bio Availability amp Bio equivalence studies The BABE studies are performed for generic drugs new drug delivery systems and new chemical entitiesEg Synchron Lambda Therapeutics Lotus Lab Vimta Lab Wellquest Jubilant LG Life Science etc

SMOSite Management Organizations are responsible for managing clinical trial investigational site by providing required assistance staffs and other requirementsEg Neeman Medical Odyssey Research Accunova SMO India Excell Life Sciences etc

Data Management CROsClinical Data Management CROs assist in data entry data tracking amp reporting CRF creation amp design database reporting amp testing medical coding amp review and adverse event reportingEg Quintiles Synchron Cognizant SIRO Accenture DnO ClinInvent TCS IBM HCL etc

Medical Writing CompaniesMedical Writing company will creates documents that effectively and clearly describe research results product use and other medical information working with doctors scientists and other subject matter experts The medical writer also makes sure the documents comply with regulatory journal or other guidelines in terms of content format and structureEg Promed Kinapse MMS Holdings Laxai Avanti GVK Green Technologies Makro Care etc

EDC Service ProvidersIn India now clinical trials exposed to advanced technologies like electronic data capture for the ease and accurate data capture from the investigational sitesEg Quintiles Reliance communication limited Bio Clinica etc

Central LaboratoriesCentral laboratories are indispensible part of clinical trials as it is requires regular basis of laboratory specimen analysis profiling etc In clinical trials the importance of central laboratories are high compare to basic clinical laboratory testing as clinical trial requires uniformity in testing of sample all across the sitesEg ACM Global Central lab BAAP Diagnostics Ltd Diagnosearch Intervein Laboratories PvtLtd Lambda Therapeutic Research Medpace Metropolis Health Service Piramal Diagnostic Services

HospitalsClinics -Investigator amp Site StaffIn clinical trial language hospitalsclinics are usually known as investigational Site Investigators normally doctors by profession who conduct clinical trial according to the protocol provided by the sponsor and other rules and regulations Apart from the investigators a clinical trial site required minimum number of staffs to coordinate clinical trial activities in the siteEg AIIMS MAX Hospitals Escorts Fortis Medicity PGIMER Chandigarh etc

Training CentresAs clinical trial exponentially grew in India and It also calls for the training necessity for the better work culture and maintain the ethics of clinical trials in India Training centers are playing a crucial role in creating good professionals in clinical research conduct area and it requires continuous training for the experienced professional also towards the new trends and advancements

Job Opportunities for the Next Four YearsPosition Approx Number

Clinical Research Associate (CRA) Clinical Monitor 7000

Clinical research Coordinator (CRC) Site Coordinator 20000

Drug Safety Personnel 3000

Investigator 12000

Project Personnel 2000

Medical Monitor 3000

Regulatory Affairs Personnel 3000

Medical Writer 1000

Quality Control Assurance Personnel 2000

Data Management Personnel 7000

Bio Statistician 500

Research Scientist 2000

Lab Personnel 1500

Management amp Administrative Personnel 2000

WHY SATRISHI INSTITUTE OF CLINICAL RESEARCH (SICR)SICR is a premier training amp research institute in Clinical Research campaigns by RAHE Group of Organization in bull the auspicious of the KPS Clinical Services Pvt Ltd (An Indian Based CRO)SICR was established in 2008 to provide Quality of Education to clinical research profession aspirants amp encouraged bull by the response in graduate coursesSICR is the only Institute in the entire India which is involved in total spectrum of practical training with help of bull Team of KPS Clinical ServicesSICR will be a leading Clinical Research training provider by delivering compelling appraises suggestion and quality bull education in Clinical Research to every individual irrespective of caste creed social or religious background

and to make them world class professionalsbull SICR will provide clinical research practical oriented training through passion of Christ for excellence and bull unbendable commitment

ABOUT KPS CLINICAL SERVICES PVT LTDKPS Clinical Services is a Contract Research Organization (CRO) providing variety of services for clinical trials bull and pharmaceutical regulatory affairs in IndiaKPS Clinical Services (KPSCS) is a pioneer in the concept to develop a way to ease suffering to enhance the quality bull of life and to overcome the hurdles in clinical research It is aimed at providing world-class clinical research services to pharmaceutical biotechnology medical device companies academic and government organizationsKPSCS believes in applying innovative technologies amp therapeutic expertise with a commitment to quality to bull enhance quality of life amp to help our clients amp partners in maximizing their returns on investment and accelerate the delivery of safe and effective therapeutics to patientsKPSCS offers a training program in clinical research that is Professional Diploma in Clinical Trial Management bull running under RAHE-Group of organizations for recent graduates in pharmaceutical science medical science dental science and life sciences who are interested in pursuing a career in clinical researchKPSCS is Indiarsquos one of the best training center offers High Quality Professional Training Programs in Clinical bull Research through Classroom Weekend Classes and distance learning programsGood Clinical Practice (GCP) guidelines and regulations like Schedule Y USFDA CFR Part 21 EMEA MHRA bull govern clinical trials and a thorough knowledge of guidelines and regulations at every stage of the clinical trial process is essential KPSCS helps the students and working professionals in achieving the level of expertise required through its high quality comprehensive user friendly and cost effective training programs ndash whether you need to train for a career in clinical trials update your knowledge with current information or equip with the new skills in this areaClinical Research and its allied fields today offers most attractive and innovative career opportunities to the bull graduates and post graduates in India and Abroad(MD MBBS BDS BAMS BHMS BUMS BPT Biochemistry Biotechnology Microbiology Pharmacy Pharmacology Life Sciences and other allied life sciences streams)We at KPS Clinical Services Pvt Ltd are committed towards developing India as a hub for global clinical research bull by catering to the ever-growing training and compliance needs of the profession through specialized training courses and workshops pharmaceutical companies Hospitals contract research organizations (CROs) research amp academic institutions etc as job prospects

TrainingObjective(s)

1 To provide an in-depth knowledge amp opportunity for skills development in Clinical research2 To nurture the culture of 100 clinical research-Competency development

Target audience Specialization in clinical research professionals employed in pharmaceutical companies Hospitals contract research organizations (CROs) research amp academic institutions etc as job prospects

Mukesh Kumar MPharm (Clinical Pharmacy) CPSR (USA) Director-Clinical Operation amp QA KPS Clinical Services Pvt Ltd Having more than 6 years clinical research experience as Clinical Research Coordinator Clinical Research Associate and Project Manager in various oncology trials (sponsored by Govt of India) across various Indian hospitalsbull Editor-in chief The Clinical Research Plus(TCRP) Magazinebull Vice President of IYPA (Indian Youth Pharmaceutical Association)bull Awarded certificate of FDA Med Watch and patient safety from US FDAbull Awarded certificate for membership of ISCR (Indian Society of Clinical Research)bull Executive Member of scrutiny council Clinical Research Board Indiabull Member of IPGA Indiabull Member Advisory Board Mytech professional

Industry SpeaksldquoIn the Clinical Research industry the need of the hour is professionals with the right balance of Clinical Research Education and Management knowledge SICR with its focus on management curriculum creates professionals who are ready to play the role the industry demandsrdquo

Dr Sanjeev Investigator Novartis UK

ldquoAs the Clinical Research industry grows there is a greater requirement for professionals who need to uphold the safety and ethical standards in clinical trials SICR with its commitment to provide ethical education can meet the industry expectationsrdquo

Dr MMirManager-QA Fortis clinical services Pvt Ltd

ldquoTime is an important factor during clinical trials There is a requirement for professionals who can quickly learn the operations and functions without any time-consuming training The industry-endorsed curriculum and training at SICR ensures students emerging out of SICR are thoroughly prepared for the challenges aheadrdquo

Dr TanvirProfessor- Department of Pharmacy- AMITY University

CLINICAL RESEARCH PROGRAMS OFFERED BY SICR

SNo Course Duration Fees

1 Post Graduate Diploma in ClinicalResearch (PGDCR)

1 Year(Regular Course) 98000-

2 Post Graduate Diploma in ClinicalData Management (PGDCDM)

1 Year(Regular Course) 158800-

3 Professional Diploma in ClinicalTrial Management (PDCTM)

6 Months(Distance Learning)

8600- (For Indian Students)

US$ 300 (For Abroad Students)

4 Professional Diploma inPharmacovigilance (PDPhV)

6 Months(Distance Learning)

8800- (For Indian Students)

US$ 350 (For Abroad Students)

5 Professional Diploma in DrugRegulatory Affairs (PDDRA)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

6Professional Diploma in

Intellectual Property Right(PDIPR)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

7Professional Diploma in Clinical

Pharmacy Management(PDCPM)

6 Months(Distance Learning)

7500- (For Indian Students)

US$ 295 (For Abroad Students)

8Professional Diploma in Hospital

Pharmacy Management(PDHPM)

6 Months(Distance Learning)

6400- (For Indian Students)

US$ 255 (For Abroad Students)

(The Clinical Research Plus (Indiarsquos First Clinical Research Magazine)wwwtcrpin

Satrishi Institute of Clinical ResearchF-215216 II Floor Neelkanth Plaza Alpha Commercial BeltAlpha I Greater Noida GB Nagar (UP) INDIA ndash 201306Ph 0120-423172021 Fax 0120-4213840 M 08750047473

