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Paperweight Challenge

Regulatory agencies such as the Medicines and Healthcare Products Regulatory Agency (MHRA) expect, at a minimum, that a company’s trial master file (TMF) accurately reconstructs how a clinical trial was conducted to demonstrate effective sponsor oversight, support decisions made, and comply with Good Clinical Practice (GCP) guidelines. In addition, the MHRA has increased the minimum requirement to also have the TMF accessible and complete at all times.

Yet despite the technology options available on the market, many life sciences organisations struggle to meet this expectation. According to MHRA data, 35% of site inspections from 2014 were delayed because of incomplete or unavailable TMFs (1) and, in the latest report, two companies are cited as producing inadequate TMFs (2). This report also states that, in one case, “there was no single system that was designed to be the eTMF with the appropriate functionality”. While some of this could be down to a lack of purpose-built solutions, it is also a result of TMF operational process issues failing to keep pace with technology.

Go Paperless

As the industry migrates from manual, paper-based systems, many organisations struggle with this shift. The Veeva 2016 Paperless TMF Survey explored the life sciences industry’s progress towards paperfree clinical trials by gathering data from TMF owners around the globe (3). Since the first paperless survey in 2014, we have seen a major shift from passive to active TMFs, as sponsors’ adoption of advanced electronic TMF (eTMF) applications has increased nearly twofold to 24%. Sponsors using local file systems as their eTMFs dropped from 26% in 2014 to just 8% today. During the same period, clinical operations departments cut the use of paper for most, if not all, TMF documents from 41% to 28%.

Building on those findings, the Veeva Paperless TMF Survey 2016 observes that advances are being made in technology adoption; the clinical ecosystem is being simplified to allow for increased collaboration between stakeholders; and there is a marked reduction in the use of paper in clinical operations (4). Survey respondents employing eTMF applications continue to report great improvements in inspection readiness, as well as central and remote monitoring.

However, old habits die hard. TMF operating models often remain little more than electronic replicas of paper methods, despite technology automating some aspects of the clinical trial process. This means life sciences organisations must re-evaluate not only their technology platforms, but also their entire approach to TMF management.

By transitioning to more efficient, active TMF models, companies will be better positioned to thrive amid a challenging regulatory environment, a competitive global marketplace, and an increasingly complex partner network. The problem is that most businesses still use passive TMF models that archive data and documents at the end of a trial, rather than in real time as part of the natural workflow. An active model for TMF management ensures that all TMF documents, data and processes are managed in a system while they are executed.

Passive TMF
With a passive TMF operating model, documents are uploaded to the system only after they are sent, scanned and finalised. The out-of-date, inefficient paper processes still exist – only now, documents are saved in electronic format. Users conduct upfront work outside the system, and documents are then stored in multiple locations – the system does not track content throughout its progress, which means TMF activity is still segregated from broader clinical processes.

It is, therefore, difficult to observe study status in real time, capture vital data needed to evaluate TMF compliance and reconstruct how trials were run.

In addition, passive TMF management can lead to inefficient workflows, multiple versions of documents, delays and inaccurate metrics. Without reliable data, it is impossible to accurately influence business decisions or improve processes. Stakeholders cannot respond during the course of a study, make changes or redirect resources.

Active eTMF
Inspection readiness and compliance is a state of being, not a preparatory activity. Migrating to an active eTMF model is a far more effective way to run trials, as the TMF is maintained in a constant state of inspection readiness. Compliance is continuous, and operational metrics can be easily accessed.

All study partners can create, review and assess documents in a single system. There are no version control issues or inefficient document reconciliation – as the system has just one single source of truth – while automated workflows replace outdated, paper-based processes.

Active TMF management is a relatively recent concept, and the direct result of technological developments within TMF operations. Systems and procedures are indistinguishable in this model, because they work together to reach the end goal. Traditional content management systems and collaboration tools cannot support complex workflows or provide the access to data, documents and processes necessary to enable active TMF management. Applications designed specifically for TMF procedures offer access for all stakeholders and enable collection of valuable metrics to ensure TMF completeness and accuracy.

Luigi Visani is Chief Executive Officer of Exom Group – a CRO that combines strong medical, regulatory and operational expertise with the most disruptive digital technological solutions to improve quality and performance of clinical trials. Visani states that any delay in the start-up process inevitably impacts the time available to run the study itself, shortening the patient recruitment period. Exom Group uses an eTMF solution to optimise the start-up process.

“Firstly, the eTMF enables a quicker and more accurate collection of documents during the pre-study phase. These can be filed in real time and shared remotely with the relevant parties as required,” Visani explains. “Additionally, the presence of dashboard reports gives the study manager an ‘at-a-glance’ view of documentation completeness per site.”

