With PhIII trial coming up, Infinity strikes risk-based monitoring deal with Medidata

Infinity Pharmaceuticals ($INFI) has added risk-based monitoring (RBM) to the suite of eClinical tools it sources from Medidata ($MDSO). The expansion of the 10-year relationship gives Infinity access to RBM technology at a time when it is gearing up for a Phase III cancer trial.

Cambridge, MA-based Infinity will use the technology in a clinical trial of its experimental treatment for indolent non-Hodgkin lymphoma. The expectation is that incorporating Medidata RBM into the trial will enable Infinity to allocate its resources more effectively, resulting in a reduction in the cost of the study and boost to the quality of the data it generates. Advocates of RBM, which now include the FDA and other regulators, think focusing on the data elements and processes that are critical to the achievement of study objectives can be superior to routine visits and 100% source data verification.

Infinity is among the biopharma companies to buy into the idea. "As strong proponents of risk-based monitoring, we share Medidata's vision and are pleased to be incorporating their comprehensive RBM solution into our clinical study," Infinity SVP Ross Pettit said in a statement. Medidata RBM enables clinical trial sponsors to dig through subject and site data to identify anomalies and key risk indicators. Armed with these insights, the sponsors can then enact a more targeted approach to the monitoring of sites.

The technology is part of Medidata's ongoing attempt to lessen its reliance on the Rave electronic data capture (EDC) system on which it has built its business. Medidata's evolving relationship with Infinity is indicative of how this branching out can work. Infinity began working with Medidata in 2005; since then it has used Rave and Coder across its research and development programs. Now, with Infinity's pipeline having advanced to the point at which it is working on multiple Phase III programs, RBM has become an attractive proposition.

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