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Anonymization vs. Redaction of Clinical Trial Data
Anonymization vs. Redaction of Clinical Trial DataBlog

Anonymization vs. Redaction of Clinical Trial Data

January 17, 2025 The vernacular for disclosing pharmaceutical clinical trial results to the public may seem just as confusing as the process! Some people…
FAQs on Developing EMA Policy 0070 Submissions
FAQs on Developing EMA Policy 0070 SubmissionsBlog

FAQs on Developing EMA Policy 0070 Submissions

In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish all clinical studies submitted for…
How To Respond to Health Authority Questions  
How To Respond to Health Authority Questions  Blog

How To Respond to Health Authority Questions  

Your biotech company has just submitted the marketing application for your first drug product. It’s a moment of celebration after…
Why You Need an Integrated Development Plan
Why You Need an Integrated Development PlanBlog

Why You Need an Integrated Development Plan

Learn about the Integrated Development Plan for successful drug development & its relation to the Target Product Profile & Clinical…

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