Aggregate reporting is a vital tool to monitor the benefit/risk balance throughout a medicinal product’s lifecycle. The timeline, frequency and exact type of aggregate report required for submission vary amongst the drug regulatory agencies worldwide. In addition to the submission of individual case safety reports, companies are required to periodically review cumulative safety information from various sources, including clinical trial results and spontaneous cases, and submit any findings as aggregate reports to regulators. One type of post-marketing aggregate report is the Periodic Adverse Drug Experience Report (PADER) in the US. The FDA requires PADER submission quarterly for the first 3 years following the US approval date and annually thereafter and mandates specific information in the reports.
A multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, ophthalmology, neurology and branded generics was using another vendor for pharmacovigilance (PV) services. Due to ongoing quality issues, poor communication and poor project governance with their current vendor, the company approached Bioclinica for PV services, including aggregate reporting, focusing specifically on PADERs.
Recognizing the company’s urgent situation, during the one-month period between their selection as the preferred vendor and contract signing, Bioclinica gathered a dedicated project team of 15 expert resources in aggregate reporting based at the Bioclinica campus in Mysore, India. Each of the team members completed customized training and passed a rigorous evaluation to ensure familiarity with the company systems and processes.