Thomas Wicks is chief strategy officer TrialScope. He has more than 20 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling and submissions management. A frequent contributor to industry publications and speaker at industry events, he has been on focused on trial transparency since 2007.
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Most clinical trial sponsors view data disclosure as a mandate, maintaining regulatory compliance as a legal requirement. Study sponsors that realize the potential to repurpose this data, using a patient-first approach, turn transparency into a strategic advantage for engagement and recruitment efforts.
Clinical trial disclosure compliance must include identification and documentation of registry requirements, key stakeholders, company policies, systems, and processes.
Robust transparency, and perhaps even just compliance with evolving requirements of multiple regulators, requires commitment from the C-suite for companies of all sizes.
Potential fallout from noncompliance goes well beyond regulatory penalties; adherence has improved but less so for smaller companies.