The study start-up phase ends once the regulatory package has been approved, as the clinical monitor can then perform the study initiation visit. The eTMF significantly speeds up the review and approval of this package by giving the central reviewer easy and complete access to any trial document. Even requests for additional information can be handled more quickly.

“Using an eTMF means that we have full and secure control of all steps during the approval process across multiple recipients, saving considerable time overall,” Visani adds. “Even when delays occur due to local bureaucratic complications, the availability of an online document management system can help to more efficiently manage poorly responding clinical sites. Our experience shows that using an eTMF has significantly simplified and accelerated every part of the document management process.”

The implementation of an active eTMF system also provides more complete visibility over metrics, and further allows the eTMF to be used used in a more strategic way. Organisations can now view real time data on TMF completeness, timeliness and quality metrics, but they can also access operational metrics that may help inform business decisions.

Another example is Advanced Clinical, a CRO that has performed more than 250 clinical studies worldwide for sponsoring companies. For nearly a decade, the organisation relied on common, paperbased systems to collaborate with its customers on various documents, but these did not provide the real time visibility, access or in-process functionality that is so crucial to ensuring speed and compliance. In early 2013, the business moved towards an eTMF model. Now it manages all trial data and documents continuously in the eTMF for real time visibility across all stakeholders, including investigators and clinical research partners. The system automates many steps that were once manual, and captures an accurate audit trail for constant status on TMF completeness.

Achieving TMF Maturity

The movement towards paperless technologies and a more active approach to TMF management is gathering pace. According to the Veeva 2016 Paperless TMF Study (3), improving inspection readiness and accelerating study start-up are the two most cited business benefits driving eTMF adoption among sponsors (67% and 53%, respectively).

Remote oversight of the TMF (48%) and better visibility into performance metrics (40%) also rate high as motivators for eTMF implementation. eTMF application users report significant improvements in several areas, including inspection readiness (61%), better central and remote monitoring (59%) and increased visibility into performance metrics (55%). Users of other types of eTMFs, such as local or cloud file shares, are significantly less likely to see these advantages. When asked about the specific benefits in key inspection areas, nearly all respondents (98%) with eTMF applications saw major improvements in at least one area, including duplicate, missing or incomplete documents.

Life sciences companies say they want new technology and a shift in their approaches. Almost all of the 100 global life sciences organisations that took part in Veeva’s TMF Maturity Model Assessment programme reveal they want more active operating systems. The model marks TMF maturity on a scale of one to five, in which active TMF management starts at 3. Participants scored an average of 2.54, which suggests that most companies still have some way to go in adopting active TMFs – but the signs are promising. One medical device manufacturer, for example, scored 2.19 when it still relied on a paper-based TMF, but has since advanced to 3.2 on the scale after adopting a new active eTMF operating model and solution.

Integral Part

The eTMF is now an integral component of daily clinical operations. When documents are created, reviewed and acted upon in one system by all parties, it provides full visibility and enormous operational efficiencies. Organisations that implement the most advanced eTMF technologies are already expanding the scope of its use to not only help execute critical TMF activities, but also to plan and manage their overall clinical development strategies.

When a life sciences company uses eTMF technology for clinical trials, its TMF is no longer neglected until the end of a study but, instead, aligns technology with processes – not the other way around. It not only helps organisations plan, manage and execute their development strategies, but also maximises resources and, ultimately, enables innovative medical devices and drug therapies to reach patients faster. With an active approach, companies can get the most out of modern technology and be positioned to secure an insurmountable competitive advantage.

References

1. Visit: www.viglya.com/uk-mhra-updateddefinition- of-a-critical-gcp-inspection-finding
2. GCP Inspections Report, April 2016. Visit: www.gov.uk/government/uploads/system/ uploads/attachment_data/file/517483/ GCP_INSPECTIONS_METRICS_2014-2015__ final_11-04-16_.pdf
3. Veeva 2016 Paperless TMF Survey, June 2016. Visit: www.veeva.com/TMFSurvey2016
4. Veeva 2016 Paperless TMF Survey: Annual report. Visit: www.veeva.com/eu/ TMFSurvey2016


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Rik van Mol is Veeva Systems' Vice President, responsible for the Vault R&D suite of applications with a focus on the European market. He has nearly 20 years of experience in business/IT consulting and regulated content management in the life sciences/ pharma sector. Rik’s experience has been built on assisting clients through complex transformational programmes across the life sciences value chain, including clinical, regulatory and manufacturing/supply chain areas for some of the world’s largest companies.
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