E-clinical solutions provider Medidata took the DIA opportunity to unveil Balance, a randomization and trial supply management solution. Balance removes some of the complexities of subject randomization and then scripts an integrated voice-response system to execute the randomization plan.
The interlinked clinical trial functions of randomization and trial supply are becoming high-interest drug development topics. Although they did not rise to the level of SharePoint as a DIA topic last week, they've been gathering product--and service--announcement steam in recent months: Almac announced its IXRS 2.0 integrated phone-web patient and drug supply management system at the show. Nextrials and DATATRAK have brought the capabilities to the Apple iPad platform. BioClinica CEO Mark Weinstein promises to launch an integrated voice/web response solution in the second half of this year. And DHL has increased the number of its clinical trial logistics depots, extending its 3PL services to 64 countries.
All for good reason. "The last year has been desperate in some respects for drug development, with the industry coming out of a recession," says Graham Bunn, VP for partnerships at Medidata, in an interview at last week's DIA show. "There's a new level of cost consciousness. Users are looking for ways to extract more from e-clinical systems."
That includes eliminating the redundancies of multiple systems, a common Medidata theme. "There is no excuse for integrations that are less than seamless," says company president Glen de Vries.
Internet-based Balance integrates with the company's Rave EDC system, Medidata says in an announcement. It uses a browser interface for randomization design. A dynamic allocation algorithm creates subject assignments to treatment arms and strata, and a simulator tests the assignments and confirms compliance with study objectives. Supply and logistics information is accessible via Rave and the browser interface
- here's the announcement