PPD teams up with Medidata on risk-based monitoring

PPD has expanded its relationship with eClinical outfit Medidata ($MDSO), combining technologies in risk-based monitoring to help sponsors use real-time safety data to make decisions on clinical trials.

Under the agreement, PPD brings Preclarus, an adaptive monitoring platform that allows researchers to monitor trial sites, while Medidata contributes its proprietary source document validation (SDV) technology. Together, the complementary technologies will allow study sponsors to quickly and cost-effectively keep tabs on multisite studies, the companies said. PPD will continue to market Preclarus as a standalone product.

Monitoring clinical trial sites can account for as much as 30% of a study's budget, according to PPD, and the CRO believes marrying expertise in setting monitoring schedules with Medidata's targeted verification system can improve bottom lines and timelines alike.

"Combining Preclarus with Medidata TSDV offers an opportunity for us to increase the breadth of data used to develop these schedules and plans," Lori Eberhardt, PPD vice president of remote site management and remote monitoring, said in a statement. "Partnering with Medidata to enhance our RBM strategy is another example of how PPD is taking advantage of our industry-leading people, technology and processes to offer more effective and efficient adaptive and intelligent monitoring plans."

Medidata has become an in-demand partner among the world's largest CROs, counting among its clients Covance ($CVD), Icon ($ICLR), INC Research ($INCR) and Quintiles ($Q). The company's know-how in adaptive clinical trials also lured TransCelerate BioPharma, a consortium of the world's largest drugmakers, which recruited Medidata in May to help it hammer out the case for adopting risk-based monitoring.

For its part, PPD has been steadily expanding its reach through partnerships and dealmaking, buying out the discovery-focused outfit X-Chem in September in an acquisition designed to bolster its early-stage capacity. Last year, the CRO bought out technology provider Acurian to better focus on clinical trial enrollment and retention services.

- read the statement

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