By PBR Staff Writer
Pharmaceutical Business Review - April 23, 2013
Aptalis Pharma has deployed TransPerfect Trial Interactive as its global pharmacovigilance system master file (PSMF) technology.
The Trial Interactive PSMF technology is compliant with the legal requirements as outlined in the Commission Implementing Regulation and as detailed in GVP Module II.
TransPerfect will offer Trial Interactive PSMF for all of Aptalis' products in the European Union.
Aptalis global pharmacovigilance senior director Catherine Godefroy said, "A solution like Trial Interactive is designed to allow near real-time access to global pharmacovigilance stakeholders and regulatory authorities."
TransPerfect life sciences solutions division general manager Michael Smyth said, "Many pharmaceutical companies and contract research organizations (CROs) are already using Trial Interactive's electronic trial master file (eTMF) and Study Start Up module to streamline clinical development in a paperless environment."