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Introducing Next Generation Digital TMF (dTMF) Services from Syntel
Sponsors need to ensure that their trial dossiers are regulatory compliant and always inspection and submission ready. Now, Syntel has pioneered a new digital approach to manage, modernize and automate global Trial Master File (TMF) operations with process automation, reference models, CRO collaboration and digital solutions to ensure high quality trial documentation.
Syntel’s Digital TMF (dTMF) solution is designed as a managed service to ensure your clinical trial dossiers are always compliant, consistent and complete – enabling you to bring life savings drugs to market faster. Through an intelligent automation approach, we manage, modernize and streamline your global clinical operations and transform core business services to deliver increased productivity, cost and time savings.
Syntel services and solutions meet FDA, MHRA and EMA audit requirements. Our extensive knowledge of ICH E6 guidelines, the DIA reference model and 21 CFR Part 11 requirements allow us to support your audit and inspection needs, and our automated solutions mean we can handle any volume requests driven by your changing business needs.
The client, a top 10 global pharmaceutical company engaged Syntel to provide end-to-end Trial Master File (TMF) services. Later, as the document inventory increased, they began to face issues such as decentralized processes and a high level of inefficient manual work. They asked Syntel to explore how the TMF process could be automated through the SyntBots intelligent automation platform.download PDF