Email- infosicrin Website- wwwsicrin

Specialty In the visual appearance of

CLINICAL ACADEMIC TRAININGbull 1048766 GCP Guideline workshop 1048766 Site Selection amp Management workshop 1048766 Industry Training Certificate in Clinical Research

CLINICAL SERVICESbull CLINICAL TRIAL EXECUTION Phase I Clinical Trials Phase II-IV Clinical Trials bull Project Management bull Clinical Trial Monitoring bull Clinical Trial Site management 1048766 REGULATORY AFFAIRS 1048766 QUALITY ASSURANCE (QA) 1048766 MEDICAL WRITING AND TRANSLATION bull Protocol Design bull Essential Clinical Trial Documents 1048766 POST-MARKETING SURVEILLANCE 1048766 TDM amp DATA MANAGEMENT

KPS Clinical Services Pvt LtdA Contract Research Organization

Clinical Research

Education amp Training Programs to Facilitate Career in Clinical Research amp Continuous Clinical Research Professional Services

Clinical Research ndashAn outlineClinical research is an integral part of the drug discovery process to ensure the safety and efficacy of any new drug In todayrsquos global scientific era clinical trials are the mainstay for bringing newer and better drugs to market Although a set of robust guidelines and regulations are in place to govern the conduct of clinical trials in any country the conduct of clinical research is also looked upon as an area of humanitarian concern

Discovering and bringing one new drug to the public typically costs a pharmaceutical or biotechnology company nearly $900 million to $1 billion and takes an average of 10 to 12 years It is designed to ensure that only those pharmaceutical products that are both safe and effective are brought to market

New drugs begin in the laboratory with scientists including chemists and pharmacologists who identify cellular and genetic factors that play a role in specific diseases Out of every 5000 new compounds identified during the discovery process only five are considered safe for testing in human volunteers after preclinical evaluations After three to six years of further clinical testing in patients only one of these compounds is ultimately approved as a marketed drug for treatment

India ndash Integral Part of Global Clinical Research IndustryIndia has moved from a position of a Rescue Country to a Strategic Country in the last 10 years This cannot bull happen by trial and errorIndian pharmaceutical industry is estimated to be around $2 billion by 2010 (Mc Kinsey Report-ldquoThe global Clinical bull trial outsourcing opportunityrdquoDemand for more than 10000 investigators trained in Good Clinical Practice (GCP) and 50000 clinical research bull professionals (Mc Kinsey Report-ldquoThe global Clinical trial outsourcing opportunityrdquo)The clinical trial outsourced market in India is forecasted to grow at a CAGR of around 31 during 2010-2012 bull (Booming Clinical Trials Market in India-RNCOS September 2009)Domestic Pharma market is likely to touch $20 billion by 2015 making India a lucrative destination for clinical bull trials for global giants (FICCI-Ernst amp Young Report on Compelling Reasons for Doing Clinical Research in India-2009)The amendments to Indiarsquos patent legislation with the advent of ldquoproduct patentsrdquo mdash the visible outcome of India bull becoming a signatory to the World Trade Organizationrsquos agreement on Trade- Related Aspects of Intellectual Property RightsPatent products may capture 8-10 share of the total market by 2015 (FICCI-Ernst amp Young Report)bull The number of industry-sponsored Phase II-III sites in India has grown by 116 over the last 15 months and India bull has moved from rank 18 to 12 across the 60 most active countries (FICCI-Ernst amp Young Report)India ranks second in Asia after Japan in its number of industry-sponsored Phase II-III Clinical trial study sitesbull India worldrsquos Second-largest producer of drugs by volume with the third-largest drug research and development bull workforce India is a major player in the pharmaceutical industryIndia has one of the fastest subject recruitment rates globally (nearly three to five times the global average) with bull screen failure and dropout rates lower by nearly 40ndash50 as compared to global averagesIndia is ranked third across all countries after the USA and China in terms of its overall attractiveness as a clinical bull trial destination according to AT Kearney global surveyClinical trials in the country are conducted as per the lsquoEthical Guidelines for Biomedical Research on Human bull Participantsrsquo issued by the Indian Council of Medical Research 2006A revision of Schedule Y of the Drugs and Cosmetics Rules which allowed simultaneous conduct of Phase bull II and III studiesIndia has more than 2299 industry-sponsored Phase II-III clinical trial study sites that are carrying out bull clinical trial activity across the top 15 cities in the countryThere are ~1500 investigators with the investigator base growing at gt40 per year faster than any other bull emerging markets

Nine of the top fifteen global pharmaceutical and biotech companies have set up captive clinical research centers in bull the country Viz Pfizer Bayer GlaxoSmithKline Johnson amp Johnson Sanofi- Aventis AstraZeneca Merck amp Co Abbott Laboratories Wyeth Bristol-Myers Squibb Eli Lilly and CompanySeven of the top Nine global CROs have an established India presence Like Quintiles Covance PPD ICON bull Parexel MDS Kendle PharmaNet Development and PRA InternationalWhile the number of studies is comparable with most emerging markets the mean patient enrolment rates in India bull are higher by nearly 15- 20 as compared to other emerging economiesOver 60 CROs offer Phase I to IV trials complying with ICH-GCP guidelinesbull India has some of the top medicalscientific universities in Asiabull Sophisticated technological infrastructure 100 million plus English speaking people (Largest outside US)bull Over 2 million science post graduates and increasingbull Large pool of treatment naiumlve patients from multiethnic and multiracial backgroundsbull Cost effective operationsbull Higher GMPGLPGCP Compliancebull Maximum number of approved GMP plants outside USAbull Excellent quality management technology and infrastructurebull Strong IT industry amp availability of IT skilled manpowerbull USFDA has set up office in India ndash this shows Indiarsquos importance in the global clinical research and Pharma spacebull ICMRrsquos National Institute of Medical Statistics (NIMS) has set up the Clinical Trials Registry- India (CTRI) for bull registration of all clinical trials conducted in the country

Why Career in Clinical Researchbull Fastest growing segment in the healthcare pharmaceutical industry globallybull Excellent Opportunity to Develop Combination of Technical and Management Skill Developmentbull Part of the Global Growth Opportunitybull Wider Job Horizonbull Rapidly Growing Opportunitieshellip and growing (internal and external)bull Attractive Compensation and future growthbull Higher Job Satisfactionbull Continuous Training Opportunitiesbull International Working and Training Opportunitiesbull Huge Demand amp Supply Gap Easy Entrybull Good Career Prospectsbull Quickies (quick money growth on the ladder)bull Understanding of Drugs Diseases amp Management

Clinical Research Career - Are you EligibleClinical Research has created several thousand new job opportunities in India from in the last few years and it has showed its reflection in Indian Economy too More new job opportunities would be created in the coming years Clinical Research opened a wide range of manpower requirement in different fields like Clinical Research as core and specialized fields like Pharmacovigilance Regulatory Affairs Quality Assurance Auditing amp Inspection Medical Writing Biostatistics Clinical Data Management BABE Studies Bio Analytics Medical Device trials and some opportunities in non core areas like language translation services logistic services etc

A nation with more than 1 billion people India has the second largest population in the world India is being recognized as potential geography to conduct global trials since India became a member of the World Trade Organization (WTO) in 1995 and agreed to adhere to the product patent regime by 2005 As a result the global pharmaceutical industry has the rights to patent products as well as processes throughout the world including India This has led to a significant growth of the pharmaceutical industry both domestically in India and globally including increased stakes of multinational companies in Indian operations

As mentioned above there are several job opportunities for the graduates and post graduates in Medical Dental Homeopathic Ayurvedic Physiotherapy Pharmacy Life Sciences Biochemistry Microbiology Science and Mathematics Students However selecting a suitable job function according to your academic qualification experience and interest is crucial and this may require clear understanding of the job profile

Career PathwaysPharmaceutical Biotech CompaniesThe pharmaceuticalBiotech company develops produces and markets drugs licensed for use as medications Pharmaceutical companies can deal in generic andor brand medications They are subject to a variety of laws and regulations regarding the patenting testing and marketing of drugsEg Aventis Pharma Limited Biocon Cadila Healthcare Limited Cipla Limited Dr Reddys Laboratories Glaxo SmithKline Pharmaceuticals Limited Wockhardt Limited JB Chemicals Serum Institute of India Ranbaxy Laboratories Nicholas Piramal Pfizer Ranbaxy Elli Lilly etc

Clinical CROs (Contract Research Organizations)A Contract Research Organization also called a Clinical Research Organization (CRO) is a service organization that provides support to the pharmaceutical and biotechnology industries CROs offer clients a wide range of outsourced pharmaceutical research services to aid in the drug and medical device research and development processEg Covance Parexel Chiltern PRA International MDS Lambda Quintiles GVK PPD Reliance Life Sciences KPS Clinical Services Pvt Ltd etc

BABE CentersConduct Bio Availability amp Bio equivalence studies The BABE studies are performed for generic drugs new drug delivery systems and new chemical entitiesEg Synchron Lambda Therapeutics Lotus Lab Vimta Lab Wellquest Jubilant LG Life Science etc

SMOSite Management Organizations are responsible for managing clinical trial investigational site by providing required assistance staffs and other requirementsEg Neeman Medical Odyssey Research Accunova SMO India Excell Life Sciences etc

