PubHive Upgrades SaaS Platform to MedDRA Version 25.1

October 31, 2022

PubHive Ltd., a cloud-based software company, 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 25.1 that was released in September 2022.  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).

 

“The integration of MedDRA into the PubHive Navigator platform is just one of the many ways that our SaaS platform saves time for drug safety and pharmacovigilance teams, effectively reducing the number of safety system interfaces and process steps that are required to perform their safety evaluation, risk management, and aggregate safety reporting activities,” said Raj Vaghela, President and CEO at PubHive. “Our growing base of DSPV users can count on PubHive to ensure that they always have access to the most current version of MedDRA via our platform so they can perform their work accurately, while getting the most value from their MedDRA subscription license.”

 

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 March 2022 MedDRA Version 25.0 to the September 2022 MedDRA Version 25.1, included: terminology changes, additional COVID-19 related terms, standardized MedDRA queries (SMQs), Proactivity requests, new MedDRA languages deployed and under development, and a MedDRA self-service application update. 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 a mission to make healthier scientific literature and safety workflows for life science companies across all stages of the commercialization lifecycle – from discovery to post-market. PubHive Navigator™. The company’s scientific literature 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, regulatory, information management, and other divisions. PubHive Navigator’s safety and vigilance platform module Pulse features powerful workflow and information management capabilities for scientific literature, aggregate safety reporting, signal management, and more.

 

To learn more about PubHive and the PubHive Navigator platform, visit the company’s website at pubhive.com.

 

About PubHive

PubHive Ltd. is a cloud-based software company with a mission to make healthier literature and scientific 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, 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 management platform today, distinguishing itself through flexible end-to-end workstreams and intuitive interfaces that make literature handling quick and easy.