Theorem Clinical Research Releases Booklets to Provide ICH GCP Guidance for In-Vitro and Investigational Product Trials  
2/27/2013 11:08:20 AM

KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Theorem Clinical Research has released two site-level reference booklets for clinical research sites that explain and condense critical International Conference on Harmonisation guidelines related to Good Clinical Practice for the conduct of trials.

Authored by Judith Köhnen and Lee Spurgin, PhD, “Little Advisor ICH GCP for Investigational Product Trials” explains key concepts of the ICH GCP requirements. Their second book, “Little Advisor ICH GCP for In Vitro Diagnostic Trials,” provides guidance on regulations specific to trials involving in vitro diagnostic devices. Both are available for purchase online.