Thursday, January 5, 2012

Clinical Regulatory Documents: Master of your TMF Domain

Partnerships In Clinical Trials 2012 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to this year's event.

TMF Today
By Swadesh Sharma

The Trial Master File (TMF) is the heart of every clinical trial. The TMF often paper/binder based is a collection of essential regulatory documents which are required to initiate a trial within an investigative site. Being paper/binder based on the site side, requires constant manual update and management. This may seem like a easy task to deal with when in actuality, it is the research staff who maintain and update the TMFs which take away from the researchers specialty of treating patients and managing protocol procedures.
The FDA form 1572 is the most redundant document received by the FDA. Redundancy in the realm of 220,000 – 240,000 per year. That equates to ~602-657 per calendar day AND almost 25 per hour! If the FDA is receiving this many to process and maintain, then clinical sites are under-resourced when adding to their tasks – treating patients, completing eCRFs, SAE Forms, responding to audits and other non-clinical trial aspects.

The maintenance and updating the TMF lends to much of the avoidable costs within clinical research. The unrecovered costs which are linked in the thousands of dollars lie in executing, recruiting and adhering to compliance. Lost dollars that can actually lead to an expedited method from discovery to doctor.

Closing Thoughts

By establishing a robust regulatory document and workflow process on the clinical site level, the clinical site can drive growth within their clinical research portfolio, reduce redundant clinical start-up time, centralize documents and increase availability of regulatory documents.

About the author
Swadesh Sharma is a 13 year professional in the Life Science industry working across a global CRO, start-up oncology niche CRO, international pharmaceutical and mid-sized pharmaceutical companies in the capacity of business development, project management and product pipeline strategy. Currently, Swadesh is leading site start-up activities in his current position evaluating streamlined processes and solutions including TurboRegs.
Folder Image above: Renjith Krishnan /

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