PubHive Adds Auto-Scheduling for Recurring Aggregate Safety Reports
PubHive Ltd., a cloud-based software company, today announced the launch of expanded aggregate safety report scheduling capabilities within the PubHive Navigator scientific workflow automation platform including auto-scheduling of future recurring reports, the ability to bulk-assign reporting project owners, and flexibility to support complex scheduling and distribution logic. PubHive Navigator’s new safety and vigilance platform capabilities supplement existing aggregate reporting and medical writing features, including scheduling, data collection, medical writing, report distribution and submission tracking, archiving, audit logging, and more.
“PubHive Navigator provides life science companies with a more efficient and compliant way to manage aggregate safety report scheduling and to perform medical writing compared to industry de facto standards,” said Raj Vaghela, President and CEO at PubHive Ltd. “Enterprise clients can use PubHive Navigator’s scheduling and writing capabilities seamlessly alongside existing safety systems. Clients that have not yet invested in such systems can also benefit by leveraging PubHive Navigator’s end-to-end aggregate reporting capabilities, which go beyond the a la carte needs that larger manufacturers may have.”
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 others.
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 drug safety and pharmacovigilance, medical affairs, regulatory affairs, research and development, information management, and other divisions.
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 automation platform, optimizes existing business processes and automates repetitive work for teams in drug safety and pharmacovigilance, medical affairs, regulatory affairs, research and development, 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 scientific literature and information handling quick and easy.