The global biopharmaceutical services provider’s Global Data Operations (GDO) solution now includes a Clinical Metadata Repository (MDR) and an adaptive trials offering.
Jason Martin, corporate vice president of Global Data Operations, Parexel, told us two shifts in the industry are driving the need for the additional services.
“First, regulatory agencies are requesting greater standardization for submissions, as data sources continue to become more diverse,” he said.
Martin explained that the addition of the MDR “fills a gap” in data standards management by automating data collection and analysis processes from protocol development to final study report.
The MDR also provides interoperability between clinical data collected with different data standards and supports automated mapping, he said.
Additionally, Martin noted that a US Food and Drug Administration (FDA) guidance encourages the use of adaptive trials in the development of drugs, biologics, and medical devices.
“Regulatory agencies such as the FDA and the European Medicines Agency (EMA) share drug developers’ interest in the potential advantages of adaptive trials,” he said, explaining that Parexel’s enhanced adaptive trials offering under its GDO is a result of this shift.
The new Clinical MDR "will provide clients with improved quality and standardization of study build, mapping and analysis, while adaptive trial designs will allow clients to use data collected during the trial to make planned design adjustments that could improve trial efficiency and reduce risks for patients and sponsors," Martin said.
“Drug development is a long and expensive endeavor, and the industry is continually looking for methods to bring drugs to patients as quickly and cost-effectively as possible,” he added. “Parexel’s enhancements to its Global Data Operations are designed to support this effort.”