PubHive Optimizes End-to-End Aggregate Safety Reporting Workflows
PubHive Ltd., a cloud-based software company, today announced the immediate availability of new end-to-end aggregate reporting and authoring workflow capabilities within PubHive Navigator, the company’s subscription-based workflow automation platform for scientific literature and information. Designed to eliminate siloed information and tools, PubHive Navigator’s safety and vigilance module now provides aggregate report tracking, scheduling with milestones, report preparation, writing, quality control, submission tracking, centralized document management, audit logs, reporting, analytics, and integration capabilities for safety databases and other regulatory information management systems.
“PubHive Navigator’s flagship safety and vigilance platform module Pulse has rapidly evolved. It now supplements best-in-class scientific literature surveillance and management capabilities with end-to-end aggregate reporting, writing, and tracking workflows,” said Raj Vaghela, President and CEO at PubHive Ltd. “Small, medium and large life science companies now have a more efficient way to perform their mission-critical work and to manage their information assets within a validated system that serves as a single source of truth.”
As part of aggregate reporting responsibilities, cumulative safety information from multiple sources is reviewed on a periodic basis with findings submitted to regulators. Reports focus on an overview, assessment of the safety profile and benefit-risk evaluation of adverse drug reactions (ADRs) and Serious Adverse Event (SAEs) for post-marketed and pre-marketed products. Supported report types include Periodic Safety Update Reports (PSUR), Periodic Benefit Risk Evaluation Reports (PBRER), Development Safety Update Reports (DSUR), Periodic Adverse Drug Experience Report (PADER), Suspected Unexpected Serious Adverse Reaction (SUSAR), and other report types.
PubHive Ltd. is a cloud-based software company with a mission to make healthier scientific literature and 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 automation platform, optimizes existing business processes and automates repetitive work for teams in safety and vigilance, medical affairs, research and development, information management, and other divisions. Powered by a proprietary Omni-Loop AI (artificial intelligence) Engine, PubHive Navigator distinguishing itself through flexible configurations, tailored workstreams, and intuitive online interfaces.
For more information about PubHive, please visit 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 automation platform, optimizes existing business processes and automates repetitive work for teams in safety and vigilance, medical affairs, research and development, information management, and other divisions. Powered by a proprietary Omni-Loop AI (artificial intelligence) engine, PubHive Navigator distinguishing itself through flexible configurations, tailored workstreams, and intuitive online interfaces.