Case Study

Preparing Data Packages For Regulatory Submission

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In March 2020, proinnovera GmbH, a dermatology-specialized European CRO, joined forces with OCT Clinical’s team to carry out interim statistical analysis in its study on seven subjects and prepare necessary data packages. The database lock was performed in September, and by October OCT had successfully completed all assigned tasks and delivered all required data packages. The primary goal of the study is to evaluate the safety and pharmacokinetic profile of the studied medical product’s active ingredients and their metabolites after its application.

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