In a statement last August, departing FDA Commissioner Scott Gottlieb outlined several steps the agency had planned to further address the opioid crisis. Part of
WHAT MAKES BIORASI’S CLINICAL TEAM YOUR CHAMPIONS AT THE SITE?
TALOS™ allows Biorasi’s monitors to go into site monitoring visits armed with actionable intelligence about risks and areas of interest for each individual site.
ACTIVE SITE MANAGEMENT
Biorasi takes an active role in managing your clinical trial sites, from managing enrollment marketing to helping investigators overcome obstacles.
At Biorasi, we understand the importance of the clinical team in their role as the representative for you, for Biorasi and for the study, in the eyes of the investigators and site staff. Our clinical team understands there is more to study monitoring than just review of the source data; team members must act as trainers, planners, negotiators, detectives, psychologists and salespeople all at the same time. In doing so, the Biorasi clinical team achieves unconventional results from rapid site startup, through successful completion of enrollment and timely lock of the study database.
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.
Beyond Just Monitoring
Our study monitors are supported by talented and capable clinical team managers, physicians, assistants and specialists, and are equipped with state-of-the-art analytical tools to help them identify potential quality gaps before they become major quality problems. Our monitoring methodology synergizes the need to complete detailed project tasks with the benefit of viewing the project on a much higher, totality of the data, level. We leverage this methodology across all aspects of the study to bring greater transparency to our sponsors and improve the quality of the data compared to conventional methods.
Our Clinical services include:
- Site identification and selection
- Site contracting and budget negotiation
- Essential documents collection and processing
- Site initiation, interim monitoring, and study closure visits
- Risk-based monitoring
- Overall site management and communication
- Site training and audit support
Advances in stroke management, the first cannabinoid-derived drug approved, new therapeutics for progressive multiple sclerosis, early signs of successful treatment of diabetes and myocardial infarct