Phlexglobal, a technology and services provider for the life sciences industry, announced the general availability of the industry’s first and only complete TMF management offering from a single expert provider. The company’s new PhlexTMF+ provides a one-stop, full-service solution that encompasses all the software and services required for effective TMF management and ongoing inspection-readiness. Organizations can be confident that their Trial Master File is being managed by experts every step of the way, from planning and document processing and study closeout.

With PhlexTMF+, life sciences organizations now have ready access to the latest advances in eTMF SaaS software, the world’s leading TMF experts, and best practices-based processes proven to optimize TMF quality, completeness, and timeliness – from a single provider and in one seamless offering. Companies gain ongoing TMF compliance, as well as the freedom to shift study resources from time-consuming TMF management to other critical objectives, reducing the risk of inspection findings and submission delays.

“You can think of PhlexTMF+ as ‘TMF management as a service,’” observes Karen Roy, Phlexglobal’s Chief Strategy Officer and Chair, TMF Reference Model. “By delivering everything critical to Trial Master File health, including purpose-built SaaS eTMF software, workflows, and expert guidance, we remove the burden of TMF compliance from our customers.”

Building on Phlexglobal’s decades of industry leadership in Trial Master File technology and best practices, the innovative new solution standardizes end-to-end TMF management to ensure consistent, accurate, and current compliance throughout the TMF lifecycle. What’s more, PhlexTMF+ fits each organization’s unique requirements, providing agile, fit-for-purpose TMF management – eliminating paying for software and services that don’t support TMF health.

Confidence that your Trial Master File is being managed by the industry’s foremost TMF experts, delivering the consistent quality, completeness, timeliness, and oversight necessary to achieve and maintain compliance

Rapid implementation of comprehensive TMF management with minimal customer effort, thanks to a standardized and proven methodology built on thousands of successful Trial Master File projects

Cost control and budget predictability through a fixed-price model that includes everything required for complete and effective TMF management, from industry-proven SaaS eTMF software to expert TMF services

Ongoing access to advanced technologies such as artificial intelligence and a time-saving mobile scanning and classification app, together with the latest TMF best practices such as quality control and completeness heatmaps

“PhlexTMF+ is further evidence of Phlexglobal’s authoritative position helping life sciences companies worldwide stay compliant with ever-shifting regulatory mandates,” said John McNeill, Chief Executive Officer of Phlexglobal. “We’ve transformed a traditionally siloed and challenging TMF management process into a seamless, expert solution from a single source, providing our customers with even greater compliance peace of mind.”