Data Management CROsClinical Data Management CROs assist in data entry data tracking amp reporting CRF creation amp design database reporting amp testing medical coding amp review and adverse event reportingEg Quintiles Synchron Cognizant SIRO Accenture DnO ClinInvent TCS IBM HCL etc

Medical Writing CompaniesMedical Writing company will creates documents that effectively and clearly describe research results product use and other medical information working with doctors scientists and other subject matter experts The medical writer also makes sure the documents comply with regulatory journal or other guidelines in terms of content format and structureEg Promed Kinapse MMS Holdings Laxai Avanti GVK Green Technologies Makro Care etc

EDC Service ProvidersIn India now clinical trials exposed to advanced technologies like electronic data capture for the ease and accurate data capture from the investigational sitesEg Quintiles Reliance communication limited Bio Clinica etc

Central LaboratoriesCentral laboratories are indispensible part of clinical trials as it is requires regular basis of laboratory specimen analysis profiling etc In clinical trials the importance of central laboratories are high compare to basic clinical laboratory testing as clinical trial requires uniformity in testing of sample all across the sitesEg ACM Global Central lab BAAP Diagnostics Ltd Diagnosearch Intervein Laboratories PvtLtd Lambda Therapeutic Research Medpace Metropolis Health Service Piramal Diagnostic Services

HospitalsClinics -Investigator amp Site StaffIn clinical trial language hospitalsclinics are usually known as investigational Site Investigators normally doctors by profession who conduct clinical trial according to the protocol provided by the sponsor and other rules and regulations Apart from the investigators a clinical trial site required minimum number of staffs to coordinate clinical trial activities in the siteEg AIIMS MAX Hospitals Escorts Fortis Medicity PGIMER Chandigarh etc

Training CentresAs clinical trial exponentially grew in India and It also calls for the training necessity for the better work culture and maintain the ethics of clinical trials in India Training centers are playing a crucial role in creating good professionals in clinical research conduct area and it requires continuous training for the experienced professional also towards the new trends and advancements

Job Opportunities for the Next Four YearsPosition Approx Number

Clinical Research Associate (CRA) Clinical Monitor 7000

Clinical research Coordinator (CRC) Site Coordinator 20000

Drug Safety Personnel 3000

Investigator 12000

Project Personnel 2000

Medical Monitor 3000

Regulatory Affairs Personnel 3000

Medical Writer 1000

Quality Control Assurance Personnel 2000

Data Management Personnel 7000

Bio Statistician 500

Research Scientist 2000

Lab Personnel 1500

Management amp Administrative Personnel 2000

WHY SATRISHI INSTITUTE OF CLINICAL RESEARCH (SICR)SICR is a premier training amp research institute in Clinical Research campaigns by RAHE Group of Organization in bull the auspicious of the KPS Clinical Services Pvt Ltd (An Indian Based CRO)SICR was established in 2008 to provide Quality of Education to clinical research profession aspirants amp encouraged bull by the response in graduate coursesSICR is the only Institute in the entire India which is involved in total spectrum of practical training with help of bull Team of KPS Clinical ServicesSICR will be a leading Clinical Research training provider by delivering compelling appraises suggestion and quality bull education in Clinical Research to every individual irrespective of caste creed social or religious background

and to make them world class professionalsbull SICR will provide clinical research practical oriented training through passion of Christ for excellence and bull unbendable commitment

ABOUT KPS CLINICAL SERVICES PVT LTDKPS Clinical Services is a Contract Research Organization (CRO) providing variety of services for clinical trials bull and pharmaceutical regulatory affairs in IndiaKPS Clinical Services (KPSCS) is a pioneer in the concept to develop a way to ease suffering to enhance the quality bull of life and to overcome the hurdles in clinical research It is aimed at providing world-class clinical research services to pharmaceutical biotechnology medical device companies academic and government organizationsKPSCS believes in applying innovative technologies amp therapeutic expertise with a commitment to quality to bull enhance quality of life amp to help our clients amp partners in maximizing their returns on investment and accelerate the delivery of safe and effective therapeutics to patientsKPSCS offers a training program in clinical research that is Professional Diploma in Clinical Trial Management bull running under RAHE-Group of organizations for recent graduates in pharmaceutical science medical science dental science and life sciences who are interested in pursuing a career in clinical researchKPSCS is Indiarsquos one of the best training center offers High Quality Professional Training Programs in Clinical bull Research through Classroom Weekend Classes and distance learning programsGood Clinical Practice (GCP) guidelines and regulations like Schedule Y USFDA CFR Part 21 EMEA MHRA bull govern clinical trials and a thorough knowledge of guidelines and regulations at every stage of the clinical trial process is essential KPSCS helps the students and working professionals in achieving the level of expertise required through its high quality comprehensive user friendly and cost effective training programs ndash whether you need to train for a career in clinical trials update your knowledge with current information or equip with the new skills in this areaClinical Research and its allied fields today offers most attractive and innovative career opportunities to the bull graduates and post graduates in India and Abroad(MD MBBS BDS BAMS BHMS BUMS BPT Biochemistry Biotechnology Microbiology Pharmacy Pharmacology Life Sciences and other allied life sciences streams)We at KPS Clinical Services Pvt Ltd are committed towards developing India as a hub for global clinical research bull by catering to the ever-growing training and compliance needs of the profession through specialized training courses and workshops pharmaceutical companies Hospitals contract research organizations (CROs) research amp academic institutions etc as job prospects

TrainingObjective(s)

1 To provide an in-depth knowledge amp opportunity for skills development in Clinical research2 To nurture the culture of 100 clinical research-Competency development

Target audience Specialization in clinical research professionals employed in pharmaceutical companies Hospitals contract research organizations (CROs) research amp academic institutions etc as job prospects

Mukesh Kumar MPharm (Clinical Pharmacy) CPSR (USA) Director-Clinical Operation amp QA KPS Clinical Services Pvt Ltd Having more than 6 years clinical research experience as Clinical Research Coordinator Clinical Research Associate and Project Manager in various oncology trials (sponsored by Govt of India) across various Indian hospitalsbull Editor-in chief The Clinical Research Plus(TCRP) Magazinebull Vice President of IYPA (Indian Youth Pharmaceutical Association)bull Awarded certificate of FDA Med Watch and patient safety from US FDAbull Awarded certificate for membership of ISCR (Indian Society of Clinical Research)bull Executive Member of scrutiny council Clinical Research Board Indiabull Member of IPGA Indiabull Member Advisory Board Mytech professional

Industry SpeaksldquoIn the Clinical Research industry the need of the hour is professionals with the right balance of Clinical Research Education and Management knowledge SICR with its focus on management curriculum creates professionals who are ready to play the role the industry demandsrdquo

Dr Sanjeev Investigator Novartis UK

ldquoAs the Clinical Research industry grows there is a greater requirement for professionals who need to uphold the safety and ethical standards in clinical trials SICR with its commitment to provide ethical education can meet the industry expectationsrdquo

Dr MMirManager-QA Fortis clinical services Pvt Ltd

ldquoTime is an important factor during clinical trials There is a requirement for professionals who can quickly learn the operations and functions without any time-consuming training The industry-endorsed curriculum and training at SICR ensures students emerging out of SICR are thoroughly prepared for the challenges aheadrdquo

Dr TanvirProfessor- Department of Pharmacy- AMITY University

CLINICAL RESEARCH PROGRAMS OFFERED BY SICR

SNo Course Duration Fees

1 Post Graduate Diploma in ClinicalResearch (PGDCR)

1 Year(Regular Course) 98000-

2 Post Graduate Diploma in ClinicalData Management (PGDCDM)

1 Year(Regular Course) 158800-

3 Professional Diploma in ClinicalTrial Management (PDCTM)

6 Months(Distance Learning)

8600- (For Indian Students)

US$ 300 (For Abroad Students)

4 Professional Diploma inPharmacovigilance (PDPhV)

6 Months(Distance Learning)

8800- (For Indian Students)

US$ 350 (For Abroad Students)

5 Professional Diploma in DrugRegulatory Affairs (PDDRA)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

6Professional Diploma in

Intellectual Property Right(PDIPR)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

7Professional Diploma in Clinical

Pharmacy Management(PDCPM)

6 Months(Distance Learning)

7500- (For Indian Students)

US$ 295 (For Abroad Students)

8Professional Diploma in Hospital

Pharmacy Management(PDHPM)

6 Months(Distance Learning)

6400- (For Indian Students)

US$ 255 (For Abroad Students)

(The Clinical Research Plus (Indiarsquos First Clinical Research Magazine)wwwtcrpin

Satrishi Institute of Clinical ResearchF-215216 II Floor Neelkanth Plaza Alpha Commercial BeltAlpha I Greater Noida GB Nagar (UP) INDIA ndash 201306Ph 0120-423172021 Fax 0120-4213840 M 08750047473

Email- infosicrin Website- wwwsicrin

Specialty In the visual appearance of

CLINICAL ACADEMIC TRAININGbull 1048766 GCP Guideline workshop 1048766 Site Selection amp Management workshop 1048766 Industry Training Certificate in Clinical Research

