Article | September 17, 2019

An Overview Of TMF Oversight—Part 1: Keeping An Eye On Your Vendors

Source: TransPerfect

By Laurel-Ann Schrader, Director, Advisory Services, TransPerfect Life Sciences


Conducting clinical trials is an intense exercise in risk management. From patient safety to regulatory scrutiny to every dollar of investment, risks are plentiful and threaten the successful delivery of potentially life-saving therapeutics. Like many business challenges, risk management comes down to an organization’s approach to oversight to provide the right mechanisms for accountability and to ensure the sponsor is aware of what’s happening across all aspects of operations. This bears repeating: Sponsors, you must have a means to access the activity taking place in your TMF, in your investigator site files, at your investigative sites…everywhere.

For part 1 of our oversight series, let’s talk vendors. Ensuring quality assessment and review processes are in place is essential. Getting all of that correct means starting out on the right foot.


Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Clinical Leader