TCS Positioned as a Leader in Pharmacovigilance and Complaint Management Operations by Everest Group

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TCS Positioned as a Leader in Pharmacovigilance and Complaint Management Operations by Everest Group. Tata Consultancy Services (TCS) (BSE: 532540, NSE: TCS), a leading global IT services, consulting and business solutions organization, has been positioned as a Leader in the Everest Group PEAK Matrix® for Pharmacovigilance (PV) and Complaint Management Operations[1].

In an assessment of 22 PV and complaint management service providers, TCS was placed highest for Vision and Capability. According to the report, TCS is one of the fastest growing service providers within the pharmacovigilance market, and has accumulated significant scale across the pharmacovigilance value chain, including individual case study report (ICSR) case processing, literature screening, regulatory submission, aggregate reporting, and signal and risk management.

The report cites TCS’ strong capabilities to serve enterprises in both clinical trial drug candidates and post-market surveillance products safety activities, as a key strength. It goes on to say that the company has made significant investments in technology to augment its services – leveraging cognitive automation for case processing and offering the TCS Advanced Drug Development (ADD) PV platform-driven services to its clientele.

Life Sciences companies are investing in next-gen technologies to ensure patient safety and comply with evolving regulatory norms. TCS complements its pharmacovigilance services with deep medical and regulatory domain expertise and use of advanced technologies such as automation, AI and machine learning to help customers meet business and regulatory requirements effectively and efficiently,” said Vikas Jain, Business Unit Head – UK & Europe, Life Sciences, TCS. “This leadership positioning by Everest is a reflection of our strong vision, capabilities, innovation efforts and the resultant market success.”

TCS partners with leading life sciences companies and provides clinical research services such as clinical data management, regulatory affairs, PV, risk-based monitoring, biostatistics and programming, and medical writing and publishing.

Within pharmacovigilance, TCS offers end-to-end integrated safety services including ICSR case processing, signal detection, risk management, local affiliate activities, PV analytics and applications, literature surveillance, aggregate/ regulatory reporting, clinical evaluation reports, medical safety assessment, and other pharmacovigilance support activities.

TCS ADD Safety reimagines pharmacovigilance by applying machine vision, artificial intelligence, smart analytics and IoT to automate the intake, processing and analysis of safety cases. The platform significantly reduces the time taken to process safety cases and increases throughput with consistently high levels of accuracy.

In the complaint management space, TCS’ services span intake processing, complaint mailbox management, triaging, complaint coding, product investigation, complaint review, complaint approval and closure, customer communication, warranty claim processing, regulatory reporting, product return tracking, and CAPA management.

TCS has over 15 years of experience handing device complaints of various severities and numerous product categories right from implants, surgical devices, surgical aiding devices, to diagnostic devices and lab equipment.

The life sciences industry is betting big on leveraging advanced technologies across drug/device safety processes to increase operational efficiency and accuracy,” said Manu Aggarwal, Vice President, Everest Group. “TCS is one of the few service providers that not only offers end-to-end pharmacovigilance and complaint management services, deep domain expertise, and sizable operations but also differentiates itself in the market by deploying cognitive automation via its ADD Safety platform to increase efficiency and reduce manual effort for its clients.”

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