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Simplify Site Negotiations for COVID-19 Investigator Initiated Studies

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The current industry approach for investigator initiated study negotiations between sites and sponsors can last more than two months. In the typical process, sites submit proposals to sponsors and wait for approval; following approval, sites submit protocols with high-level budgets attached. But two significant risks arise at this part of the process: the sponsor risks not setting the expectations for the correct level of budget detail needed, and, without benchmarking data, the sponsor risks not paying fair-market value. 

As the race continues to get treatments and vaccines for COVID-19 to market, companies cannot afford the timeline and regulatory risks associated with site negotiation delays. COVID-19 has spurred an influx of investigator initiated studies (IIS). For many sites, this may be a new disease area—site procedure costs will vary depending on location, and since IIS study budgets are developed by sites, sponsors and CROs need accurate information and reliable methods to negotiate.

A simple, empirical way to determine fair market value
PICAS is the clinical benchmark and cost database of negotiated investigator grants with a store of more than 320,000 grants and contracts and 29,500 protocols for over 1,800 indications. Medidata has developed a COVID-19 vaccination study budgeting solution, Rave Grants Manager for COVID IIS, which leverages PICAS to develop detailed trial budgets for patient, procedure, and site costs for IIS. This solution allows for IIS trial budgets to be turned around in a matter of hours, not days.

Rave Grants Manager accesses PICAS data to create budgets tailored to specific therapeutic areas, procedures, geographies, and indications, while identifying the financial impact of site selection and protocol changes. Rave Grants Manager for COVID-19 IIS establishes fair market value budgeting specifically for COVID-19 trials based on robust and defensible COVID-19–related data sets. Sponsors, CROs, and sites all benefit from quicker budgeting, quicker negotiations, and quicker approval of payments.

With Rave Grants Manager for COVID-19 investigator initiated studies:

  • Develop accurate and detailed site budgets for investigator initiated studies (IIS) - including patient, procedure, and site costs
  • Ensure fair, consistent, data-driven investigator payments around the world for COVID-19 vaccination and treatment indications 
  • Engage investigators directly to share study budget details, and then review and edit proposed budgets and contracts 
  • Mitigate compliance risks in IIS grants with defensible data through an audit trail of negotiation activity
  • Support financial reporting with transaction records readily available for analysis

Rave Grants Manager also includes a powerful tool called the complexity analyzer developed in collaboration with Tufts Center for the Study of Drug Development. The complexity analyzer calculates benchmarks with industry averages, along with a site’s work effort that procedures, visits and the entire protocol require. This helps sponsors and CROs determine site payments based on relative study complexity.

Learn more about how Medidata’s technology supports trials affected by COVID-19.

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Paul Oliver