SAFETY & PHARMACOVIGILANCE

 

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.

Balancing Risk in Challenging Pharmacovigilance Environments

Patient safety is a consistent requirement across the therapeutic development cycle, and must constantly be 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 powerful results don’t come at the expense of subject consideration.

Cutting edge tools

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

Safety Built in to Every Process

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

Experienced Safety Team

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.

More than just a “must have”

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

Bringing Pharmacovigilance In Line With Busines 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

"One of the rarest events, where we had to communicate [to Biorasi] to stop the screening rather than boost it."

VP of Global Clinical Development, Top Specialty Pharma

 

Latest News and Blogs

Eight Sponsor Essentials for a Successful Clinical Trial

It’s pretty common for a pharmaceutical company to have a list of demands ready when choosing a CRO partner for a clinical trial. Here at Biorasi, we have some demands of our own that we consider non-negotiable and vital to the success of any trial.

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