Challenges of 2020: Lessons for Clinical Trials in Diabetes

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Parexel Insights

Fostering steady advances in data operations: FSP partnerships can spur and support change

11.12.20 - 5 min - When we discuss innovation in clinical trials, it’s easy to think first of technologies involving digital health or evolving tools such as augmented intelligence. And these are certainly meaningful advancements.

The long and winding road for quality metrics takes another turn

11.09.20 - 4 min - In the latest turn of the long and winding road for quality metrics, FDA recently published invitations for industry to participate in two pilot programs for quality management maturity (QMM).

Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

10.23.20 - 9 min - This blog focuses on unpacking the important points made in the companion Guidance for Industry – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Druga and Cosmetic Act.

Early Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting

10.22.20 - 6 min - Despite the best efforts of the pandemic, the FDLI delayed but did not cancel its annual meeting for 2020 and hosted the event through a virtual platform. In this blog, I’ll walk through the points that resonated as nuggets of important new information.

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