CLINICAL SERVICESbull CLINICAL TRIAL EXECUTION Phase I Clinical Trials Phase II-IV Clinical Trials bull Project Management bull Clinical Trial Monitoring bull Clinical Trial Site management 1048766 REGULATORY AFFAIRS 1048766 QUALITY ASSURANCE (QA) 1048766 MEDICAL WRITING AND TRANSLATION bull Protocol Design bull Essential Clinical Trial Documents 1048766 POST-MARKETING SURVEILLANCE 1048766 TDM amp DATA MANAGEMENT

KPS Clinical Services Pvt LtdA Contract Research Organization

Clinical Research

Nine of the top fifteen global pharmaceutical and biotech companies have set up captive clinical research centers in bull the country Viz Pfizer Bayer GlaxoSmithKline Johnson amp Johnson Sanofi- Aventis AstraZeneca Merck amp Co Abbott Laboratories Wyeth Bristol-Myers Squibb Eli Lilly and CompanySeven of the top Nine global CROs have an established India presence Like Quintiles Covance PPD ICON bull Parexel MDS Kendle PharmaNet Development and PRA InternationalWhile the number of studies is comparable with most emerging markets the mean patient enrolment rates in India bull are higher by nearly 15- 20 as compared to other emerging economiesOver 60 CROs offer Phase I to IV trials complying with ICH-GCP guidelinesbull India has some of the top medicalscientific universities in Asiabull Sophisticated technological infrastructure 100 million plus English speaking people (Largest outside US)bull Over 2 million science post graduates and increasingbull Large pool of treatment naiumlve patients from multiethnic and multiracial backgroundsbull Cost effective operationsbull Higher GMPGLPGCP Compliancebull Maximum number of approved GMP plants outside USAbull Excellent quality management technology and infrastructurebull Strong IT industry amp availability of IT skilled manpowerbull USFDA has set up office in India ndash this shows Indiarsquos importance in the global clinical research and Pharma spacebull ICMRrsquos National Institute of Medical Statistics (NIMS) has set up the Clinical Trials Registry- India (CTRI) for bull registration of all clinical trials conducted in the country

Why Career in Clinical Researchbull Fastest growing segment in the healthcare pharmaceutical industry globallybull Excellent Opportunity to Develop Combination of Technical and Management Skill Developmentbull Part of the Global Growth Opportunitybull Wider Job Horizonbull Rapidly Growing Opportunitieshellip and growing (internal and external)bull Attractive Compensation and future growthbull Higher Job Satisfactionbull Continuous Training Opportunitiesbull International Working and Training Opportunitiesbull Huge Demand amp Supply Gap Easy Entrybull Good Career Prospectsbull Quickies (quick money growth on the ladder)bull Understanding of Drugs Diseases amp Management

Clinical Research Career - Are you EligibleClinical Research has created several thousand new job opportunities in India from in the last few years and it has showed its reflection in Indian Economy too More new job opportunities would be created in the coming years Clinical Research opened a wide range of manpower requirement in different fields like Clinical Research as core and specialized fields like Pharmacovigilance Regulatory Affairs Quality Assurance Auditing amp Inspection Medical Writing Biostatistics Clinical Data Management BABE Studies Bio Analytics Medical Device trials and some opportunities in non core areas like language translation services logistic services etc

A nation with more than 1 billion people India has the second largest population in the world India is being recognized as potential geography to conduct global trials since India became a member of the World Trade Organization (WTO) in 1995 and agreed to adhere to the product patent regime by 2005 As a result the global pharmaceutical industry has the rights to patent products as well as processes throughout the world including India This has led to a significant growth of the pharmaceutical industry both domestically in India and globally including increased stakes of multinational companies in Indian operations

As mentioned above there are several job opportunities for the graduates and post graduates in Medical Dental Homeopathic Ayurvedic Physiotherapy Pharmacy Life Sciences Biochemistry Microbiology Science and Mathematics Students However selecting a suitable job function according to your academic qualification experience and interest is crucial and this may require clear understanding of the job profile

Career PathwaysPharmaceutical Biotech CompaniesThe pharmaceuticalBiotech company develops produces and markets drugs licensed for use as medications Pharmaceutical companies can deal in generic andor brand medications They are subject to a variety of laws and regulations regarding the patenting testing and marketing of drugsEg Aventis Pharma Limited Biocon Cadila Healthcare Limited Cipla Limited Dr Reddys Laboratories Glaxo SmithKline Pharmaceuticals Limited Wockhardt Limited JB Chemicals Serum Institute of India Ranbaxy Laboratories Nicholas Piramal Pfizer Ranbaxy Elli Lilly etc

Clinical CROs (Contract Research Organizations)A Contract Research Organization also called a Clinical Research Organization (CRO) is a service organization that provides support to the pharmaceutical and biotechnology industries CROs offer clients a wide range of outsourced pharmaceutical research services to aid in the drug and medical device research and development processEg Covance Parexel Chiltern PRA International MDS Lambda Quintiles GVK PPD Reliance Life Sciences KPS Clinical Services Pvt Ltd etc

BABE CentersConduct Bio Availability amp Bio equivalence studies The BABE studies are performed for generic drugs new drug delivery systems and new chemical entitiesEg Synchron Lambda Therapeutics Lotus Lab Vimta Lab Wellquest Jubilant LG Life Science etc

SMOSite Management Organizations are responsible for managing clinical trial investigational site by providing required assistance staffs and other requirementsEg Neeman Medical Odyssey Research Accunova SMO India Excell Life Sciences etc

Data Management CROsClinical Data Management CROs assist in data entry data tracking amp reporting CRF creation amp design database reporting amp testing medical coding amp review and adverse event reportingEg Quintiles Synchron Cognizant SIRO Accenture DnO ClinInvent TCS IBM HCL etc

Medical Writing CompaniesMedical Writing company will creates documents that effectively and clearly describe research results product use and other medical information working with doctors scientists and other subject matter experts The medical writer also makes sure the documents comply with regulatory journal or other guidelines in terms of content format and structureEg Promed Kinapse MMS Holdings Laxai Avanti GVK Green Technologies Makro Care etc

EDC Service ProvidersIn India now clinical trials exposed to advanced technologies like electronic data capture for the ease and accurate data capture from the investigational sitesEg Quintiles Reliance communication limited Bio Clinica etc

Central LaboratoriesCentral laboratories are indispensible part of clinical trials as it is requires regular basis of laboratory specimen analysis profiling etc In clinical trials the importance of central laboratories are high compare to basic clinical laboratory testing as clinical trial requires uniformity in testing of sample all across the sitesEg ACM Global Central lab BAAP Diagnostics Ltd Diagnosearch Intervein Laboratories PvtLtd Lambda Therapeutic Research Medpace Metropolis Health Service Piramal Diagnostic Services

HospitalsClinics -Investigator amp Site StaffIn clinical trial language hospitalsclinics are usually known as investigational Site Investigators normally doctors by profession who conduct clinical trial according to the protocol provided by the sponsor and other rules and regulations Apart from the investigators a clinical trial site required minimum number of staffs to coordinate clinical trial activities in the siteEg AIIMS MAX Hospitals Escorts Fortis Medicity PGIMER Chandigarh etc

Training CentresAs clinical trial exponentially grew in India and It also calls for the training necessity for the better work culture and maintain the ethics of clinical trials in India Training centers are playing a crucial role in creating good professionals in clinical research conduct area and it requires continuous training for the experienced professional also towards the new trends and advancements

Job Opportunities for the Next Four YearsPosition Approx Number

Clinical Research Associate (CRA) Clinical Monitor 7000

Clinical research Coordinator (CRC) Site Coordinator 20000

Drug Safety Personnel 3000

Investigator 12000

Project Personnel 2000

Medical Monitor 3000

Regulatory Affairs Personnel 3000

Medical Writer 1000

Quality Control Assurance Personnel 2000

Data Management Personnel 7000

Bio Statistician 500

Research Scientist 2000

Lab Personnel 1500

Management amp Administrative Personnel 2000

WHY SATRISHI INSTITUTE OF CLINICAL RESEARCH (SICR)SICR is a premier training amp research institute in Clinical Research campaigns by RAHE Group of Organization in bull the auspicious of the KPS Clinical Services Pvt Ltd (An Indian Based CRO)SICR was established in 2008 to provide Quality of Education to clinical research profession aspirants amp encouraged bull by the response in graduate coursesSICR is the only Institute in the entire India which is involved in total spectrum of practical training with help of bull Team of KPS Clinical ServicesSICR will be a leading Clinical Research training provider by delivering compelling appraises suggestion and quality bull education in Clinical Research to every individual irrespective of caste creed social or religious background

and to make them world class professionalsbull SICR will provide clinical research practical oriented training through passion of Christ for excellence and bull unbendable commitment

