Strategic Alliance with Global Specimen Solutions: Introducing Covance SpecimINSIGHT™

The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – such as genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop the central challenge facing trial sponsors remains the same: the …

TQT Waivers: One Year Later

Overcoming Design Challenges ICH E14 REGULATORY GUIDANCE 2005 AND 2015 It has been one year since the International Conference on Harmonisation (ICH) updated its 2005 cardiac safety guidelines. The 2015 update allows for specific QT interval analysis based upon concentration effect modeling up to supratherapeutic during Phase I as a …

Risk-Based Monitoring – Driving the Evolution of the Clinical Research Associate Role

Over the last 10 years, clinical trials have changed substantially in response to increasing globalization and study complexity, along with new technological capabilities and industry guidelines[1],7. With these noticeable transformations, sponsors are increasingly revisiting their monitoring methods to uncover new efficiencies and develop more robust risk management processes that can enhance …