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May 2016

Data from Global RACT Analysis Reveals Subjectivity

By | May 11, 2016|Library, News|0 Comments

What are the most common risks in clinical trials? What challenges faces TransCelerate RACT? Read the answers in the latest article published on ACT. by Moe Alsumidaie, Beat Widler, PhD, Peter Schiemann, PhD, Artem Andrianov, PhD Do you want to know about @RACT more and start using [...]

Sep 2015

GCP Change – New Risks for Biotech?

By | September 21, 2015|Library, News|0 Comments

 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 [...]

Aug 2015

Quality Risk Management as a Survival Kit

By | August 26, 2015|Library|0 Comments

From Idea to Implementation (by Randy Ramin-Wright and Artem Andrianov) DIA Global Forum: Efficient risk management becomes more than advice today, it becomes part of a survival kit for a modern pharmaceutical company. Due to increasing trial complexity, regulatory scrutiny, competition for patients and high [...]

May 2015

ICH Goes Risk-Based

By | May 26, 2015|Library|0 Comments

ICH GCP Goes Risk-Based GCP Addendum Review and Embracement Plan by Artem Andrianov, PhD, Beat Widler, PhD, Maria Proupín-Pérez, PhD Web-View AppliedClinicalTrials, May 2015: The new upcoming GCP E6 (R2) addendum has the potential to reform clinical monitoring and clinical trial management. What changes [...]