ABOUT KPS CLINICAL SERVICES PVT LTDKPS Clinical Services is a Contract Research Organization (CRO) providing variety of services for clinical trials bull and pharmaceutical regulatory affairs in IndiaKPS Clinical Services (KPSCS) is a pioneer in the concept to develop a way to ease suffering to enhance the quality bull of life and to overcome the hurdles in clinical research It is aimed at providing world-class clinical research services to pharmaceutical biotechnology medical device companies academic and government organizationsKPSCS believes in applying innovative technologies amp therapeutic expertise with a commitment to quality to bull enhance quality of life amp to help our clients amp partners in maximizing their returns on investment and accelerate the delivery of safe and effective therapeutics to patientsKPSCS offers a training program in clinical research that is Professional Diploma in Clinical Trial Management bull running under RAHE-Group of organizations for recent graduates in pharmaceutical science medical science dental science and life sciences who are interested in pursuing a career in clinical researchKPSCS is Indiarsquos one of the best training center offers High Quality Professional Training Programs in Clinical bull Research through Classroom Weekend Classes and distance learning programsGood Clinical Practice (GCP) guidelines and regulations like Schedule Y USFDA CFR Part 21 EMEA MHRA bull govern clinical trials and a thorough knowledge of guidelines and regulations at every stage of the clinical trial process is essential KPSCS helps the students and working professionals in achieving the level of expertise required through its high quality comprehensive user friendly and cost effective training programs ndash whether you need to train for a career in clinical trials update your knowledge with current information or equip with the new skills in this areaClinical Research and its allied fields today offers most attractive and innovative career opportunities to the bull graduates and post graduates in India and Abroad(MD MBBS BDS BAMS BHMS BUMS BPT Biochemistry Biotechnology Microbiology Pharmacy Pharmacology Life Sciences and other allied life sciences streams)We at KPS Clinical Services Pvt Ltd are committed towards developing India as a hub for global clinical research bull by catering to the ever-growing training and compliance needs of the profession through specialized training courses and workshops pharmaceutical companies Hospitals contract research organizations (CROs) research amp academic institutions etc as job prospects

TrainingObjective(s)

1 To provide an in-depth knowledge amp opportunity for skills development in Clinical research2 To nurture the culture of 100 clinical research-Competency development

Target audience Specialization in clinical research professionals employed in pharmaceutical companies Hospitals contract research organizations (CROs) research amp academic institutions etc as job prospects

Mukesh Kumar MPharm (Clinical Pharmacy) CPSR (USA) Director-Clinical Operation amp QA KPS Clinical Services Pvt Ltd Having more than 6 years clinical research experience as Clinical Research Coordinator Clinical Research Associate and Project Manager in various oncology trials (sponsored by Govt of India) across various Indian hospitalsbull Editor-in chief The Clinical Research Plus(TCRP) Magazinebull Vice President of IYPA (Indian Youth Pharmaceutical Association)bull Awarded certificate of FDA Med Watch and patient safety from US FDAbull Awarded certificate for membership of ISCR (Indian Society of Clinical Research)bull Executive Member of scrutiny council Clinical Research Board Indiabull Member of IPGA Indiabull Member Advisory Board Mytech professional

Industry SpeaksldquoIn the Clinical Research industry the need of the hour is professionals with the right balance of Clinical Research Education and Management knowledge SICR with its focus on management curriculum creates professionals who are ready to play the role the industry demandsrdquo

Dr Sanjeev Investigator Novartis UK

ldquoAs the Clinical Research industry grows there is a greater requirement for professionals who need to uphold the safety and ethical standards in clinical trials SICR with its commitment to provide ethical education can meet the industry expectationsrdquo

Dr MMirManager-QA Fortis clinical services Pvt Ltd

ldquoTime is an important factor during clinical trials There is a requirement for professionals who can quickly learn the operations and functions without any time-consuming training The industry-endorsed curriculum and training at SICR ensures students emerging out of SICR are thoroughly prepared for the challenges aheadrdquo

Dr TanvirProfessor- Department of Pharmacy- AMITY University

CLINICAL RESEARCH PROGRAMS OFFERED BY SICR

SNo Course Duration Fees

1 Post Graduate Diploma in ClinicalResearch (PGDCR)

1 Year(Regular Course) 98000-

2 Post Graduate Diploma in ClinicalData Management (PGDCDM)

1 Year(Regular Course) 158800-

3 Professional Diploma in ClinicalTrial Management (PDCTM)

6 Months(Distance Learning)

8600- (For Indian Students)

US$ 300 (For Abroad Students)

4 Professional Diploma inPharmacovigilance (PDPhV)

6 Months(Distance Learning)

8800- (For Indian Students)

US$ 350 (For Abroad Students)

5 Professional Diploma in DrugRegulatory Affairs (PDDRA)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

6Professional Diploma in

Intellectual Property Right(PDIPR)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

7Professional Diploma in Clinical

Pharmacy Management(PDCPM)

6 Months(Distance Learning)

7500- (For Indian Students)

US$ 295 (For Abroad Students)

8Professional Diploma in Hospital

Pharmacy Management(PDHPM)

6 Months(Distance Learning)

6400- (For Indian Students)

US$ 255 (For Abroad Students)

(The Clinical Research Plus (Indiarsquos First Clinical Research Magazine)wwwtcrpin

Satrishi Institute of Clinical ResearchF-215216 II Floor Neelkanth Plaza Alpha Commercial BeltAlpha I Greater Noida GB Nagar (UP) INDIA ndash 201306Ph 0120-423172021 Fax 0120-4213840 M 08750047473

Email- infosicrin Website- wwwsicrin

Specialty In the visual appearance of

CLINICAL ACADEMIC TRAININGbull 1048766 GCP Guideline workshop 1048766 Site Selection amp Management workshop 1048766 Industry Training Certificate in Clinical Research

CLINICAL SERVICESbull CLINICAL TRIAL EXECUTION Phase I Clinical Trials Phase II-IV Clinical Trials bull Project Management bull Clinical Trial Monitoring bull Clinical Trial Site management 1048766 REGULATORY AFFAIRS 1048766 QUALITY ASSURANCE (QA) 1048766 MEDICAL WRITING AND TRANSLATION bull Protocol Design bull Essential Clinical Trial Documents 1048766 POST-MARKETING SURVEILLANCE 1048766 TDM amp DATA MANAGEMENT

KPS Clinical Services Pvt LtdA Contract Research Organization

Clinical Research

As mentioned above there are several job opportunities for the graduates and post graduates in Medical Dental Homeopathic Ayurvedic Physiotherapy Pharmacy Life Sciences Biochemistry Microbiology Science and Mathematics Students However selecting a suitable job function according to your academic qualification experience and interest is crucial and this may require clear understanding of the job profile

Career PathwaysPharmaceutical Biotech CompaniesThe pharmaceuticalBiotech company develops produces and markets drugs licensed for use as medications Pharmaceutical companies can deal in generic andor brand medications They are subject to a variety of laws and regulations regarding the patenting testing and marketing of drugsEg Aventis Pharma Limited Biocon Cadila Healthcare Limited Cipla Limited Dr Reddys Laboratories Glaxo SmithKline Pharmaceuticals Limited Wockhardt Limited JB Chemicals Serum Institute of India Ranbaxy Laboratories Nicholas Piramal Pfizer Ranbaxy Elli Lilly etc

Clinical CROs (Contract Research Organizations)A Contract Research Organization also called a Clinical Research Organization (CRO) is a service organization that provides support to the pharmaceutical and biotechnology industries CROs offer clients a wide range of outsourced pharmaceutical research services to aid in the drug and medical device research and development processEg Covance Parexel Chiltern PRA International MDS Lambda Quintiles GVK PPD Reliance Life Sciences KPS Clinical Services Pvt Ltd etc

BABE CentersConduct Bio Availability amp Bio equivalence studies The BABE studies are performed for generic drugs new drug delivery systems and new chemical entitiesEg Synchron Lambda Therapeutics Lotus Lab Vimta Lab Wellquest Jubilant LG Life Science etc

SMOSite Management Organizations are responsible for managing clinical trial investigational site by providing required assistance staffs and other requirementsEg Neeman Medical Odyssey Research Accunova SMO India Excell Life Sciences etc

Data Management CROsClinical Data Management CROs assist in data entry data tracking amp reporting CRF creation amp design database reporting amp testing medical coding amp review and adverse event reportingEg Quintiles Synchron Cognizant SIRO Accenture DnO ClinInvent TCS IBM HCL etc

Medical Writing CompaniesMedical Writing company will creates documents that effectively and clearly describe research results product use and other medical information working with doctors scientists and other subject matter experts The medical writer also makes sure the documents comply with regulatory journal or other guidelines in terms of content format and structureEg Promed Kinapse MMS Holdings Laxai Avanti GVK Green Technologies Makro Care etc

EDC Service ProvidersIn India now clinical trials exposed to advanced technologies like electronic data capture for the ease and accurate data capture from the investigational sitesEg Quintiles Reliance communication limited Bio Clinica etc

Central LaboratoriesCentral laboratories are indispensible part of clinical trials as it is requires regular basis of laboratory specimen analysis profiling etc In clinical trials the importance of central laboratories are high compare to basic clinical laboratory testing as clinical trial requires uniformity in testing of sample all across the sitesEg ACM Global Central lab BAAP Diagnostics Ltd Diagnosearch Intervein Laboratories PvtLtd Lambda Therapeutic Research Medpace Metropolis Health Service Piramal Diagnostic Services

HospitalsClinics -Investigator amp Site StaffIn clinical trial language hospitalsclinics are usually known as investigational Site Investigators normally doctors by profession who conduct clinical trial according to the protocol provided by the sponsor and other rules and regulations Apart from the investigators a clinical trial site required minimum number of staffs to coordinate clinical trial activities in the siteEg AIIMS MAX Hospitals Escorts Fortis Medicity PGIMER Chandigarh etc

Training CentresAs clinical trial exponentially grew in India and It also calls for the training necessity for the better work culture and maintain the ethics of clinical trials in India Training centers are playing a crucial role in creating good professionals in clinical research conduct area and it requires continuous training for the experienced professional also towards the new trends and advancements

