It’s not easy to see the forest from the trees when standing in the middle of the woods, but thanks to new research on clinical trial operations, the areas for greatest improvement are clear. The studies confirm that many of the challenges sponsors and contract research organizations (CROs) face managing today’s increasingly complex clinical trials stem from the disparate nature of processes and systems. According to one CRO, Ora Clinical, the research spotlights how both sponsors and CROs can transform their operations by unifying technology systems across the entire clinical ecosystem.

The Veeva 2017 Unified Clinical Operations Survey, one of the industry’s largest surveys of clinical operations professionals, reveals a major transition is underway in the life sciences industry to streamline the clinical operating model. Nearly all respondents cited the need to better integrate their clinical applications, including EDC (electronic data capture), CTMS (clinical trial management systems) and eTMF (electronic trial master files). Faster study execution and improved study quality were the top drivers in bringing together end-to-end processes and systems.

“Integrating many disparate systems is very expensive and time-consuming,” said Ed Leftin, clinical information systems manager, Ora Clinical – a Boston-based global CRO that specializes in ophthalmology. “Every study is different, so things usually need to be tweaked for every subsequent technology integration, so this causes further delays.”

The survey showed that it is common for companies to use an average of five core applications to manage their clinical studies, with EDC and CTMS being the most commonly used applications. Beyond these, there are also various one-off tracking tools used for things like study/site status, and monitoring schedules. Nearly all respondents had at least one major challenge with their clinical applications. The top two challenges—integrating multiple applications and reporting across applications—are a direct result of system silos.

Two years ago, Ora Clinical hired Leftin to modernize their technology. He replaced aging, disconnected systems with unified, cloud-based technology, and has experienced a number of benefits. “Now, everything is easy to see in one place. This includes all of the regulatory and clinical documents, reports, a dashboard showing performance, and key metrics such as enrollment numbers. When you bring all of this technology together, you are providing sponsors with total transparency,” said Leftin.

Many systems lead to many challenges
Study start-up is a microcosm of the broader challenges companies face managing clinical trials, with multiple systems and tools involved the start-up process. Veeva’s research shows that the more tools a sponsor uses, the more challenges they report. A separate study from Tufts Center for the Study of Drug Development had similar findings, with 95% of sponsors reporting challenges with study start-up.

Also consistent with Veeva’s research, Tufts found that the time from the pre-study visit to contract execution accounts for the majority of the lengthy study start-up cycle time. Almost two-thirds of sponsors in Veeva’s survey say contracting and budgeting are one of their most challenging study start-up processes. Site identification selection and study planning during protocol design were the next most oft-cited challenges.

Purpose-built study start-up applications are relatively nascent, with only a small percentage of sponsors leveraging this technology. The vast majority still rely on spreadsheets to manage the complex study start-up process, reports Tufts Center, with roughly one-third or less using CTMS, eTMF, or homegrown applications. Companies that use two or more tools to manage study start-up practices report encountering at least three challenges. With so many tools and systems, it is no surprise sponsors are frequently reporting issues in the crucial study start-up process.

Modern systems are improving clinical processes
The introduction of newer, more advanced applications and platforms are helping sponsors and CROs start on the path to streamlining the clinical ecosystem. Trial master file (TMF) management solutions, for example, have experienced rapid transformation over the past four years, with one in three sponsor companies now using advanced eTMF applications, more than doubling since 2014. And, 77% of sponsors using modern eTMF applications report improvements in inspection readiness and managing the growing volume and complexity of clinical trials.

“We have significantly improved efficiencies across all of clinical,” said Leftin. “This is particularly evident with our eTMF, where everything is now done digitally in real time so there is little clean up at the end. The days of searching for paperwork to compile a paper TMF at study close-out are over.”

Similarly, there is also a shift underway with CTMS. A Markets and Markets report forecasts life sciences organizations will increase their CTMS investments by almost 15% each year through 2020 as sponsors report significant deficiencies in their current systems. Ora Clinical, as one example, recently implemented a cloud-based CTMS that’s part of a broader clinical suite applications. “The ability to bring together CTMS, eTMF, and study start-up on a single, modern cloud platform is a real game-changer,” said Leftin, “and will enable our organization to leverage the same business processes and workflows throughout the lifecycle of all our studies.”

The ripple effect
Clinical trials are a critical part of the broader product development lifecycle, including regulatory, quality and manufacturing, commercial, and medical. As the next big step forward, information will flow through to other parts of the organization and have a positive impact across many areas.

Clinical and other functional groups need to access much of the same information during different stages of drug development. Rather than using manual processes or complex integrations, cloud-based platforms enable different teams to access the same information in multiple ways without redundant effort. 

“After 25 years’ working in hospital systems where everything is electronic and connected, I was excited to be a part of bringing these changes to the pharmaceutical industry,” said Leftin. “At Ora, we have shifted away from paper in less than two years, and are working to unify our systems across clinical and regulatory. We have gained major efficiencies and streamlined workflows so everyone is rowing in the same direction with the greatest benefit of increased quality.”

There is great opportunity for both sponsors and CROs to transform their operations by streamlining their clinical environments. Doing so will help address the growing complexity of trials, support end-to-end trial processes, and drive new levels of efficiency and effectiveness across the entire clinical ecosystem. Further, streamlining processes and being able to leverage information throughout the development lifecycle has even greater potential expanded across organizations.

The Veeva 2017 Unified Clinical Operations Survey looked at the drivers, barriers, and benefits of a unified clinical operating model and tracked the move to streamline clinical systems and processes. For the full report, visit: http://go.veeva.com/2017-unified-clinical-operations-report. 

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Jim Reilly is vice president of Clinical Market Strategy at Veeva Systems, where he is responsible for defining the market approach for the Vault Clinical suite of products. For the last 15 years, Reilly has held a variety of senior positions in life sciences technology, where he has led software delivery and sales efforts in regulatory, clinical data standards, and content management. Reilly holds an MBA in Information Systems from Villanova University and a B.S. in Neuroscience from the University of Scranton. He can be reached at james.reilly@veeva.com