Jun 14 2010
Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today introduced Medidata Grants Manager 3.0, the newest version of its trial budgeting application in use today by many of the innovative clinical research sponsors in the life sciences industry. Now offered as a web-based solution, Grants Manager 3.0 enables users to build clinical trial grant budgets and benchmark them against Medidata's unique PICAS® database of negotiated trial costs without the need to install software. In addition to Grants Manager's sophisticated budgeting capabilities, version 3.0 also includes protocol complexity metrics and benchmarking to further refine the ability to predict trial costs.
“Working closely with sponsors, we have revealed how knowledge of the complexity metric can lead to lower costs for some trials by more accurately matching payment with actual work required of the site.”
The ability to benchmark planned trial costs against actual negotiated costs is crucial to enabling research sponsors to accurately manage grant budgets. The actual costs, however, only tell part of the story: certain study protocols require greater overall work effort of investigative sites than the norm, while other studies might require less. The complexity metric now incorporated into the PICAS database reflects the actual work effort required by sites conducting a procedure in clinical trials. This enables sponsors to further tailor grants to more closely reflect the work that will be required for their specific protocols.
"A growing number of pharmaceutical and biotechnology companies acknowledge that protocols have become far more complex during the past decade," said Ken Getz, senior research fellow at the Tufts Center for the Study of Drug Development (CSDD) who worked with Medidata to develop the Site Work Effort metric of protocol complexity. "The burden placed on investigative sites to execute protocol procedures has grown at a particularly rapid rate. As such, sponsors need to monitor investigative site work effort in order to improve clinical trial performance."
Grants Manager 3.0 also assists users in more quickly selecting the correct procedure for budgeting in a trial by showing the frequency of use of procedures by phase and indication. This latest version of Grants Manager also includes increased support for creating budgets in more than 80 countries and regions and improved methods for budgeting multi-arm studies.
"This new version of Grants Manager represents a significant enhancement in clinical trial budgeting by offering sponsors new ways of tailoring trial costs to site satisfaction," said Lori Shields, vice president of Medidata's Data Operations. "Working closely with sponsors, we have revealed how knowledge of the complexity metric can lead to lower costs for some trials by more accurately matching payment with actual work required of the site."
Medidata will be demonstrating Grants Manager in its booth #1517 at the Drug Information Association (DIA) Annual Meeting, held June 13-17, 2010 in Washington, D.C.
SOURCE Medidata Solutions
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