Hcr Bussiness Brochure

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Human Care Research Clinical Research Consulting & Site Management Organization (SMO) www.humancareresearch.com -- Excellence with Ethics & Quality

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Transcript of Hcr Bussiness Brochure

Page 1: Hcr Bussiness Brochure

Human Care Research

Clinical Research Consulting & Site

Management Organization (SMO)

www.humancareresearch.com

-- Excellence with Ethics & Quality

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Vision:

“Dedicated in providing superior clinical research to better the lives of all

those we serve with Ethics & Quality.”

Mission:

To help our customers to achieve their business objective by providing

superior medical research, be innovative , best-in-class consulting, clinical

research solution and services.

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Human Care Research is an independent consultant & a Site

Management Organization, created with passion whose sole purpose is to

support a successful outcome of clinical trials and to provide drug

Development which include pre-clinical, clinical research and Regulatory

services support to the Pharmaceutical, Biotechnology, Medical Device

Industry and Clinical site.

HCR offers wide range of services to Contract Research Organizations

and Pharmaceuticals for clinical trial services.

HCR, Mumbai (India) based, is a fully integrated research facility with

capabilities geared to provide services in all aspects of Clinical Trials.

HCR work with a network of qualified and experienced Principal

Investigators across India to provide safe, thorough and cost effective

management of clinical programs and business development consulting

through strict adherence to ICH/GCP guidelines, the Indian GCP, schedule

Y and US FDA regulations.

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HCR SERVICES

CLINICAL

CONSULTING

CONTRACT RESEARCH

ORGANIZATION

PRECLINICAL RESERCH

SITE MANAGEMENT ORGANIZATION

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HCR offers a complete spectrum of preclinical and clinical research services. We are as comfortable offering individual service components or executing a complete process.

Our services includes:

Project Management

Clinical Operations – Phase II-IV

Preclinical Operations – Toxicology /In vitro/In Vivo

Data Management Services

Medical Writing & Biostatistics

BA/ BE Study, First-in-Man Study

Central Lab Selection & co-ordination

Corporate Training

Regulatory Services

Pharmacovigilance and Safety Assessment

Patient Recruitment-Healthy volunteers / Patients for CT

Quality assurance

Translation of study documentation

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Site Feasibility Assessment & PI Selection, PI meeting

Clinical Research Documents Development: CRF / Protocol / ICF Design

Site Managements: Site initiation, Monitoring/Medical Monitoring, Site Closeout

Trial logistics, trial supplies

Clinical Monitoring of Phase I, II, III, and IV trials.

Audit of Clinical Trials

Study Team Training

Site Infrastructure Provisioning

IRB/EC Submission/Approval

DCGI Submission/Approval

Consulting & Regulatory Support Services

Documentation with Electronic Data Capture (EDC) expertise

Help-out for faster patients recruitment

Obtaining import and export licenses for new molecules/products.

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Clinical Trials Identifications

Budget and contract preparation and negotiation

Centralised communication between sites and the sponsor

Assistance with patient recruitment, including advertising campaigns

ICH-GCP Education to Clinical research staffs / PI

Selections of Contract research staff (experienced clinical trial co-

ordinators) and recruitments for PI sites

Developments of SOPs ( Site / trials specifics)

Site Coordination & Management

Management of patients recruitments strategies /advertisement campaign

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Design course syllabus-Clinical Research

Conduct Clinical Research (GCP) Training

Placement services

Help PhD Student for supply chemicals / products samples

Research people provide Journals articles

Corporate Training Services (ICH GCP, CRA/CRC, Site/Investigator)

Ethical approval for student research

Arrangement of guest for career guidance

Arrangement of Industrial Visit for Students

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Investigators

Large No. of specialists in different therapy segments

Medical Training In English : PG training from Europe/US

600,000 Eng. Speaking physicians

Large no. of ICH/GCP compliant Investigators / sites

Patient population

Large and diverse patient pool

Advantage of having 6 out of 7 genetic varieties

Large pt. pool in acute/chronic disease segment

Increasing no. of patients in life style disorders segment, HIV, Oncology

Central lab facilities (Internationally, Nationally accredited).

Regulatory prospective

ICH/GCP guidelines implementation.

USFDA/DCGI/ICMR: Regulatory guidelines and government policies helping

clinical research in India.

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GCP trained Principal Investigator bank and Research Network

Collaboration with Hospitals: Good quality infrastructure

Patient Pool: Trial patients with own healthy volunteer database

Integrated Approach & Expertise

Qualified and skilled professionals

Time and cost effectiveness

Quality management system

Data confidentiality

Fully validated 21 CFR Part 11 compliant database

Regulatory compliance at every step

Quality deliverables

Quick and efficient processes

Investigations & Sample Storage facility

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Mumbai, Navi Mumbai

Thane

Pune

Nashik

Aurangabad

Dhule

Nagpur

Goa

Ahmedabad

Vadodara

Jaipur

Raipur

Mysore

Thiruvananthapuram

Kolkata

Bhopal

Mangalore

Aligarh

Karnal

Chandigarh

Lucknow, Azamgarh, Varansi.

Surat

Delhi

Chennai

Bangalore

Hyderabad

Our Network in India

We have an expanding network of dedicated, experienced, GCP trained, and

quality conscious investigators throughout India.

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Wet/Dry granulation upto 5 kg batch size.

Drug layering and/or polymer coating of multiparticulates (Pellets)- Upto 1

kg batch.

Pelletization using extruder spheronizer- Upto 5 kg batch size.

Tablet compression upto 5-10 kg batch.

Qualty control tests for tablets (Precompression/ postcompression)

Stability testing as per ICH guidelines.

Formulation analysis using HPLC.

Spray drying of material- upto 1 kg batch size.

Quality control testing of packaging materials.

Development of nanoparticles using high pressure homogenizer.

Formulation & evaluation of semisolid dosage forms.

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We provide following type of services:

Anti-inflammatory

Anti-arthritic

Anti-fertility

Anti asthmatic

Immunomodulator

Kidney stone

Anti-hypertensive

Anti-diabetic

Neuropathic pain

Behavioural studies

Toxicities Studies: Acute/ Sub acute/ Chronic / Reproductive Toxicity/ Genotoxicity

Special Toxicity Studies:

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Decision to place a clinical trial

HCR

Research

Balance

Cost

Speed Quality

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Anesthesiology

Cardiovascular Diseases

Critical Care Medicine

Dermatology

Endocrinology

Gastroenterology

Geriatric Medicine

Gynecological Oncology

Oncology

Nephrology

Neurology

Obstetrics & Gynecology

Ophthalmology

Orthopedic Pediatrics

Pulmonary Disease

Urology

Internal Medicine

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Office Address:

LALIT GORE

Human Care research Pvt. Ltd.

Plot No 201, A wing,Daffodil Apartment,

Near Lal chowki,

Kalyan (w)-421301

Thane (Maharashtra) (India) : 9271250403/9867929416/9833508963

[email protected] , [email protected] ,

[email protected]

www.humancareresearch.com

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Site Address:

Human Care research Pvt. Ltd.

Dr. Deshpande’s

ASHIRWAD HOSPITAL

Maratha Section, Near Jijamata Udyan

Ulhasnagar-421004

Dist Thane (Maharashtra) (India)

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LALIT GORE