GCP Change – New Risks for Biotech?

 Going Public Biotechnology Magazine p.76-77
Going Public Biotechnology

The new upcoming GCP E6(R2) addendum reforms clinical monitoring and clinical trial management. Risk factors are an important component. What this means for a biotech company: clinical trial risks are easy to foresee, site level risks and operational risks are hard to detect; in this article, you will find a step by step approach to how to turn the new regulation to your best advantage.
By Artem Andrianov, PhD




See more in the article in Going Public Biotechnology magazine, p.76-77.

By |2016-11-16T18:35:43+00:00September 21, 2015|Library, News|0 Comments

About the Author:

Professional in the integration of data-driven Risk-based Monitoring (RbM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, PharmaForum, PharmaDay, DGGF, etc. 10+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RbM research to new frontiers for CROs, pharma and biotech companies.

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