BPS Pharmacovigilance-services
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Pharmacovigilance Services Business Process Services Following the recent withdrawals of many blockbuster drugs, Pharmacovigilance has become a critical phase in the Clinical Development Programs of pharmaceutical companies. The regulations on safety monitoring have become stringent and are periodically revised. This has led to increased safety data collection, analysis, and regulations, which in turn has increased costs. You, therefore, need a strategic partner with process expertise – one who can minimize your cost pressures while unlocking value and maintaining compliance. We, at Tata Consultancy Services (TCS), are a market leader in providing drug development services to global pharmaceutical companies – with Pharmacovigilance Services being a core offering. We believe that Pharmacovigilance is a continuous process that has to be conducted throughout the lifecycle of a product. Effective pharmacovigilance function can often mean the difference between having a drug withdrawn from the market and having it stay. Hence it is critical for you to partner with a right service provider. Overview Backed by our extensive knowledge of the drug development process and domain expertise, we bring you comprehensive Pharmacovigilance Services. TCS can help you consolidate your global Pharmacovigilance operations and set up a dedicated team of qualified and experienced associates that help you ensure regulatory compliance, enhance your efficiency, and significantly reduce cost. We offer complete Pharmacovigilance Services, which include data collection, processing, medical review, safety writing, report writing, reporting, signal detection, and analysis. At TCS, we work in a partnership model, where you benefit from our domain knowledge, global reach, quality systems approach, multidisciplinary safety expertise and adhering to reporting timelines of EMEA, FDA, MHRA, and other regulatory authorities. Experience Certainty Experience Partnership TCS has gained expertise, set up robust processes and developed global infrastructure by providing world-class Pharmacovigilance Services to 4 of the Top 12 Global Pharmaceutical Companies. n Experience Results 550 + FTE's providing end-to-end Pharmacovigilance Services across a broad range of Therapeutic Areas across all phases of clinical development. Consistently met more than 99% compliance to regulatory reporting timelines. Up to 10 % reduction in error rate and increase in percentage accuracy by implementing Six Sigma projects resulting in increase in the number of cases handled per person per day. The TCS Advantage Industry domain expertise. TCS has acquired a thorough understanding of the Drug Development process with the experience of working for 9 of the Top 20 Global Pharmaceutical Companies delivering Clinical Research Services likes CDM, Biostatistics, Medical Writing & Publishing, Regulatory Affairs and Pharmacovigilance with 1,500+ highly skilled associates. We have experience of delivering end-to-end Pharmacovigilance Services and processing more than 450,000 cases right from Case Initiation, Triage & Processing, Medical Review, Safety Writing and Reporting. We also have the expertise in processing medico-legal and litigation cases. We have a delivery team comprising associates with extensive experience across different therapeutic areas and safety databases. n n n
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Transcript of BPS Pharmacovigilance-services
Pharmacovigilance Services
Business Process Services
Following the recent withdrawals of many blockbuster drugs, Pharmacovigilance has become a critical phase in the Clinical Development Programs of pharmaceutical companies. The regulations on safety monitoring have become stringent and are periodically revised. This has led to increased safety data collection, analysis, and regulations, which in turn has increased costs. You, therefore, need a strategic partner with process expertise – one who can minimize your cost pressures while unlocking value and maintaining compliance.
We, at Tata Consultancy Services (TCS), are a market leader in providing drug development services to global pharmaceutical companies – with Pharmacovigilance Services being a core offering. We believe that Pharmacovigilance is a continuous process that has to be conducted throughout the lifecycle of a product. Effective pharmacovigilance function can often mean the difference between having a drug withdrawn from the market and having it stay. Hence it is critical for you to partner with a right service provider.
Overview
Backed by our extensive knowledge of the drug development process and domain expertise, we bring you comprehensive Pharmacovigilance Services. TCS can help you consolidate your global Pharmacovigilance operations and set up a dedicated team of qualified and experienced associates that help you ensure regulatory compliance, enhance your efficiency, and significantly reduce cost.
We offer complete Pharmacovigilance Services, which include data collection, processing, medical review, safety writing, report writing, reporting, signal detection, and analysis. At TCS, we work in a partnership model, where you benefit from our domain knowledge, global reach, quality systems approach, multidisciplinary safety expertise and adhering to reporting timelines of EMEA, FDA, MHRA, and other regulatory authorities.
