SAFETY & PHARMACOVIGILANCE
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
Clinical trials in neurological diseases often mirror the complexity of the disease itself. Hence, a team tackling this type of clinical trial should make a number of assumptions, some of which are ubiquitous among other therapeutic areas while others are unique for...
Innovative and out of the box methods are often required for the recruitment of challenging populations in clinical trials that would otherwise fail miserably when using conventional recruitment strategies. In this arena, Biorasi has positioned itself as a pioneer and...