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.