Medidata, a New York-based global provider of cloud-based solutions for clinical research in life sciences, and Pharmaceutical Product Development (PPD), a Wilmington, N.C.-based global CRO, are expanding their partnership to provide the life science industry with a more comprehensive approach to risk-based monitoring (RBM)—aimed at conducting drug development more intelligently, more quickly and more cost-effectively.

Glen de Vries, Medidata's president, said, "PPD and Medidata share a common vision of transforming drug development through the power of technology and the intelligent use of data for the benefit of our customers."

This effort combines processes to increase data sampling and tracking of source document verification (SDV) through Medidata TSDV (targeted source document verification) with site health assessments and risk evaluation through PPD's adaptive and intelligent monitoring. This new endeavor will afford clinical research associates increased scrutiny of targeted endpoints that pose the greatest areas of risk in studies. Through this new arrangement, the companies will track specific SDV requirements and compliance directly within electronic data capture systems and will have greater opportunity to focus remote monitoring on targeted critical data points.

In today's clinical trials, site monitoring costs can account for up to 30% of a trial's budget. By combining PPD's clinical trial experience in alternative monitoring approaches with Medidata's innovative clinical trial technology, the companies can jointly offer faster, less-costly data quality reviews, without compromising the core focus on patient safety and compliance with industry regulatory requirements.

"Medidata's TSDV solution closely complements PPD's adaptive and intelligent approach to risk-based monitoring," said Lori Eberhardt, PPD's vice president of remote site management and remote monitoring. "PPD adapts SDV sampling and clinical monitoring visit schedules based on site health recorded in Preclarus—our real-time data and analysis solution for consolidating and standardizing data from multiple sources.”

Eberhardt said, “PPD also offers clients its standard RBM solutions, such as adaptive and intelligent monitoring, that leverage the technological advances of Preclarus to adjust monitoring schedules on a site-by-site basis as a result of ongoing risk assessments. Combining Preclarus with Medidata TSDV offers an opportunity for us to increase the breadth of data used to develop these schedules and plans.”