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Industry
Life Sciences
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Patient-centered Care Models Taking Center Stage in Life Sciences
Read how patient-centric care models and pharma innovation are ushering new trends in life sciences to improve patient outcomes and enrich lives.
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Learn how an integrated approach to packaging, artwork, and labeling management can effectively and efficiently manage the process and improve pharma compliance.
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23 Dec 2024
At the TCS Pace Port™, leaders explored the immense potential of AI and generative AI in the pharma industry during the Life Sciences Forum event. Learn more.
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02 Dec 2024
With EU MDR’s deadline extension, medtech manufacturers can leverage next-gen technologies and build on connected, collaborative, and cognitive value chains.
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29 Nov 2024
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TCS ADD™
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TCS ADD™: A Suite of Modern and Open Technology Platforms
TCS ADD™ is a suite of modern and open technology platforms for clinical research and drug development that helps make clinical trials more agile and safe.
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This paper highlights challenges in data transfer agreement and demonstrates how the proposed e-DTA solution can transform the clinical trial industry.
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18 Dec 2024
Engage with our experts at the World Drug Safety Congress Americas 2024 to learn about AI in pharmacovigilance and our TCS ADD™ Safety platform. Join us now.
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09 Sep 2024
Join us at the life sciences event to learn how AI and generative AI can accelerate next-gen clinical R&D and enhance patient safety. Register now for the event.
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07 Aug 2024
Automating third-party data transfer through digitized electronic data transfer agreements (DTA)
Clinical data management (CDM) is a pivotal process in clinical trials with data directly captured into case report forms (CRFs). However, a large portion is also collected from external sources like third-party vendors, labs, wearables, devices, and external systems. Titled ‘non-CRF data’, there is a need to maintain data integrity and quality of this data as it bears a critical influence on the clinical data management process and study success.
To ingest non-CRF data from external third parties, data transfer agreements (DTA) are signed between sponsor and vendor organizations. DTA defines the structure, frequency/ timelines, and data definitions that enable the transfer of non-CRF data from the vendor to the study database. The DTA authoring and review process is time-consuming, and reconciling non-CRF data with the CRF data also takes time due to associated quality—and standard-related issues with the non-CRF data.
An online, collaborative, highly automated, and real-time DTA authoring solution, along with an integrated multi-step DTA review and approval system, can significantly benefit the non-CRF data management landscape. The system can utilize predefined master DTA templates, data models, and code lists to automatically draft the DTA document. Multiple editors can view and edit the auto-generated DTA document in real-time. Once the edits are reviewed and finalized, an approver can approve the DTA and an eSignature.
Currently, though most clinical trial management systems have connectors or interfaces that enable them to seamlessly receive non-CRF data from external labs and vendors without manual intervention, the data remains non-standardized and unstructured. To maintain data quality and integrity, the vendor and the study sponsor need to sign an agreement on the data transfer specifications.
A new approach to managing DTA and third-party data utilizes template-driven, AI-powered automatic e-DTA document creation. These documents can then be collaboratively edited and reviewed by multiple editors and reviewers in real time.
The proposed e-DTA solution can leverage AI/ML to extract metadata from protocol documents and use standardized templates to automatically generate DTA documents, providing a robust collaborative authoring, review, approval, and digital signature workflow. This method can solve most of the problems the clinical trial industry is facing in managing data transfer agreements.
To read the complete paper, please visit PharmaSUG-2024-MM-447.pdf.
About the authors
Image of Vandita Tripathi
Vandita Tripathi
Vandita Tripathi is the Product and Portfolio Head for TCS ADD™, part of TCS's Life Sciences unit.
Image of Manas Saha
Manas Saha
Manas is a .NET and Azure architect and Technical Lead with 16+ years of experience developing and designing software solutions using Microsoft technologies.
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