Job Opportunities for the Next Four YearsPosition Approx Number

Clinical Research Associate (CRA) Clinical Monitor 7000

Clinical research Coordinator (CRC) Site Coordinator 20000

Drug Safety Personnel 3000

Investigator 12000

Project Personnel 2000

Medical Monitor 3000

Regulatory Affairs Personnel 3000

Medical Writer 1000

Quality Control Assurance Personnel 2000

Data Management Personnel 7000

Bio Statistician 500

Research Scientist 2000

Lab Personnel 1500

Management amp Administrative Personnel 2000

WHY SATRISHI INSTITUTE OF CLINICAL RESEARCH (SICR)SICR is a premier training amp research institute in Clinical Research campaigns by RAHE Group of Organization in bull the auspicious of the KPS Clinical Services Pvt Ltd (An Indian Based CRO)SICR was established in 2008 to provide Quality of Education to clinical research profession aspirants amp encouraged bull by the response in graduate coursesSICR is the only Institute in the entire India which is involved in total spectrum of practical training with help of bull Team of KPS Clinical ServicesSICR will be a leading Clinical Research training provider by delivering compelling appraises suggestion and quality bull education in Clinical Research to every individual irrespective of caste creed social or religious background

and to make them world class professionalsbull SICR will provide clinical research practical oriented training through passion of Christ for excellence and bull unbendable commitment

ABOUT KPS CLINICAL SERVICES PVT LTDKPS Clinical Services is a Contract Research Organization (CRO) providing variety of services for clinical trials bull and pharmaceutical regulatory affairs in IndiaKPS Clinical Services (KPSCS) is a pioneer in the concept to develop a way to ease suffering to enhance the quality bull of life and to overcome the hurdles in clinical research It is aimed at providing world-class clinical research services to pharmaceutical biotechnology medical device companies academic and government organizationsKPSCS believes in applying innovative technologies amp therapeutic expertise with a commitment to quality to bull enhance quality of life amp to help our clients amp partners in maximizing their returns on investment and accelerate the delivery of safe and effective therapeutics to patientsKPSCS offers a training program in clinical research that is Professional Diploma in Clinical Trial Management bull running under RAHE-Group of organizations for recent graduates in pharmaceutical science medical science dental science and life sciences who are interested in pursuing a career in clinical researchKPSCS is Indiarsquos one of the best training center offers High Quality Professional Training Programs in Clinical bull Research through Classroom Weekend Classes and distance learning programsGood Clinical Practice (GCP) guidelines and regulations like Schedule Y USFDA CFR Part 21 EMEA MHRA bull govern clinical trials and a thorough knowledge of guidelines and regulations at every stage of the clinical trial process is essential KPSCS helps the students and working professionals in achieving the level of expertise required through its high quality comprehensive user friendly and cost effective training programs ndash whether you need to train for a career in clinical trials update your knowledge with current information or equip with the new skills in this areaClinical Research and its allied fields today offers most attractive and innovative career opportunities to the bull graduates and post graduates in India and Abroad(MD MBBS BDS BAMS BHMS BUMS BPT Biochemistry Biotechnology Microbiology Pharmacy Pharmacology Life Sciences and other allied life sciences streams)We at KPS Clinical Services Pvt Ltd are committed towards developing India as a hub for global clinical research bull by catering to the ever-growing training and compliance needs of the profession through specialized training courses and workshops pharmaceutical companies Hospitals contract research organizations (CROs) research amp academic institutions etc as job prospects

TrainingObjective(s)

1 To provide an in-depth knowledge amp opportunity for skills development in Clinical research2 To nurture the culture of 100 clinical research-Competency development

Target audience Specialization in clinical research professionals employed in pharmaceutical companies Hospitals contract research organizations (CROs) research amp academic institutions etc as job prospects

Mukesh Kumar MPharm (Clinical Pharmacy) CPSR (USA) Director-Clinical Operation amp QA KPS Clinical Services Pvt Ltd Having more than 6 years clinical research experience as Clinical Research Coordinator Clinical Research Associate and Project Manager in various oncology trials (sponsored by Govt of India) across various Indian hospitalsbull Editor-in chief The Clinical Research Plus(TCRP) Magazinebull Vice President of IYPA (Indian Youth Pharmaceutical Association)bull Awarded certificate of FDA Med Watch and patient safety from US FDAbull Awarded certificate for membership of ISCR (Indian Society of Clinical Research)bull Executive Member of scrutiny council Clinical Research Board Indiabull Member of IPGA Indiabull Member Advisory Board Mytech professional

Industry SpeaksldquoIn the Clinical Research industry the need of the hour is professionals with the right balance of Clinical Research Education and Management knowledge SICR with its focus on management curriculum creates professionals who are ready to play the role the industry demandsrdquo

Dr Sanjeev Investigator Novartis UK

ldquoAs the Clinical Research industry grows there is a greater requirement for professionals who need to uphold the safety and ethical standards in clinical trials SICR with its commitment to provide ethical education can meet the industry expectationsrdquo

Dr MMirManager-QA Fortis clinical services Pvt Ltd

ldquoTime is an important factor during clinical trials There is a requirement for professionals who can quickly learn the operations and functions without any time-consuming training The industry-endorsed curriculum and training at SICR ensures students emerging out of SICR are thoroughly prepared for the challenges aheadrdquo

Dr TanvirProfessor- Department of Pharmacy- AMITY University

CLINICAL RESEARCH PROGRAMS OFFERED BY SICR

SNo Course Duration Fees

1 Post Graduate Diploma in ClinicalResearch (PGDCR)

1 Year(Regular Course) 98000-

2 Post Graduate Diploma in ClinicalData Management (PGDCDM)

1 Year(Regular Course) 158800-

3 Professional Diploma in ClinicalTrial Management (PDCTM)

6 Months(Distance Learning)

8600- (For Indian Students)

US$ 300 (For Abroad Students)

4 Professional Diploma inPharmacovigilance (PDPhV)

6 Months(Distance Learning)

8800- (For Indian Students)

US$ 350 (For Abroad Students)

5 Professional Diploma in DrugRegulatory Affairs (PDDRA)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

6Professional Diploma in

Intellectual Property Right(PDIPR)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

7Professional Diploma in Clinical

Pharmacy Management(PDCPM)

6 Months(Distance Learning)

7500- (For Indian Students)

US$ 295 (For Abroad Students)

8Professional Diploma in Hospital

Pharmacy Management(PDHPM)

6 Months(Distance Learning)

6400- (For Indian Students)

US$ 255 (For Abroad Students)

(The Clinical Research Plus (Indiarsquos First Clinical Research Magazine)wwwtcrpin

Satrishi Institute of Clinical ResearchF-215216 II Floor Neelkanth Plaza Alpha Commercial BeltAlpha I Greater Noida GB Nagar (UP) INDIA ndash 201306Ph 0120-423172021 Fax 0120-4213840 M 08750047473

Email- infosicrin Website- wwwsicrin

Specialty In the visual appearance of

CLINICAL ACADEMIC TRAININGbull 1048766 GCP Guideline workshop 1048766 Site Selection amp Management workshop 1048766 Industry Training Certificate in Clinical Research

CLINICAL SERVICESbull CLINICAL TRIAL EXECUTION Phase I Clinical Trials Phase II-IV Clinical Trials bull Project Management bull Clinical Trial Monitoring bull Clinical Trial Site management 1048766 REGULATORY AFFAIRS 1048766 QUALITY ASSURANCE (QA) 1048766 MEDICAL WRITING AND TRANSLATION bull Protocol Design bull Essential Clinical Trial Documents 1048766 POST-MARKETING SURVEILLANCE 1048766 TDM amp DATA MANAGEMENT

KPS Clinical Services Pvt LtdA Contract Research Organization

Clinical Research

Central LaboratoriesCentral laboratories are indispensible part of clinical trials as it is requires regular basis of laboratory specimen analysis profiling etc In clinical trials the importance of central laboratories are high compare to basic clinical laboratory testing as clinical trial requires uniformity in testing of sample all across the sitesEg ACM Global Central lab BAAP Diagnostics Ltd Diagnosearch Intervein Laboratories PvtLtd Lambda Therapeutic Research Medpace Metropolis Health Service Piramal Diagnostic Services

HospitalsClinics -Investigator amp Site StaffIn clinical trial language hospitalsclinics are usually known as investigational Site Investigators normally doctors by profession who conduct clinical trial according to the protocol provided by the sponsor and other rules and regulations Apart from the investigators a clinical trial site required minimum number of staffs to coordinate clinical trial activities in the siteEg AIIMS MAX Hospitals Escorts Fortis Medicity PGIMER Chandigarh etc

Training CentresAs clinical trial exponentially grew in India and It also calls for the training necessity for the better work culture and maintain the ethics of clinical trials in India Training centers are playing a crucial role in creating good professionals in clinical research conduct area and it requires continuous training for the experienced professional also towards the new trends and advancements

