By Ann Neuer

November 1, 2017 | The 2017 Veeva R&D Summit took an energetic look at expanding the clinical trial cloud and embracing collaboration as key to moving the life sciences sector forward. As presented in sessions on clinical, quality, and regulatory initiatives, the industry is trending toward simplifying the work of clinical trials through better processes and reducing the burdensome number of legacy systems in favor of end-to-end cloud-based solutions that unify content and data. The goal of these deployments is to make better strategic decisions across the clinical trial continuum, which will shorten timelines and improve operational data quality.

And pharma is demonstrating a willingness to change and an awareness that disparate systems can perpetuate inefficiency and inability to meet timelines. Senior Vice President of Veeva Vault, Jennifer Goldsmith, presented results of a recent, 300-person survey commissioned by Veeva and conducted by Fierce Markets. 49% of sponsors reported facing challenges integrating their eTMF or electronic data capture (EDC) application with the clinical trial management system (CTMS), limiting their organization’s ability to improve clinical operations. As a result, nearly all respondents, 99%, reported needing to unify their way of doing business by inching toward end-to-end processes and systems.

A TMF Initiation

Ed Leftin, manager of Clinical Information Systems at Ora, an ophthalmic CRO based in Massachusetts, has been on the fast track to implementing an end-to-end suite of cloud-based technologies, starting with the eTMF. On his first day at Ora in 2015, Leftin noticed someone pulling two carts down the hallway, both filled with paper documents.  Upon inquiring what was in the cart, Leftin was told that it was a trial master file (TMF). His response: “What’s a trial master file?”

Fast forward to 2017, and Leftin has more than mastered the ins and outs of the TMF. He and he team moved to risk-based monitoring, then to a set of applications providing fully integrated regulatory information management capabilities for electronic submission to FDA. And he didn’t stop there.

His team went on to implement electronic medical records, a study startup (SSU) application, and a CTMS. These technologies were a dramatic change from the paper-based methods that were standard fare, and as he explains, “I was hired to implement an eTMF as the foundation for an electronic clinical trial system.”

The need for role-based security, real-time reporting, and version control were the driving forces. And the company knew that it did not want any costly servers onsite that would eat up resources and require constant updating. According to Leftin, “We knew from Day One that we wanted a cloud-based hosted platform.”

A cloud-based eTMF was implemented first, in a speedy eight weeks. A Veeva product, it shares the Veeva Vault platform with the Vault CTMS, which Leftin’s team migrated from a paper system to the cloud in 90 days. As a result, execution and quality of global studies improved as measured by better adherence to timelines, fewer errors, and a shorter learning curve for new applications since they share a common platform.

Of particular importance is the ability to track milestones. For example, it is easy to spot holdups, such as why the clinical trial agreement is not yet completed. As for the eTMF, because everything is done in real time, Leftin explains, “There is very little clean up at the end, and no more time wasted configuring a paper TMF, so when the study closes out, it’s done.”

Having come from a sophisticated hospital IT environment, Leftin knew the critical importance of gaining buy-in from the C-suite as well as end-users if the implementation is to be successful. Key decision makers set the tone, but “You also need to find out how end-users work, what they do, and how they go about their day-to-day business.  We are looking to make their work process easier,” Leftin said.

In terms of measuring success, the various applications provide an audit trail, so it’s possible to know how long it takes for tasks to be completed.  Previously, there was no way to measure this, so it is difficult to pinpoint exactly how much time is being saved. Going forward, Ora is looking to add eSource and electronic informed consent.

Journey to the Cloud

At Eli Lilly and Company, the focus is also on streamlining clinical operations through a “fewer, simpler, and more strategic” approach, which refers to reducing the number of systems throughout the enterprise. This effort reflects a company-wide initiative to substantially speed R&D from protocol through submissions. To make this happen, the company noted in a recent Veeva press release that it intends to deploy a single, unified cloud platform and linked applications to more than 80,000 users.

Jeff Wagner, an Advisor in Clinical Development Information and Optimization at Lilly, said that until recently, Lilly had 30 to 40 disparate systems in clinical operations for functions such as SSU, eTMF, CTMS, EDC, imaging, safety, and more. The company relied on a multitude of spreadsheets prior to its journey to the cloud, and as Wagner stated, “We asked how we could simplify what we were doing and how we could change through use of new technology. We are working to reduce our footprint on some of these systems, and the redundancy.”

As this effort expands, Lilly is working to connect its internal systems, such as the eTMF and a single sign-on. Also, communications with investigative sites are being channeled through the common platform. “As we become more productive and the sites have more satisfaction, they will want to do more trials with us. Reducing frustration will go a long way toward delivering high quality information and building relationships. It’s about people, process, technology,” Wagner says.

For a company the size of Lilly, with some 40,000 employees across the globe, getting users, CROs, and other partners onto a unified clinical operations platform is no small task. “We are tackling a global audience of thousands, and we’re trying to get everyone on the same page,” says Wagner.