Safety & Pharmacovigilance

Leveraging advanced data science allows Biorasi to do more for patient safety than just reporting on and classifying adverse events after the fact.
A proactive approach allows Biorasi to get ahead of safety problems, and maintain trial integrity and a lower risk profile.

Our clinical team achieves unconventional results

Bringing Pharmacovigilance In Line With Business and Research Objectives

Biorasi’s job is to identify the potential sources of risk and take a proactive approach to you and your patients’ safety needs, from study design issues such as inclusion/exclusion criteria optimization, through post-trial monitoring and follow-up. We don’t see Safety and Pharmacovigilance as existing in a vacuum; we believe that safety, research and business objectives can be in sync rather than in competition. The result: an integrated safety and pharmacovigilance approach that maximizes program success, minimizes cost and delays, and optimizes your entire development program.

Our Safety & Pharmacovigilance services include:

Safety database set-up and management

Safety case processing and reporting

Medical monitoring

DSMB charter development, selection, contracting, and management

Medical coding

Safety data review and management

Subject narrative writing

Optimization Turns Regulatory Challenges Into Opportunities

Better-optimized protocols lead to improved regulatory outcomes & approvals across more venues and markets, opportunities for new indications, and potential new paths to market.

Biorasi’s Safety and Pharmacovigilance group has one goal

Presenting our sponsors and relevant regulatory authorities with the best information and analysis regarding the health and safety of the subject patient population. How we reach that goal is what sets us apart. Our safety team employs a unique set of tools integrated into our TALOS™ platform, along with specialized training on those tools.

Our technology platforms enable our team to identify safety trends and potential health issues as soon as they manifest and give us the tools we need to respond quickly and efficiently to situations as they develop.

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An Unwavering Dedication to Patient Safety

TALOS™ integration allows for real-time monitoring of patient data, along with deep analysis to both react to, and predict, safety issues.

Office-based workforce allows our Safety team to work closely with Clinical, Project Management, and Data Science to deal with issues quickly and effectively.

Biorasi puts safety front and center, and this commitment is backed up by our industry-leading team, from FDA safety leaders to big pharma superstars.

Biorasi treats safety as more than just a regulatory requirement. Integrating with data science, Safety becomes a true driver that improves your entire program.

Patient safety is a consistent requirement across the therapeutic development cycle and must be constantly balanced against trial goals. Biorasi takes our commitment to safety seriously, with a best-in-class safety and pharmacovigilance team that knows how to ensure that powerful results don’t come at the expense of subject consideration.

Excellent results require planning

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