Job Opportunities for the Next Four YearsPosition Approx Number

Clinical Research Associate (CRA) Clinical Monitor 7000

Clinical research Coordinator (CRC) Site Coordinator 20000

Drug Safety Personnel 3000

Investigator 12000

Project Personnel 2000

Medical Monitor 3000

Regulatory Affairs Personnel 3000

Medical Writer 1000

Quality Control Assurance Personnel 2000

Data Management Personnel 7000

Bio Statistician 500

Research Scientist 2000

Lab Personnel 1500

Management amp Administrative Personnel 2000

WHY SATRISHI INSTITUTE OF CLINICAL RESEARCH (SICR)SICR is a premier training amp research institute in Clinical Research campaigns by RAHE Group of Organization in bull the auspicious of the KPS Clinical Services Pvt Ltd (An Indian Based CRO)SICR was established in 2008 to provide Quality of Education to clinical research profession aspirants amp encouraged bull by the response in graduate coursesSICR is the only Institute in the entire India which is involved in total spectrum of practical training with help of bull Team of KPS Clinical ServicesSICR will be a leading Clinical Research training provider by delivering compelling appraises suggestion and quality bull education in Clinical Research to every individual irrespective of caste creed social or religious background

and to make them world class professionalsbull SICR will provide clinical research practical oriented training through passion of Christ for excellence and bull unbendable commitment

ABOUT KPS CLINICAL SERVICES PVT LTDKPS Clinical Services is a Contract Research Organization (CRO) providing variety of services for clinical trials bull and pharmaceutical regulatory affairs in IndiaKPS Clinical Services (KPSCS) is a pioneer in the concept to develop a way to ease suffering to enhance the quality bull of life and to overcome the hurdles in clinical research It is aimed at providing world-class clinical research services to pharmaceutical biotechnology medical device companies academic and government organizationsKPSCS believes in applying innovative technologies amp therapeutic expertise with a commitment to quality to bull enhance quality of life amp to help our clients amp partners in maximizing their returns on investment and accelerate the delivery of safe and effective therapeutics to patientsKPSCS offers a training program in clinical research that is Professional Diploma in Clinical Trial Management bull running under RAHE-Group of organizations for recent graduates in pharmaceutical science medical science dental science and life sciences who are interested in pursuing a career in clinical researchKPSCS is Indiarsquos one of the best training center offers High Quality Professional Training Programs in Clinical bull Research through Classroom Weekend Classes and distance learning programsGood Clinical Practice (GCP) guidelines and regulations like Schedule Y USFDA CFR Part 21 EMEA MHRA bull govern clinical trials and a thorough knowledge of guidelines and regulations at every stage of the clinical trial process is essential KPSCS helps the students and working professionals in achieving the level of expertise required through its high quality comprehensive user friendly and cost effective training programs ndash whether you need to train for a career in clinical trials update your knowledge with current information or equip with the new skills in this areaClinical Research and its allied fields today offers most attractive and innovative career opportunities to the bull graduates and post graduates in India and Abroad(MD MBBS BDS BAMS BHMS BUMS BPT Biochemistry Biotechnology Microbiology Pharmacy Pharmacology Life Sciences and other allied life sciences streams)We at KPS Clinical Services Pvt Ltd are committed towards developing India as a hub for global clinical research bull by catering to the ever-growing training and compliance needs of the profession through specialized training courses and workshops pharmaceutical companies Hospitals contract research organizations (CROs) research amp academic institutions etc as job prospects

TrainingObjective(s)

1 To provide an in-depth knowledge amp opportunity for skills development in Clinical research2 To nurture the culture of 100 clinical research-Competency development

Target audience Specialization in clinical research professionals employed in pharmaceutical companies Hospitals contract research organizations (CROs) research amp academic institutions etc as job prospects

Mukesh Kumar MPharm (Clinical Pharmacy) CPSR (USA) Director-Clinical Operation amp QA KPS Clinical Services Pvt Ltd Having more than 6 years clinical research experience as Clinical Research Coordinator Clinical Research Associate and Project Manager in various oncology trials (sponsored by Govt of India) across various Indian hospitalsbull Editor-in chief The Clinical Research Plus(TCRP) Magazinebull Vice President of IYPA (Indian Youth Pharmaceutical Association)bull Awarded certificate of FDA Med Watch and patient safety from US FDAbull Awarded certificate for membership of ISCR (Indian Society of Clinical Research)bull Executive Member of scrutiny council Clinical Research Board Indiabull Member of IPGA Indiabull Member Advisory Board Mytech professional

Industry SpeaksldquoIn the Clinical Research industry the need of the hour is professionals with the right balance of Clinical Research Education and Management knowledge SICR with its focus on management curriculum creates professionals who are ready to play the role the industry demandsrdquo

Dr Sanjeev Investigator Novartis UK

ldquoAs the Clinical Research industry grows there is a greater requirement for professionals who need to uphold the safety and ethical standards in clinical trials SICR with its commitment to provide ethical education can meet the industry expectationsrdquo

Dr MMirManager-QA Fortis clinical services Pvt Ltd

ldquoTime is an important factor during clinical trials There is a requirement for professionals who can quickly learn the operations and functions without any time-consuming training The industry-endorsed curriculum and training at SICR ensures students emerging out of SICR are thoroughly prepared for the challenges aheadrdquo

Dr TanvirProfessor- Department of Pharmacy- AMITY University

CLINICAL RESEARCH PROGRAMS OFFERED BY SICR

SNo Course Duration Fees

1 Post Graduate Diploma in ClinicalResearch (PGDCR)

1 Year(Regular Course) 98000-

2 Post Graduate Diploma in ClinicalData Management (PGDCDM)

1 Year(Regular Course) 158800-

3 Professional Diploma in ClinicalTrial Management (PDCTM)

6 Months(Distance Learning)

8600- (For Indian Students)

US$ 300 (For Abroad Students)

4 Professional Diploma inPharmacovigilance (PDPhV)

6 Months(Distance Learning)

8800- (For Indian Students)

US$ 350 (For Abroad Students)

5 Professional Diploma in DrugRegulatory Affairs (PDDRA)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

6Professional Diploma in

Intellectual Property Right(PDIPR)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

7Professional Diploma in Clinical

Pharmacy Management(PDCPM)

6 Months(Distance Learning)

7500- (For Indian Students)

US$ 295 (For Abroad Students)

8Professional Diploma in Hospital

Pharmacy Management(PDHPM)

6 Months(Distance Learning)

6400- (For Indian Students)

US$ 255 (For Abroad Students)

(The Clinical Research Plus (Indiarsquos First Clinical Research Magazine)wwwtcrpin

Satrishi Institute of Clinical ResearchF-215216 II Floor Neelkanth Plaza Alpha Commercial BeltAlpha I Greater Noida GB Nagar (UP) INDIA ndash 201306Ph 0120-423172021 Fax 0120-4213840 M 08750047473

Email- infosicrin Website- wwwsicrin

Specialty In the visual appearance of

CLINICAL ACADEMIC TRAININGbull 1048766 GCP Guideline workshop 1048766 Site Selection amp Management workshop 1048766 Industry Training Certificate in Clinical Research

CLINICAL SERVICESbull CLINICAL TRIAL EXECUTION Phase I Clinical Trials Phase II-IV Clinical Trials bull Project Management bull Clinical Trial Monitoring bull Clinical Trial Site management 1048766 REGULATORY AFFAIRS 1048766 QUALITY ASSURANCE (QA) 1048766 MEDICAL WRITING AND TRANSLATION bull Protocol Design bull Essential Clinical Trial Documents 1048766 POST-MARKETING SURVEILLANCE 1048766 TDM amp DATA MANAGEMENT

KPS Clinical Services Pvt LtdA Contract Research Organization

Clinical Research

and to make them world class professionalsbull SICR will provide clinical research practical oriented training through passion of Christ for excellence and bull unbendable commitment

ABOUT KPS CLINICAL SERVICES PVT LTDKPS Clinical Services is a Contract Research Organization (CRO) providing variety of services for clinical trials bull and pharmaceutical regulatory affairs in IndiaKPS Clinical Services (KPSCS) is a pioneer in the concept to develop a way to ease suffering to enhance the quality bull of life and to overcome the hurdles in clinical research It is aimed at providing world-class clinical research services to pharmaceutical biotechnology medical device companies academic and government organizationsKPSCS believes in applying innovative technologies amp therapeutic expertise with a commitment to quality to bull enhance quality of life amp to help our clients amp partners in maximizing their returns on investment and accelerate the delivery of safe and effective therapeutics to patientsKPSCS offers a training program in clinical research that is Professional Diploma in Clinical Trial Management bull running under RAHE-Group of organizations for recent graduates in pharmaceutical science medical science dental science and life sciences who are interested in pursuing a career in clinical researchKPSCS is Indiarsquos one of the best training center offers High Quality Professional Training Programs in Clinical bull Research through Classroom Weekend Classes and distance learning programsGood Clinical Practice (GCP) guidelines and regulations like Schedule Y USFDA CFR Part 21 EMEA MHRA bull govern clinical trials and a thorough knowledge of guidelines and regulations at every stage of the clinical trial process is essential KPSCS helps the students and working professionals in achieving the level of expertise required through its high quality comprehensive user friendly and cost effective training programs ndash whether you need to train for a career in clinical trials update your knowledge with current information or equip with the new skills in this areaClinical Research and its allied fields today offers most attractive and innovative career opportunities to the bull graduates and post graduates in India and Abroad(MD MBBS BDS BAMS BHMS BUMS BPT Biochemistry Biotechnology Microbiology Pharmacy Pharmacology Life Sciences and other allied life sciences streams)We at KPS Clinical Services Pvt Ltd are committed towards developing India as a hub for global clinical research bull by catering to the ever-growing training and compliance needs of the profession through specialized training courses and workshops pharmaceutical companies Hospitals contract research organizations (CROs) research amp academic institutions etc as job prospects

