The new ICH GCP E6(R3) guidance, effective July 2025, signals a significant shift towards more flexible, patient-centered and ...

Sponsors of clinical trials can now easily perform an independent check of the data quality coming in from sites at any time, contribute to a risk-based approach to monitoring and check follow-up by ...

On June 11, 2015, the International Conference on Harmonization released the draft update of Good Clinical Practice guidelines. The proposed R2 addendums are a significant update and feature important ...

As new ICH GCP draft guidelines now require root cause analysis, novel methods for risk analysis and triage must be adopted in drug development. Decades ago, a study would typically be performed by a ...

Overview: The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately ...

The common practice is to document the eligibility criteria in the CRF by ticking the question: Did the subject satisfy all study entry criteria? with 'yes'. However, this is not adequate for ...

When applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH ...

The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications. As the world’s economy is increasingly threatened by new barriers to trade, the ...