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.
Avoid Shortcuts on Route to Data Anonymization
June 3rd 2016Faced with new EMA guidance on anonymizing clinical trial data, drug manufacturers have two choices – do what it takes to meet the November deadline and prioritize clinical study reports, or embrace a more sustainable strategy that starts with the patient-level data.
A New Approach to an Old Problem – Speeding Study Startup
June 2nd 2016While launching a new clinical study is an exciting stage of product development for trial personnel, road blocks can emerge. A new approach is needed to cope with the volume of activates required for the study product registration.