With sponsors facing increasing resource constraints, and CROs struggling to maintain TMF expertise in-house, the TMF has increasingly become a source of added study cost and delay – as well as potential delay or failure of the NDA.
Phlexglobal helps eliminate these resource risks and help ensure the ongoing health of your TMF project by easily expanding and enhancing your internal TMF capabilities with highly experienced TMF practitioners.
Our TMF practitioners have successfully mastered the challenges you and your teams face every day, averaging 10 years of hands-on experience conducting clinical trials, building TMF processes and SOPs, leading document management teams, implementing regulatory updates, and aligning eTMF technology to business processes.
With one of the largest teams of seasoned TMF professionals in the industry, backed by our tightly aligned in-house services, operations, and technology teams, Phlexglobal offers you TMF expertise that can scale rapidly to any project, anywhere in the world and at any time—regardless of your projects size, complexity, or duration.
Phlexglobal’s TMF Study Owner model provides you with unique flexibility to meet your particular requirements. We have provided everything from a single TMF professional for a two-week engagement at a small biotech and embedded TMF teams to some of the world’s largest pharmaceutical companies and CROs for multi-year engagements.
We have helped customers improve ongoing inspection-readiness and meet “impossible” deadlines. Phlexglobal frees up internal resources to do more with less and increases your TMF capabilities with a minimal effort.
Phlexglobal provides a unique Trial Master File solution by leveraging dedicated and authoritative TMF technologies and expert services to bring order, stability, and control to your Trial Master File – helping you achieve the highest standards for completeness, timeliness, and quality.
UK: +44 (0) 1494 720420
US: +1 (484) 324-7921
E-Mail: info@phlexglobal.com
