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International Clinical Trials

MHRA Inspections: How Ready Are You?

A year and a half after the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) clarified regulatory expectations for accessibility, availability and completeness of trial master files (TMFs), new research shows that sponsors and CROs are adopting electronic TMFs (eTMFs) to improve their audit and inspection readiness.

In its second year, the Veeva 2015 Paperless TMF Survey shows measureable advances in the move away from paper and how those companies using more mature TMF technology see the greatest operational and business benefits. Cost savings (53%) and improved audit and inspection readiness (45%) are cited as key drivers for eTMF adoption again this year, consistent with last year’s findings.

Electronic Momentum

This latest survey shows a continued move towards removing paper: only 31% of respondents report their clinical operations departments are managing “most or all” TMF documents on paper – down from 43% last year. Email remains the dominant method (70%) of exchanging TMF documents between sponsors and CROs, followed by paper. The least efficient means of exchanging documents – paper and faxing – saw the greatest declines in their usage, compared with 2014. Only 13% of respondents report using faxing, down from 25%, and 47% report using paper, against 57% the previous year. At the other end of the spectrum, use of eTMF applications to exchange documents between sponsors and CROs is increasing and now used by 24% of respondents, compared with 15% last time.

Furthermore, most respondents see advantages in shifting additional activities to electronic, paperless processes. For instance, more than 63% say they believe managing TMF filing in an eTMF would shorten clinical development time, while 57% believe managing study/site start-up in an electronic application would shorten development time.

The industry-wide survey also reveals that eTMF adoption remains distributed across the maturity spectrum. In fact, 55% of those surveyed say their TMFs are little more than archives – file share, local file system, paper. Nearly one-third (28%) report using a content management system, and 18% an eTMF application, both of which can manage business processes. This evolution from simply electronic archiving to using an eTMF application as a strategic asset looks set to streamline clinical operations.

An eTMF application is built specifically to manage TMF documents and processes, and in the survey is reported to have the greatest impact on inspection readiness, compared with other means of managing the file content. Of the eTMF application users surveyed, 61% cite improved audit and inspection readiness as a particular benefit, alongside improved monitoring and better visibility.

Set for Inspection

Looking more specifically into inspection readiness, respondents using an eTMF application express significant improvement in eliminating misfiled (65%), duplicate (60%) and incomplete documents (55%). In addition, this year’s survey shows the desire for visibility into performance metrics as a key driver in eTMF adoption. Performance metrics provide adherence to study protocols and standard operating procedures, playing an important role in optimising clinical operations.

The life sciences industry is still in the early stages when it comes to realising the benefits of eTMF metrics to improve trial processes, and just 14% of respondents are extensively using performance data. Organisations that use metrics extensively find greater benefit from their eTMFs, compared to those that do not collect data – including better audit and inspection readiness (82% versus 25%) and improved remote monitoring (53% versus 0%).

Finally, remote access to the TMF for inspectors is becoming an important component to inspection readiness. One-quarter of all respondents grant remote TMF access to auditors and inspectors, amid projections that remote access will more than double to 65% within the next two years. A majority of those using eTMF applications (57%) are already granting remote access to auditors – more than twice that of other eTMF types.

Gradual Progression

This latest survey continues to demonstrate the shift away from paper and the increased level of benefits associated with newer eTMF applications now on the market. With TMF processes being an integral part of the clinical trial workflow, this gradual change in operations will ultimately mean improved efficiencies at every stage of the trial process, together with better preparation for audits and inspections.

The survey is available at:

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Rik van Mol is Vice President, R&D Strategy, Europe at Veeva Systems, where he is responsible for strategy for Vault R&D Solutions. He has 15 years of business/IT consulting and regulated content management experience in the global life sciences industry from companies such as IBM and PricewaterhouseCoopers. Rik has developed strategies and solutions in business areas across the life sciences value chain.
Rik van Mol
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