Solutions > Safety and Regulatory Data Analytics

Safety and Regulatory Data Analytics

Adverse event (AE) root-cause analysis can be complex, requiring access to large amounts of clinical and patient data. Regulatory reporting timelines add to the challenge given the complexity, scale, and telemetry of safety data. Trial and submission documents are time-consuming to author and review, while complying with differing international regulatory standards. bPrescient can help, with large-scale analytics to assess AE/SAE root causes and LLM approaches for navigating the global regulatory landscape.

Solution Overview Solution Benefits Relevant Expertise Example Tools and Data Sources

Solution Overview

Our solution for Safety and Regulatory Data Analytics includes:

Machine learning and analytics development to process trial and real-world data related to adverse events (AE).
Real-time analytics to enable timely reporting of AE/SAE events.
Development of large language models, trained on internal and public trial documents, that can author drafts of submission and regulatory documents.
Tools to provide automated review of documents in context of international regulations.

Solution Benefits

Partnering with bPrescient benefits your clinical pipeline in a variety of ways:

More accurate root-cause analysis for adverse events leading to improved trial outcomes and approval rates.
More efficient regulatory submission preparations and better input across available information, leading to cost savings.
Regulatory compliance with pharmacovigilance requirements.
Worldwide submissions that align with templates and guidelines and support faster review.