ArisGlobal

Clinical Trial Disclosure: What It Takes to Achieve an Efficient and High-Quality Process


The goal of fostering greater public trust and confidence in the clinical trial process has resulted in ClinicalTrials.gov and EudraCT leading the growing list of trial registries. Yet the disclosure and compliance process has increased the workload for biotech, medical device and pharmaceutical companies.

Many sponsors find it difficult to manage trial registrations worldwide given their limitations in staff and budget. Manual, labor-intensive processes exacerbate the challenge as the consistency of data is prone to human-error. Constant changes in the regulatory environment and the emergence of new registries make it even more difficult to maintain high quality data and stay on top of current regulations.

In this 45-minute topic webinar, learn how your regulatory affairs and trial disclosure team can achieve an efficient, high-quality process. Listeners will learn the major differences between ClinicalTrials.gov and EudraCT, the importance of the source of the data to be published, how to achieve an efficient and fast disclosure process, and latest changes in the regulations and registries.

 

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