Clinical trial tech outfit Medidata ($MDSO) is expanding its work in risk-based monitoring, buying a startup called Patient Profiles to help sponsors and CROs use real-time safety data to make decisions on studies.
Patient Profiles, founded by two former FDA statistical reviewers, offers software that visualizes subject and site data, using proprietary algorithms to predict likely data errors and flagging anomalies before they can derail a study, the company said.
Now, after Medidata paid an undisclosed sum for the company, that technology will be folded into the Medidata Clinical Cloud, complementing the existing offerings in risk-based monitoring. The combination makes Medidata RBM the first cloud-based technology that integrates other operational data and patient data, the company said.
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| Medidata President Glen de Vries |
"Risk-based monitoring is such a key area for Medidata and the industry because of its ability to improve data quality and lower monitoring costs," Medidata President Glen de Vries said in a statement. "Integrating Patient Profiles into our platform is part of our focus on continual innovation and further enhances our easy-to-use, holistic RBM offering, which is helping sponsors and their CRO partners improve operational efficiencies and decision making throughout the clinical trial lifecycle."
Medidata has become an in-demand partner among the world's largest CROs, counting among its clients Covance ($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.
- read the statement