Launched at DIA Europe last week, the solution was received positively, said Quintin Van Wyk, VP of pharmacovigilance and safety reporting at Icon.
“Sponsors are especially interested in the capability to integrate with other clinical trial applications for increased efficiency and the opportunity decrease complexity in the process,” he told us.
Wyk said the new cloud-based solution features automated and configurable business rules to distribute “expedited and periodic submissions to all stakeholders,” including investigator sites, ethics committees, institutional review boards, and competent authorities.
The system verifies and translates pharmacovigilance regulatory requirements for 80 countries into date-stamped reporting rules to track changing requirements. It also is integrated with Icon’s electronic trial master file (eTMF) for automated filing and provides an auditable distribution trail, among other features that aim to reduce time and effort for study personnel, said Wyk.
“Drug safety reporting is complex due to the evolving, ever-changing regulatory environment,” he explained. “Running a clinical study across multiple countries requires careful consideration of global and national country legal pharmacovigilance requirements.”
Wyk noted that it is crucial to stay current with the latest developments, adapting reporting to the required format and deadlines.
“One country or region may have numerous regulations, directives, laws, guidance and these rules may have overlapping or contradictory requirements,” he added. “Appropriate interpretation of pharmacovigilance regulations requires in-depth knowledge of both global and local regulations to decipher the reporting rules and avoid over or under reporting that might affect patient safety.”
