Since 1997, PSI has continuously performed MedDRA coding/classification of
individual safety reports for the FDA. We have processed on the average 5,000
safety reports weekly, exceeding 3.5 million to date. Over the years, we have also supported multiple pharmaceutical clients and other government organizations, coding over
10 million verbatim terms.
PSI has an experienced pool of MedDRA coding experts. Our coding methodology employs a three-tiered, physician-based quality assurance process in which all coded terms are reviewed to ensure medical accuracy, consistency and adherence to customer coding standards and guidelines. We understand the unique requirements of supporting both pre- and post-marketing environments. Our processes and the clinical experience of our coding staff enable us to code with high quality, to asses each verbatim term and provide queries for those which necessitate further clarification by the investigator, and to recommend VTA additions to the client's Synonym table.
PSI has assisted our clients both remotely and on-site. We are ready to receive and code your data in our 21 CFR Part 11 compliant Coding System, or to work through remote access in your thesaurus system. We are also ready to temporarily join your internal coding team on-site and serve as a colleague and a mentor.
PSI is also experienced in upversioning previously coded data and providing version impact reports. We also provide Synonym table maintenance services to further ensure long-term coding accuracy and consistency.