Biorasi assembles our project management teams from a diverse pool of high-performers with backgrounds in complex project management, medicine, regulatory affairs, science and business. Each sponsor’s PM team is hand-picked to fit the unique needs of the project, and we strive to maximize our knowledge base by keeping project staff on multiple studies within a single program whenever possible. Unlike the home-based staff many other clinical development partners employ, Biorasi project managers are office-based, as are most of the project personnel. Working in our offices as integrated study teams rather than home-based silos, we see better coordination and communication among and between our functional teams, which vastly improves the overall delivery of your project.
What Makes Biorasi’s Project Management a NEW Kind of Project Management?
Our approach to managing clinical trial projects isn’t the same as other CROs’. At Biorasi, we believe that only fundamentaly sound project management can ensure trial success, and that only properly trained project managers, backed up by industry-leading processess, and innovative tools, can ensure sound project management.
The Tools To Do The Job
Biorasi’s proprietary TALOS structure leverages best in class internal and external tools to make sure projects are completed right.
TALOS Optimizations, Guidances and References all provide Historical data and institutional learning to identify potential problems before they happen.
With the TALOS Control Center, Projects are optimized using historical and real-time study data to ensure milestones are hit on time, every time.
The TALOS WBS uses a scientific approach to Project Management – breaking down every task into simple actions to make sure nothing is missed.
Clinical Trial Success Isn’t Random – It’s Planned
Biorasi’s clinical trials project management team is powered by TALOS™. TALOS™ is an innovative platform and framework that allows our team to properly plan and execute strategies and tactics that are not only customized for every individual sponsor, but also draw on a shared and constantly improving set of processes, knowledge systems and standards. It is through this powerful project management approach that we consistently stay ahead of the inevitable study roadblocks, keeping your study on time and on budget, and ensuring the most optimal study outcome.
Our Project Management services include:
- Management of project deliverables, timelines and budgets
- Project metrics tracking and reporting
- Global project plan development
- Coordination and conduct of project team meetings, including investigator meetings
- Vendor mobilization and management
- Trial Master File set-up and maintenance
- Study transition (study rescue) handover and management
- Executive-level account oversight
"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
A common issue regarding “faltering” studies – studies that are not satisfying their time, cost, and quality parameters – is poor recruitment. Recruitment issues can delay deadlines and jeopardize the drug’s ultimate approval, if left unresolved. These delays are a...
Introduction Clinical trial rescues can often be a delicate topic for both sponsor and contract research organization. When a study goes off track, it’s natural to want to point fingers and look for who is to blame. However, performing a comprehensive root cause...