The industry is currently in a period of unprecedented transformation, driven by ongoing shifts in the regulatory sphere from document-driven to data-driven information management. This transition is certain to continue well into the next decade and poses a significant challenge to the industry, with profound impact on how we manage regulatory information going forward.Read More
Are your practices for handling TMFs compliant with the new GCP requirements from ICH E6 (R2) coming into effect June 14?
Background for ICH E6 (R2)
The ICH GCP E6 regulation was introduced in 1996 when clinical trials were largely run on paper. Since then, the following trends have significantly increased:• the scale, complexity, and cost of clinical trials • the degree of outsourcing for... Read More