Veeva Systems’ VP of R&D Strategy Rik van Mol told Outsourcing-Pharma.com that paper and email remain the main tools for exchanging documents between sponsors and contract research organisations (CRO), rather than more high-tech eTMFs (electronic trial master files) or a CMS (content management system).
He said the company had surveyed 252 companies working with trial master files and “they are at varying levels of maturity in their move to more paperless. Those using more sophisticated eTMF technologies report greater inspection readiness, visibility, SOP [standard operating procedure] compliance, and cost savings from their eTMF than those using basic file systems.”
Reluctance: cost, time, regulation
TMF owners have historically been slow to go electronic, a situation van Mol said is changing since the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) began to accept e-signatures.
“Additionally, the MHRA’s updated definition of critical inspection findings to include cases where ‘the TMF is not readily available and accessible’ is prompting a move to eTMF so regulators can access the TMF online. Cloud technology enables that accessibility and makes implementing and maintaining an inspection-ready eTMFs much easier.”
The company’s survey found 38% of respondents cited the cost of new technology as an impediment to installing eTMFs, 33% believed implementation time would be a problem, and 28% were put off by the prospect of regulatory requirements.
Challenges
Veeva maintained that advanced technology ultimately proves to be a money-saver. Of the surveyed companies which use eTMF applications, 47% reported saving money with the tool, compared with 29% using a local file system. Roughly half of the companies which had chosen eTMF tools said they had been driven by cost savings, speed, remote monitoring and audit readiness.
Companies transitioning to an eTMF system first need to rethink their approach to trial documents, van Mol said, so “they don’t just try to map their manual procedures to a new system that can enable far more.
“It’s crucial to rethink process and train people on how to best leverage the new system. Streamlining processes creates efficiencies, but if not managed appropriately can cause short-term pain. Taking the time to leverage best practices can help save time and effort.
“Companies also need to think about how to leverage metrics. Our research found those using metrics had far greater TMF quality. Yet, a surprising number of companies were not gathering or using metrics to improve trial processes. With an eTMF application, companies have real-time visibility into key performance indicators, but need to be sure to have a mechanism to translate those insights into real process improvements.”