With insights from the Global TMF Center of Excellence, PRA assists top pharmaceutical and biotech sponsors in compliance and reducing risk by ensuring ongoing inspection-readiness with expert management of the quality, completeness, and timeliness of the Trial Master File. PhlexTMF technology supports this by providing effective sponsor oversight, streamlining collaboration and communication, and easily managing millions of documents across hundreds of studies.
“We are honored to work with PRA to provide high-quality TMF compliance to their customers,” said John McNeill, CEO of Phlexglobal. “As an industry leader consistently ranked among the top CROs and best employers worldwide, PRA recognized the critical importance of a high-quality Trial Master File for effective clinical development following GCP as well as successful submissions.”
PhlexTMF is the industry’s only eTMF solution that seamlessly incorporates both sponsor TMF requirements and the business practices of Contract Research Organizations (CROs) and Academic Research Organizations (AROs) to support their customers. With capabilities including the industry’s first AI-assisted indexing, embedded TMF Quality review, mobile scanning and classification, and the ability to easily manage multiple TMF structures, PhlexTMF helps organizations maximize their Trial Master File compliance and inspection-readiness.
Phlexglobal is the leading technology and services organization for clinical and regulatory matters with a focus on helping clients to master their digital agenda via proven AI solutions. Phlexglobal combines software and leading expert services to offer a unique solutions portfolio with easy to achieve automation via data generation that lifts organizations to a new level of effectiveness.
PhlexTMF is the company’s Trial Master File software. Regulatory solutions including PhlexSubmission for eCTD and CTD, PhlexIDMP, PhlexEVMPD, and PhlexRIM are considered highly innovative in the industry for out-of-the-box best practices capabilities, automation technology, and user-focused design. PhlexDistiller, a machine learning platform that reads documents and converts unstructured content into structured data, achieves automation of regulatory and clinical processes and completes the end-to-end solutions offering from Phlexglobal. To learn more about Phlexglobal, please visit www.phlexglobal.com.
About PRA Health Sciences
PRA Health Sciences is a full-service global contract research organization, providing a broad range of product development and data solution services to pharmaceutical and biotechnology companies around the world. PRA’s integrated services include data management, statistical analysis, clinical trial management, and regulatory and drug development consulting. PRA’s global operations span more than 90 countries across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East, and more than 17,500 employees. Since 2000, PRA has participated in more than 4,000 clinical trials. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 products. To learn more about PRA, please visit www.prahs.com.
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