PPD awarded for innovative eTMF development
The award was presented at OpenText’s annual Enterprise World conference and recognizes the company’s use of OpenText in developing electronic trial master files (eTMFs) for use in clinical trials.
“PPD utilizes OpenText to manage corporate-wide information governance programs, including related policies and procedures, records classification system, retention schedule, and development and deployment of records management-related training,” Jay Dixon, senior vice president of global quality and compliance for PPD, told Outsourcing-Pharma.com.
Additionally, the platform is used to manage all functional aspects of the eTMF process for Phase I-IV clinical trials and the delivery and tracking of end of study archival data.
“PPD also offers clients and inspectors access to SponsorView, a portal technology platform that enables users to view trial records in real time during the life of the trial,” Dixon added.
OpenText specifically recognized PPD for its development of a global, standardized process and taxonomy to manage the unstructured data acquired or developed during a clinical trial – which can often include more than 60,000 documents.
“The use of OpenText provides PPD with the necessary level of scalability for big data management,” said Dixon. “There is a level of flexibility within the platform that allows for either out-of-the-box reporting or customizable metric plans that we can tailor for specific PPD or client needs.”
As Outsourcing-Pharma.com previously reported, the industry has made great progress towards paperless trials. For example, clinical operations departments, which are the largest contributor to the TMF, have cut the number of TMF documents they manage on paper nearly in half over the last three years – from 43% of most to all documents on paper in 2014 to 25% today.
