Pulse Module :: Aggregate Reporting, Writing & Tracking
Simplify aggregate safety reporting, writing & tracking
PubHive Navigator's Pulse module enables aggregate reporting teams to simplify periodic safety reporting activities, oversight, and inspection-readiness by moving from siloed Microsoft Office Applications to a centralized platform with end-to-end workflow and information management capabilities.
Here's just a few of the ways PubHive helps teams like yours
Schedule periodic reports in single a centralized calendar
PubHive Navigator centralizes reporting calendars in the same location where safety reporting activities are performed and related information is managed. With automatic calendar scheduling, tracking and notifications, aggregate reporting teams like yours gain peace of mind when it comes to fulfilling regulatory compliance and reporting obligations.
Simplify & automate ICSR source data collection for report inclusion
Say goodbye to emails, trackers and manually pulling data inputs from your safety database, safety management tracking software, and literature database search hits. With native signal management and literature management capabilities and robust integration options, PubHive Navigator puts the reporting information you need at your fingertips when and where you need it.
Streamline medical report prep, writing & approval processes
PubHive Navigator empowers you to make offline planning and Microsoft Office applications a thing of the past when it comes medical report preparation, writing and approvals. Our platform codifies manual processes into more efficient workstreams with intuitive online interfaces and automations that simplify medical report writing, approvals, and other collaborative processes.
Track reports across the lifecycle, from preparation to submission
Manual report tracking processes are prone to human error and increase the chances of missing important regulatory submission deadlines. This risk multiples as report volume increases into counts of dozens, hundreds, and even thousands each year. PubHive Navigator makes report tracking easy with a macro-level view of all reports and the ability to drill down into specific aggregate safety reporting projects.
Manage & archive documents in a single secure cloud location
From Periodic Adverse Drug Experience Reports (PADERs) and Periodic Safety Update Reports (PSURs) to Development Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs) and other regulatory reports, PubHive Navigator provides your team with a secure centralized location to manage and archive your report documents. This saves your team time when searching for information and eliminates silos by consolidating these into a single online location.
Access on-demand compliance reports & KPI analytics
You and your team need push-button access to generate compliance reports and KPI analytics. PubHive Navigator fills this void, saving you time manually compiling data in a ready-to-use format and understanding trends for project and the line-of-business.
Integrate data from literature, regulatory information tracking systems & other sources
PubHive understands that our platform is not the only safety system you rely on. Whether you have an existing regulatory information tracking system, literature database, or other software solution, PubHive can help you to simplify access to critical information inside PubHive by integrating third-party APIs into our platform.