Medidata and PPD partner to offer new approach to risk-based monitoring

The Joint effort to enable faster, safer and smarter clinical trial reviews for lifescience industry

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This new endeavor will afford clinical research associates increased scrutiny of targeted endpoints

Medidata and Pharmaceutical Product Development(PPD) has announced they are expanding their partnership to provide the lifescience industry with a more comprehensive approach to risk-based monitoring (RBM) aimed at conducting drug development more intelligently, more quickly and more cost-effectively.

"We are very excited about extending our partnership with a world-class CRO like PPD. We 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," said Mr Glen de Vries, Medidata's president.

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.

According to Ms Lori Eberhardt, PPD's vice president of remote site management and remote monitoring, "Medidata's TSDV solution closely complements PPD's adaptive and intelligent approach to risk-based monitoring. 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."

 

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