Authoritative Trial Master File assessment identifies and helps mitigate compliance risk of targeted or acquired products, minimizing inspection findings and submission delays
Amersham, UK; Malvern, PA. — March 7, 2021
Phlexglobal announced today that an increasing number of pharmaceutical companies, including five of the global Top 10, are utilizing Phlexglobal’s innovative TMF Quality Review solution to identify and mitigate potential regulatory risk for mergers & acquisitions and improve inspection readiness. Based on Phlexglobal’s global leadership in Trial Master File best practices, the unique offering provides in-depth analysis of individual studies as well as trend analysis across studies to help ensure the TMF meets GCP standards and regulatory requirements – with detailed, expert recommendations for necessary remediation.
Pharmaceutical organizations acquiring products or companies – as well as the companies preparing for acquisition – often discover too late in the process that the product’s Trial Master File will not be inspection ready. As a result, the TMF has increasingly become an important component of industry due diligence, helping to identify missing essential documents, major work remaining to be done, and potential compliance issues that could delay a submission.
“For regulatory agencies, the Trial Master File has become one of the most critical tools to measure the compliance and conduct of a clinical trial, allowing inspectors to easily identify problematic areas around essential documents and quality processes,” said Karen Roy, Phlexglobal’s Chief Strategy Officer and Co-Chair of the TMF Reference Model Steering Committee. “Phlexglobal’s expert TMF Quality Review solution helps companies identify what the inspectors will find, and provide pragmatic steps to achieve compliance.”
Phlexglobal’s expert TMF Quality Review solution helps companies identify what the inspectors will find, and provide pragmatic steps to achieve compliance.”
Karen Roy
Chief Strategy Officer
Phlexglobal
The unique Phlexglobal TMF Quality Review solution provides companies with the versatility to be applied seamlessly to any eTMF technology currently in place, in addition to Phlexglobal’s PhlexTMF eTMF system. Any organization can thus easily benefit from Phlexglobal’s unmatched Trial Master File expertise, together with innovative, purpose-built tools such as heatmaps with expert analysis which guides the quality review, risk-based assessments to quickly pinpoint and drill down to problem areas, and logic checks that validate not only the quality of individual documents, but whether those documents all relate to each other properly. The Phlexglobal team has performed hundreds of TMF Quality Reviews worldwide, offering companies the insight and data they need to improve TMF health and inspection-readiness.
“We’re pleased that so many of the world’s leading pharmaceutical companies are seeing the value provided by Phlexglobal’s TMF expertise, which is really a reflection of our deep pool of experienced and dedicated people,” said John McNeill, Chief Executive Officer of Phlexglobal. “We anticipate more and more companies in our industry to see the benefits of a proactive approach to regulatory compliance as demonstrated by our TMF Quality Review.”
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