Are You Prepared to Replace the Thorough QT Study?
June 15th 2016An updated release to the ICH E14 Guidance could indicate that data be used to replace a TQT trial for regulatory submission and review. The result of such a change would be a reduction in development time and costs for biopharma companies.
Modern Pharmacovigilance: Are Pharma Companies in Control of Their Processes?
June 13th 2016A recent survey found that sponsors do not have the required metrics to properly assess their operational activities related to drug safety reporting. Applying capture technology is one way to better measure these processes and ensure consistent data quality for medical evaluation.
Preparing for the ICH E6 (R2) Addendum: A 3-Part Series
June 13th 2016This 3-part series provides insight into ensuring compliance with the ICH E6 (R2) Addendum to take effect later this year. Part 2 covers steps that organizations can take today to begin adopting a centralized technology-based approach to risk management.