PubHive Adds Aggregate Report Writing Interface to PV Software Platform

PubHive Ltd., a cloud-based software company, today announced the availability of a new aggregate report writing interface to safety scientists and other pharmacovigilance (PV) users via the company’s cloud-based scientific literature workflow platform.  The new interface enables users to write, save, edit, select templates and export aggregate reports, including previously screened literature, which must be submitted to regulatory authorities such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

“PubHive developed its new pharmacovigilance report writing interface in response to requests from our PV scientist platform users,” said Raj Vaghela, President and CEO at PubHive Ltd. “PubHive users value a centralized platform for all of their PV literature, literature reviews, and workstreams, and this new feature reinforces PubHive Navigator’s unique value proposition as a one-stop platform for end-to-end PV literature workflows.”

Aggregate reporting is a process for reviewing cumulative product safety information on a periodic basis and across numerous sources, including scientific literature.  Findings must be submitted to regulators in various countries and regions, focusing on delivering overviews, assessments of safety profiles and benefit-risk evaluations of adverse drug reactions (ADRs), adverse events (AEs), and serious adverse events (SAEs).  Post-marketing reports can include Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Safety Update Reports (PSUR), Periodic Adverse Drug Experience Reports (PADER), NDA and ANDA annual reports, and addendum to clinical overviews (ACO), while pre-marketing reports can include IND annual reports, clinical study reports (CSR), development safety update reports (DSUR) and annual safety reports (ASRs) in Europe.

PubHive is a cloud-based software company with a mission to make healthier literature pathways for life science companies across all stages of the commercialization lifecycle – from discovery to post-market. PubHive Navigator™, the company’s scientific literature workflow and analytics platform, streamlines repetitive work and lowers costs and compliance risk for teams in pharmacovigilance (PV), medical writing, and systematic literature reviews with additional solutions for medical affairs and R&D launching in 2022.

To learn more about the PubHive Navigator’s pharmacovigilance software module Pulse, please visit pubhive.com.

About PubHive

PubHive™ (pubhive.com) is a cloud-based software company with a mission to make healthier literature pathways for life science companies across all stages of the commercialization lifecycle – from discovery to post-market. PubHive Navigator™, the company’s scientific literature workflow and analytics platform, streamlines repetitive work and lowers costs and compliance risk for teams in pharmacovigilance, regulatory affairs, medical affairs and R&D. Powered by a proprietary Omni-Loop Artificial Intelligence (AI)™ engine, PubHive Navigator is the only 'fit for purpose' one-stop scientific literature platform today, distinguishing itself through flexible end-to-end workstreams and intuitive interfaces that make literature handling quick and easy.