TrainingObjective(s)

1 To provide an in-depth knowledge amp opportunity for skills development in Clinical research2 To nurture the culture of 100 clinical research-Competency development

Target audience Specialization in clinical research professionals employed in pharmaceutical companies Hospitals contract research organizations (CROs) research amp academic institutions etc as job prospects

Mukesh Kumar MPharm (Clinical Pharmacy) CPSR (USA) Director-Clinical Operation amp QA KPS Clinical Services Pvt Ltd Having more than 6 years clinical research experience as Clinical Research Coordinator Clinical Research Associate and Project Manager in various oncology trials (sponsored by Govt of India) across various Indian hospitalsbull Editor-in chief The Clinical Research Plus(TCRP) Magazinebull Vice President of IYPA (Indian Youth Pharmaceutical Association)bull Awarded certificate of FDA Med Watch and patient safety from US FDAbull Awarded certificate for membership of ISCR (Indian Society of Clinical Research)bull Executive Member of scrutiny council Clinical Research Board Indiabull Member of IPGA Indiabull Member Advisory Board Mytech professional

Industry SpeaksldquoIn the Clinical Research industry the need of the hour is professionals with the right balance of Clinical Research Education and Management knowledge SICR with its focus on management curriculum creates professionals who are ready to play the role the industry demandsrdquo

Dr Sanjeev Investigator Novartis UK

ldquoAs the Clinical Research industry grows there is a greater requirement for professionals who need to uphold the safety and ethical standards in clinical trials SICR with its commitment to provide ethical education can meet the industry expectationsrdquo

Dr MMirManager-QA Fortis clinical services Pvt Ltd

ldquoTime is an important factor during clinical trials There is a requirement for professionals who can quickly learn the operations and functions without any time-consuming training The industry-endorsed curriculum and training at SICR ensures students emerging out of SICR are thoroughly prepared for the challenges aheadrdquo

Dr TanvirProfessor- Department of Pharmacy- AMITY University

CLINICAL RESEARCH PROGRAMS OFFERED BY SICR

SNo Course Duration Fees

1 Post Graduate Diploma in ClinicalResearch (PGDCR)

1 Year(Regular Course) 98000-

2 Post Graduate Diploma in ClinicalData Management (PGDCDM)

1 Year(Regular Course) 158800-

3 Professional Diploma in ClinicalTrial Management (PDCTM)

6 Months(Distance Learning)

8600- (For Indian Students)

US$ 300 (For Abroad Students)

4 Professional Diploma inPharmacovigilance (PDPhV)

6 Months(Distance Learning)

8800- (For Indian Students)

US$ 350 (For Abroad Students)

5 Professional Diploma in DrugRegulatory Affairs (PDDRA)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

6Professional Diploma in

Intellectual Property Right(PDIPR)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

7Professional Diploma in Clinical

Pharmacy Management(PDCPM)

6 Months(Distance Learning)

7500- (For Indian Students)

US$ 295 (For Abroad Students)

8Professional Diploma in Hospital

Pharmacy Management(PDHPM)

6 Months(Distance Learning)

6400- (For Indian Students)

US$ 255 (For Abroad Students)

(The Clinical Research Plus (Indiarsquos First Clinical Research Magazine)wwwtcrpin

Satrishi Institute of Clinical ResearchF-215216 II Floor Neelkanth Plaza Alpha Commercial BeltAlpha I Greater Noida GB Nagar (UP) INDIA ndash 201306Ph 0120-423172021 Fax 0120-4213840 M 08750047473

Email- infosicrin Website- wwwsicrin

Specialty In the visual appearance of

CLINICAL ACADEMIC TRAININGbull 1048766 GCP Guideline workshop 1048766 Site Selection amp Management workshop 1048766 Industry Training Certificate in Clinical Research

CLINICAL SERVICESbull CLINICAL TRIAL EXECUTION Phase I Clinical Trials Phase II-IV Clinical Trials bull Project Management bull Clinical Trial Monitoring bull Clinical Trial Site management 1048766 REGULATORY AFFAIRS 1048766 QUALITY ASSURANCE (QA) 1048766 MEDICAL WRITING AND TRANSLATION bull Protocol Design bull Essential Clinical Trial Documents 1048766 POST-MARKETING SURVEILLANCE 1048766 TDM amp DATA MANAGEMENT

KPS Clinical Services Pvt LtdA Contract Research Organization

Clinical Research

Industry SpeaksldquoIn the Clinical Research industry the need of the hour is professionals with the right balance of Clinical Research Education and Management knowledge SICR with its focus on management curriculum creates professionals who are ready to play the role the industry demandsrdquo

Dr Sanjeev Investigator Novartis UK

ldquoAs the Clinical Research industry grows there is a greater requirement for professionals who need to uphold the safety and ethical standards in clinical trials SICR with its commitment to provide ethical education can meet the industry expectationsrdquo

Dr MMirManager-QA Fortis clinical services Pvt Ltd

ldquoTime is an important factor during clinical trials There is a requirement for professionals who can quickly learn the operations and functions without any time-consuming training The industry-endorsed curriculum and training at SICR ensures students emerging out of SICR are thoroughly prepared for the challenges aheadrdquo

Dr TanvirProfessor- Department of Pharmacy- AMITY University

CLINICAL RESEARCH PROGRAMS OFFERED BY SICR

SNo Course Duration Fees

1 Post Graduate Diploma in ClinicalResearch (PGDCR)

1 Year(Regular Course) 98000-

2 Post Graduate Diploma in ClinicalData Management (PGDCDM)

1 Year(Regular Course) 158800-

3 Professional Diploma in ClinicalTrial Management (PDCTM)

6 Months(Distance Learning)

8600- (For Indian Students)

US$ 300 (For Abroad Students)

4 Professional Diploma inPharmacovigilance (PDPhV)

6 Months(Distance Learning)

8800- (For Indian Students)

US$ 350 (For Abroad Students)

5 Professional Diploma in DrugRegulatory Affairs (PDDRA)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

6Professional Diploma in

Intellectual Property Right(PDIPR)

6 Months(Distance Learning)

9600- (For Indian Students)

US$ 350 (For Abroad Students)

7Professional Diploma in Clinical

Pharmacy Management(PDCPM)

6 Months(Distance Learning)

7500- (For Indian Students)

US$ 295 (For Abroad Students)

8Professional Diploma in Hospital

Pharmacy Management(PDHPM)

6 Months(Distance Learning)

6400- (For Indian Students)

US$ 255 (For Abroad Students)

(The Clinical Research Plus (Indiarsquos First Clinical Research Magazine)wwwtcrpin

Satrishi Institute of Clinical ResearchF-215216 II Floor Neelkanth Plaza Alpha Commercial BeltAlpha I Greater Noida GB Nagar (UP) INDIA ndash 201306Ph 0120-423172021 Fax 0120-4213840 M 08750047473

Email- infosicrin Website- wwwsicrin

Specialty In the visual appearance of

CLINICAL ACADEMIC TRAININGbull 1048766 GCP Guideline workshop 1048766 Site Selection amp Management workshop 1048766 Industry Training Certificate in Clinical Research

CLINICAL SERVICESbull CLINICAL TRIAL EXECUTION Phase I Clinical Trials Phase II-IV Clinical Trials bull Project Management bull Clinical Trial Monitoring bull Clinical Trial Site management 1048766 REGULATORY AFFAIRS 1048766 QUALITY ASSURANCE (QA) 1048766 MEDICAL WRITING AND TRANSLATION bull Protocol Design bull Essential Clinical Trial Documents 1048766 POST-MARKETING SURVEILLANCE 1048766 TDM amp DATA MANAGEMENT

KPS Clinical Services Pvt LtdA Contract Research Organization

Clinical Research

(The Clinical Research Plus (Indiarsquos First Clinical Research Magazine)wwwtcrpin

Satrishi Institute of Clinical ResearchF-215216 II Floor Neelkanth Plaza Alpha Commercial BeltAlpha I Greater Noida GB Nagar (UP) INDIA ndash 201306Ph 0120-423172021 Fax 0120-4213840 M 08750047473

Email- infosicrin Website- wwwsicrin

Specialty In the visual appearance of

CLINICAL ACADEMIC TRAININGbull 1048766 GCP Guideline workshop 1048766 Site Selection amp Management workshop 1048766 Industry Training Certificate in Clinical Research

CLINICAL SERVICESbull CLINICAL TRIAL EXECUTION Phase I Clinical Trials Phase II-IV Clinical Trials bull Project Management bull Clinical Trial Monitoring bull Clinical Trial Site management 1048766 REGULATORY AFFAIRS 1048766 QUALITY ASSURANCE (QA) 1048766 MEDICAL WRITING AND TRANSLATION bull Protocol Design bull Essential Clinical Trial Documents 1048766 POST-MARKETING SURVEILLANCE 1048766 TDM amp DATA MANAGEMENT

KPS Clinical Services Pvt LtdA Contract Research Organization

Clinical Research