PhlexTMF for CROs

PhlexTMF for CROs is an electronic Trial Master File (eTMF) software solution developed by Phlexglobal, designed specifically to meet the operational and commercial needs of Contract Research Organizations (CROs) and Academic Research Organizations (AROs). Built on 20 years of TMF experience, the platform is intended to help CROs offer a compliant, inspection-ready eTMF capability to their sponsor partners while supporting multiple client standards, conventions, and TMF structures within a single system.

In the current CRO marketplace, eTMF capability is increasingly viewed as a competitive differentiator. A significant proportion of Requests for Proposals now ask CROs to provide eTMF services, and many sponsors prefer that their CRO manage eTMF content on their behalf. PhlexTMF is positioned as a SaaS solution built around the specific business practices of CROs and AROs, with pre-configured workflows designed to reduce time-to-value and streamline TMF operations.

Commercial Benefits for CROs

• Enables sponsor oversight in a cost-effective way, supporting a commercial arrangement with predictable costs for customers.
• Supports business development teams by providing access to Phlexglobal's market recognition, proposal content, presentations, and key differentiators to help drive new business.
• Provides a compliant eTMF offering that can be presented to current and prospective sponsor partners.
• Positions CROs to respond competitively to RFPs that require eTMF capability from potential partners.

Key Platform Capabilities

• Manages multiple TMF structures to accommodate the varying filing requirements of different clients, with the ability to apply study-specific logic to the default TMF structure.
• Provides highly configurable workflows with the ability to auto-assign activities and tasks to staff based on priority.
• Reports on eTMF completeness at any point in time, facilitating ongoing TMF Quality Review.
• Increases inspection readiness through management of timeliness, quality, and completeness of TMF content.
• Offers site access for electronic Investigator Site Files.
• Provides a cost-effective long-term archiving solution for CROs or their sponsors.

Implementation and Partnership Support

• Phlexglobal partners with CRO clients through every phase of implementation, sharing knowledge on how to support a broad range of industry expectations for both paper and electronic TMF content management.
• Provides accelerators such as templates to capture Client Conventions, helping teams get operational more quickly.
• Offers ongoing support to help CRO customers achieve continued compliance and inspection-readiness.
• Pre-configured, CRO- and ARO-specific workflows are included to streamline TMF operations from the outset.

PhlexTMF is delivered as a SaaS solution and is described as the only advanced eTMF platform built specifically around the business practices of CROs and AROs. Phlexglobal supports clients across the US, UK, Poland, and Germany, and positions the platform as a tool for enabling superior collaboration, communication, and workflow management across the full trial lifecycle from plan to archive.