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 J.P. Morgan Healthcare Conference 2024

Join Qinecsa at J.P. Morgan Healthcare Conference 2024

Qinecsa is on a mission to drive positive change in the pharmacovigilance industry. As we enter a new year with exciting plans to continue advancing pharmacovigilance solutions, we look forward to engaging with industry leaders and investors at the forefront of...

Quality & compliance

Quality & compliance

Qinecsa provide quality and compliance services to support clients in audit and inspection readiness, SOP writing, data privacy adherence, pharmacovigilance training, PSMF maintenance and CAPA management.

End-to-end case management

End-to-end case management

Qinecsa is a leading global provider of end-to-end pharmacovigilance solutions. Our team of pharmacovigilance specialists leverage technology solutions to deliver all aspects of global case management for both clinical and post-marketing products.