BALANCING RISK IN CHALLENGING PHARMACOVIGILANCE ENVIRONMENTS
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.
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.
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.
Navigating Complex Trials to Approvals
Biorasi’s methodology leverages our TALOS Ecosystem, an integrated technology and program management platform designed exclusively for Clinical Research. The efficiency of the TALOS Ecosystem offers greater success for our sponsors and allows faster trial completion while minimizing risk of failure.
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
Biorasi has a solid track record of experience in dermatology, and our goal for this year is to share all corners of our knowledge on