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Future Clinical Trial Documentation: eTMF and Blockchain Integration

Adopting the next-generation, blockchain-based eTMF systems

Saurabh Das

Head, Research & Innovation, TCS ADD Platforms

Ashutosh Pachisia

Scientist, LSHCPSER, Big Data

Rohit Kadam

Researcher, LSHCPSER, Pharma IT Solutions & Innovation

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The rapid expansion of clinical research requires modern clinical trials to be reliable. However, the current electronic trial master file (eTMF) solutions using traditional databases are fraught with severe drawbacks such as unreliability, imperfection, inaccuracy in version traceability, and redundancy of data. Clinical trial data is growing rapidly, and with these issues being unchecked, there is a high probability that it will lead to a massive degradation in the performance of eTMF systems, thereby hampering the efficiency of the documentation process. Additionally, it is evident that blockchain-based decentralized storage can save a substantial amount of time and effort for any researcher involved in clinical trial documentation. The article highlights a potential solution that can serve as the basis for a new digital TMF that can address the challenges of the dynamic and ever-evolving clinical trial data.

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About the authors

Saurabh Das
Saurabh Das is part of Life Sciences, Advanced Drug Development (ADD) Platforms at Tata Consultancy Services (TCS). In his current role, he is the Product Manager of TCS' Pharmacovigilance Platform : Integrated Patient Safety. He has over 10 years of experience in product development and managing large program executions.
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Ashutosh Pachisia
Ashutosh Pachisia is a Data Scientist at Tata Consultancy Services (TCS). With nearly half a decade of experience in IT. He has a rich experience leading large complex programs and driving key initiatives for TCS Healthcare.
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Rohit Kadam
Rohit Kadam is a Researcher at Tata Consultancy Services (TCS). He is working with the TCS ADDTM Life Sciences Platform as a Researcher in R&I Team for nearly 2.5 years and contributed extensively in developing key solutions for TCS Healthcare Domain.
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