Phlexglobal has been a leader in Trial Master File strategies and solutions for decades. We know the ins and outs of not just creating feature-rich software, but making sure it runs effectively and efficiently on whatever IT infrastructure you’re working with.
Leverage seasoned Trial Master File Study Owners anytime, anywhere. Get practical training on TMF best practices and technology. Conduct efficient, accurate TMF migrations and imports at any scale.
Get a holistic view of completeness, timeliness, and quality. Pinpoint and correct TMF completeness gaps. Embed best practices around quality control and compliance. Access expert guidance for SOPs and eTMF technologies.
Align TMF technology with your people and processes. Leverage your eTMF to develop and automate better TMF workflows. Get hands-on, system-specific eTMF training. Identify what eTMF technologies can—and can’t—do well.
Ensure completeness, accuracy, and consistency at every step—including Paper Digitization, Index & QC, and Classify & Approve—regardless of your eTMF provider.
We draw on experience from dozens of Vault-related projects each year to address your specific situation and strategic goals.
Get a thorough quality assessment of your TMF, delivering detailed insight into quality and completeness.
Our TMF practitioners have successfully mastered the challenges you and your teams face every day—and are happy to share their expertise.
Expert TMF consultants with extensive real-world experience can help your company reach and stay in the TMF Health Zone.
Get a true picture of your acquired drug’s readiness for inspection or submission—and fix any problems that may stand in our way.
The term audit trail can be daunting for companies, but this is a regulatory requirement. Simply put, when it comes to the trial master file (TMF), if an action is not recorded in the audit trail,
We are thrilled to announce Season 2 of our exciting webinar program, Summer Shorts: TMF Excellence Edition! Avoid boring summer reruns and attend these fresh, informative sessions where our experts
Close-out of a clinical trial raises many questions about responsibility and management of the trial master file (TMF). According to ICH E6 (R2), final close-out can only occur when the monitor – or
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