As the industry leader in Trial Master File best practices, Phlexglobal understands the reasons why some companies fail inspections and why others consistently do well.
While every organization is unique, these reasons inevitably come down to a single core principle: the alignment (or misalignment) of people, process, and technology surrounding the TMF. Customers place their trust in Phlexglobal because of our proven mastery over the TMF-related questions and challenges they face every day.
A thorough quality assessment of your TMF, giving you detailed insight into its quality and completeness.
Easily identify potential TMF problem areas and enable a risk-based remediation approach.
Our TMF Practitioners have successfully mastered the challenges you and your teams face every day.
Help ensure you are meeting GCP standards and regulatory requirements for essential documents.
Our expert TMF consultants help your company reach and stay in the TMF Health Zone.
Generate lasting benefits to your team and improve the overall health of your TMF.
Get a true picture of your acquired drug’s readiness for inspection or submission--and fix any problems.
Leverage Seasoned TMF Study Owners Anytime, Anywhere
Obtain Pragmatic Training on TMF Best Practices & Technology
Conduct Efficient, Accurate TMF Migrations & Imports at Any Scale
Get a Holistic Review of Completeness, Timeliness & Quality
Pinpoint & Correct TMF Completeness Gaps
Embed TMF Best Practices Around Quality Control & Compliance
Obtain Expert Guidance for SOPs & eTMF Technologies
Align eTMF Technology with Your People & Processes
Leverage Your eTMF to Develop & Automate Better TMF Workflows
Obtain Hands-On, System-Specific eTMF Training
Identify What eTMF Technologies Can—and Can’t—Do Well
Experienced people trained on effective processes using the right technology
Quality-driven Document Processing in any system helps ensure completeness, timeliness, and accuracy of documents
Customer-driven software designed by the TMF experts specifically for TMF requirements, aligned with the TMF Reference Model
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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
