Clinical programs come in different size, complexity and have variety of objectives. Typical mid-sized Clinical programs has nearly 200 + sites across 30 + countries and will have more than 20 vendors supporting the same (excluding sites).
With ICH specifically prescribing the needs for third-party oversight (addendum 5.2.2 and 4.2.6); you need to ensure and demonstrate on record that your clinical program have had adequate oversight from you.
BioDev acts as an independent partner for you, uncovering the performance of all your vendors and their sub-contractors in simple, decipherable & actionable dashboards. Our experts can work with your internal teams and your CROs – to ensure that your Trial objectives are met in optimized and compliant manner and your trial stays on the center-stage for all your vendors.
We can flexibly assume a light-touch, consultative role or can completely take responsibility of your Clinical program and ensure that you have complete visibility of your programs, on-time, every time, across the globe.
The worth of any R&D asset (NCE or NDDS) heavily depends on how optimized the R&D program for that asset is AND how effectively it is managed.
BioDev experts have significant experience in Program & Portfolio Management of R&D programs. We can work with your internal Research teams as well as Vendors and their sub-contractors to “thread” the program together, for a seamless, optimized & synchronous delivery of your programs.
We provide Program Management services for Pre-clinical (Discovery and Translational science) as well as Clinical development. Our experts would ensure that needs of your programs – either related with R&D Capacity or customized niche services are attended to by all vendors & their sub-contractors.
The specific Value that we bring on board are – Best price & quality from reputed vendors, Unmatched flexibility & Capacity planning; all of which ensure an optimized R&D program for you.
We can flexibly assume a light-touch, consultative role or can completely take responsibility of your Clinical program and ensure that you have complete visibility of your programs, on-time, every time, everywhere.