Drug safety and pharmacovigilance (DSPV) teams that license access to the PubHive Navigator platform can now access the newest MedDRA version when performing signal evaluation and reporting activities.
PubHive Ltd., a scientific software company serving enterprise life science companies, today announced that the company’s scientific workflow management platform has upgraded its integration of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH’s) Medical Dictionary for Regulatory Activities (MedDRA) to MedDRA version 26.0 that was released in March 2023. PubHive’s integration of the newest version of the standardized medical terminology dictionary-thesaurus enables PubHive Navigator™ platform users with one-stop access to perform MedDRA lookups in concert with the platform’s native capabilities for monitoring, detecting, evaluating, and reporting on product safety signals arising from individual case safety reports (ICSRs).
“MedDRA is one of the most important tools in the safety systems toolbox for drug safety and pharmacovigilance teams with applications throughout all phases of the development cycle, from clinical trials to post-market surveillance,” said Raj Vaghela, President and CEO at PubHive. “PubHive integrates access to MedDRA from directly within the PubHive Navigator DSPV software solution so our users can save time performing important SMQ lookups and standardized coding work related to post-market safety activities.”
Now used by more than 6,800 organizations from more than 125 countries, MedDRA is clinically validated for international use across in the registration, documentation, and safety monitoring of medicinal products through all phases of the development life cycle. The single standardized terminology eliminates the need to convert data from one terminology to another, improves data quality and timeliness, optimizes terminology consistency that allows for more effective analysis, and facilitates more efficient electronic exchange of data relating to medicinal products. MedDRA is a subscription-based product of the ICH and is maintained by the Maintenance and Support Services Organization (MSSO).
According to MSSO documentation, the changes from the September 2022 MedDRA Version 25.1 to the March 2023 MedDRA Version 26.0, included: terminology changes, complex changes, additional COVID-19 related terms, standardized MedDRA queries (SMQs), proactivity requests, new MedDRA languages deployed and under development, and a new set of MedDRA application program interfaces (APIs). Full MSSO documentation can be viewed on the official MedDRA website located online at www.meddra.org.
PubHive Ltd. is a cloud-based software company with the mission to make healthier scientific literature and safety information pathways for life science companies across all stages of the commercialization lifecycle – from discovery to post-market. PubHive Navigator™, the company’s scientific workflow management platform, optimizes existing business processes and automates repetitive work for life science companies. PubHive Navigator features platform modules for drug safety and pharmacovigilance activities, systematic literature review projects, and scientific literature workflows performed by teams in clinical and regulatory affairs, medical affairs, medical information, and discovery research.
To learn more about PubHive and the PubHive Navigator cloud software platform, visit the PubHive website at pubhive.com.
About PubHive
PubHive Ltd. is a cloud-based software company with a mission to make healthier scientific literature and safety information pathways for life science companies across all stages of the commercialization lifecycle – from discovery to post-market. PubHive Navigator, the company’s scientific workflow management platform, optimizes existing business processes and automates repetitive work for teams in drug safety and pharmacovigilance (DSPV), medical affairs, market access and health economics and outcomes research (HEOR), research and development, clinical affairs, regulatory affairs, information management, and other divisions. Powered by a proprietary Omni-Loop Artificial Intelligence (AI)™ engine, PubHive Navigator is the only 'fit for purpose' one-stop scientific workflow automation platform today, distinguishing itself through flexible end-to-end workstreams and intuitive interfaces that make literature handling quick and easy.