Experience Certainty
Experience Partnership
TCS has gained expertise, set up robust processes and developed global infrastructure by providing world-class Pharmacovigilance Services to 4 of the Top 12 Global Pharmaceutical Companies.
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Experience Results
550 + FTE's providing end-to-end Pharmacovigilance Services across a broad range of Therapeutic Areas across all phases of clinical development.
Consistently met more than 99% compliance to regulatory reporting timelines.
Up to 10 % reduction in error rate and increase in percentage accuracy by implementing Six Sigma projects resulting in increase in the number of cases handled per person per day.
The TCS Advantage
Industry domain expertise. TCS has acquired a thorough understanding of the Drug Development process with the experience of working for 9 of the Top 20 Global Pharmaceutical Companies delivering Clinical Research Services likes CDM, Biostatistics, Medical Writing & Publishing, Regulatory Affairs and Pharmacovigilance with 1,500+ highly skilled associates. We have experience of delivering end-to-end Pharmacovigilance Services and processing more than 450,000 cases right from Case Initiation, Triage & Processing, Medical Review, Safety Writing and Reporting. We also have the expertise in processing medico-legal and litigation cases. We have a delivery team comprising associates with extensive experience across different therapeutic areas and safety databases.
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All content / information present here is the exclusive property of Tata Consultancy Services Limited (TCS). The content / information contained here is correct at the time of publishing. No material from here may be copied, modified, reproduced, republished, uploaded, transmitted, posted or distributed in any form without prior written permission from TCS. Unauthorized use of the content / information appearing here may violate copyright,
trademark and other applicable laws, and could result in criminal or civil penalties. Copyright © 2013 Tata Consultancy Services Limited
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About Tata Consultancy Services Ltd (TCS)
www.tcs.com
Tata Consultancy Services is an IT services, consulting and business solutions organization that delivers real results to global business, ensuring a level of certainty no other firm can match. TCS offers a consulting-led, integrated portfolio of IT and IT-enabled infrastructure, engineering and assurance services. This is delivered
TMthrough its unique Global Network Delivery Model , recognized as the benchmark of excellence in software development. A part of the Tata Group, India’s largest industrial conglomerate, TCS has a global footprint and is listed on the National Stock Exchange and Bombay Stock Exchange in India.
For more information, visit us at
Delivery excellence. TCS has successfully undergone audits from FDA & MHRA. The independent internal quality assurance group performs internal GCP audits and is responsible for maintaining regulatory (ICH GCP) compliance within TCS, as well as prepares the study and process to be Audit ready. All our associates are well trained with in-depth knowledge and extensive experience in working on regulatory guidelines like ICH GCP, FDA. TCS has developed and implemented the Integrated Quality Management System (iQMS) to all clients to address all quality assurance practices.
About TCS Business Process Services (BPS)
Business Process Services (BPS) at TCS is about managing & executing business operations. Our domain expertise helps deliver core business processing across industries, analytics & insights and support processes such as accounting, HR and supply chain management. TCS partners with customers to accelerate co transformation, and generates business value for customers through delivery excellence, risk management and through innovative models such as Platform BPS which delivers process as a service. With annual BPO revenues of greater than US$ 1.4 billion, TCS is one of the largest BPS providers with 47,500+ employees servicing 225+ customers across the globe.
Contact
To know more about Pharmacovigilance Services, contact [email protected]
website link – www.tcs.com/clinicalresearch
Complete Pharmacovigilance Services
DATA COLLECTION & PROCESSING
MEDICAL REVIEW SAFETY WRITING SIGNAL DETECTION & ANALYSIS
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Receive cases from various sources
Case Initiation
Triage
Data Entry, Coding, Labeling
Narrative Writing
Quality Check
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Review source documentation
Confirm Seriousness
Confirm Expectedness
Review & Modify comments
Identify SUSAR/SUA’s
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Template selection
Review source data
Scientific/Medical Assessment of case
Authoring of first draft
Client review
Editorial review
Publishing
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Signal Generation and Detection
Signal Analysis
Determination of causality
Evaluation of frequency & strength
Determination of health outcomes
Experience working with ARISg, Argus Safety, Proprietary Client systems
An overview of our Pharmacovigilance Services
