Global Academic Research Organization UCL Selects Phlexglobal's Innovative eTMF Solution to Enhance TMF Compliance and Inspection-Readiness Across Entire Study Portfolio

AMERSHAM, United Kingdom and MALVERN, Pa., July 28, 2021 /PRNewswire-PRWeb/ -- Phlexglobal announced today that UCL (University College London), one of the world's leading academic research organizations, has chosen PhlexTMF – Phlexglobal's advanced eTMF solution – to help UCL transform its paper-based processes and increase the efficiency, quality, and compliance of its Trial Master File management. PhlexTMF will support the entire portfolio at UCL's Institute of Clinical Trials and Methodology (ICTM), a pre-eminent center for clinical trials and amongst the largest of its kind in Europe. The decision by the UCL team followed a comprehensive tendering process with Phlexglobal appointed as the preferred bidder to help UCL streamline TMF management and oversight while reducing cost and risk.

"Having the support to make an organisational change to using an eTMF, to ensure compliance with the protocol, local SOPs, and relevant regulations was of primary importance in the selection process," noted Nancy Tappenden, Project Manager at UCL. "We also looked closely at whether the eTMF software could allow each of our four ICTM business units to retain control over its own portfolio of studies, while strengthening each unit's ability to collaborate with each other and with UCL's many development partners worldwide. We were quite impressed by Phlexglobal's ability to deliver on our requirements across the board."

Several other key factors stood out in UCL's selection process:

• Phlexglobal's extensive experience helping companies move from paper to an electronic Trial Master File, with the requisite understanding that effectively aligning people, process, and technology is critical to success
• Technology innovation that enhances quality, completeness, and timeliness across TMF management, such as the use of embedded Quality Review workflows, and a mobile scanning and classification app that will reduce the compliance burden for hundreds of investigative sites across UCL's global network
• The value of a predictable cost structure to help budget projections, and the ability of PhexTMF's SaaS architecture to improve global efficiency and compliance while scaling to UCL's future requirements

With UCL conducting extensive research into Covid-19 therapies in addition to its broad portfolio across multiple therapeutic areas, Phlexglobal also brought the organization into its industry-leading program for new customers involved with critical Covid-19 research. To date, Phlexglobal has actively supported dozens of companies across hundreds of Covid-19 studies – many of which have already received emergency use authorizations or are in Phase II and Phase III trials.

"We're honored that a highly respected research organization like UCL selected Phlexglobal for their eTMF solution," said John McNeill, Chief Executive Officer of Phlexglobal. "I applaud their targeted efforts to help develop Covid-19 therapies and many other critical health concerns. I would like to also congratulate our Phlexglobal employees, all of whom have made tremendous contributions and a truly extraordinary effort since the start of the pandemic. That is the heart of what will carry us through successfully to the other side of this crisis."

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About UCL
Founded in 1826 in the heart of London, UCL is London's leading multidisciplinary university, with more than 13,000 staff and 42,000 students from 150 different countries.

The Institute of Clinical Trials and Methodology at UCL is a centre of excellence for clinical trials, meta analysis and epidemiological studies. It has a focus on developing and delivering innovations in methodology that improve and enhance these studies.

The Institute is a pre-eminent centre for clinical trials and amongst the largest of its kind in Europe. It is part of the Faculty of Population Health Sciences in the School of Life and Medical Sciences, and is comprised of four clinical trials units:

• Cancer Research UK & UCL Cancer Trials Centre (virtual)
• Comprehensive Clinical Trials Unit at UCL
• Medical Research Council Clinical Trials Unit at UCL
• PRIMENT Clinical Trials Unit (virtual)

For more information please visit https://www.ucl.ac.uk/

About Phlexglobal
Phlexglobal is the leading technology and services organization for clinical and regulatory matters with a focus on helping clients to master their digital agenda via proven AI solutions. Phlexglobal combines software and leading expert services to offer a unique solutions portfolio with easy to achieve automation via data generation that lifts organizations to a new level of effectiveness.

PhlexTMF is the company's Trial Master File software. Regulatory solutions including PhlexSubmission for eCTD and CTD, PhlexIDMP, PhlexEVMPD, and PhlexRIM are considered highly innovative in the industry for out-of-the-box best practices capabilities, automation technology, and user-focused design. PhlexNeuron, a machine learning platform that reads documents and converts unstructured content into structured data, achieves automation of regulatory and clinical processes and completes the end-to-end solutions offering from Phlexglobal. To learn more about Phlexglobal, please visit http://www.phlexglobal.com.

Media Contact

Christopher D Englerth, Phlexglobal, +1 (215) 622-8798, [email protected]

SOURCE Phlexglobal