GCP Change – New Risks for Biotech?

Going Public Biotechnology Magazine p.76-77

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 Artem Andrianov, Ph.D., MBA|2020-09-23T09:47:02+02:00September 21, 2015|News|0 Comments

About the Author: Artem Andrianov, Ph.D., MBA

Professional in the integration of data-driven Risk-based Quality Management (RBQM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, Health 2.0, DGGF, etc. 18+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RBQM research to new frontiers for CROs, pharma and biotech companies.