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 […]

Cost-effective drug safety systems and solutions

A small pharma client with limited budget had several clinical compounds in Phase I and II, and one globally approved commercial product. They required robust processes for the evaluation of single and aggregate data to strengthen stakeholder review and documentation management associated with serious adverse events (SAEs).

Developing a robust drug safety framework

A small biotech with a healthy development pipeline had no internal pharmacovigilance expertise. They required a compliant drug safety framework to support safety data collection, evaluation, and dissemination during clinical trials. Qinecsa established a simple, compliant drug safety framework, including a suite of policies and procedures in line with relevant legislation, to support collection, evaluation, […]