Mar 28, 2023 | Case studies

Compliant drug safety framework for early phase clinical trials

A biotech had successfully completed Phase I clinical trials and was rapidly progressing into Phase II. Serious adverse event (SAE) volume was expected to significantly increase and therefore associated workload could not be managed in-house.
Qinecsa established a compliant and robust drug safety framework in line with budget and quality expectations to manage increased case volumes.

Resources

Join Qinecsa at 32nd Pharmacovigilance 2023, 26-27 April, Boston

Join Qinecsa at 32nd Pharmacovigilance 2023, 26-27 April, Boston

Join Qinecsa at 32nd Pharmacovigilance 2023 to discuss the latest developments in pharmacovigilance, drug safety & risk management.Our President, Humaira Qureshi, will present ‘Fit for future sourcing for pharmacovigilance’ where she will discuss the drivers for...

Signal & risk management

Signal & risk management

Qinecsa provides tailored signal detection and risk management services for clinical and commercial products, including associated benefit-risk management activities. With diverse therapeutic expertise and industry-leading technology, our team support the breadth and...

CVW platform

CVW platform

The Commonwealth Vigilance Workbench (CVW) signal detection platform spans the full spectrum of the signal management process to ensure all potential signals are tracked with clear prioritization. Robust data integration and functionality enables analysis of aggregate...