CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Barbara M. Bolten spoke with Dawn M. Furey, executive director, head of Global Operations, Global Clinical Trial Operations, Merck & Co. Furey leads the global alignment of strategies for implementation of clinical trial operations with a focus on trial feasibility and allocation, trial site documentation, enrollment/retention planning and support of project delivery. She also led the implementation of a cloud-based electronic trial master file solution, Veeva Vault eTMF.

Q: What are some of the challenges facing large pharmaceutical companies as they modernize their clinical trial architecture, in terms of both processes and technologies?

A: One of the biggest challenges facing the industry is end-to-end trial management and the seamless integration of information from multiple systems. Many large, established pharmaceutical companies that are managing legacy systems want to leverage the innovative technologies now available, but are challenged with how to integrate the new systems without losing historical information and documentation. We have to focus on how to get protocols designed, budgets created, visits designed, data from sites entered, sites paid and reports made available, all in one seamless flow. For example, we’d like to avoid the need to exit systems to search for information, perform redundant data entry, maintain spreadsheets and scan documents that have already been digitally created. All of those things are frustrations in the industry.

We use large data collection systems, and clinical sites feed information into those systems. As sponsors, we integrate and analyze the data, and different functional groups use it for different purposes. Technology has enabled us to more easily collect data; therefore, we are asking sites to provide us with more information, and we have a tendency to collect more information than we may need. This is partially driven by concern that if we don’t collect information, we may not be able to answer a potentially unanticipated scientific question later. Assessing which data is critical to collect is a challenge that I think the entire industry faces. Having a tool to help assess which information is most critical would be very helpful. If sponsors could see the dollarized value of the data collected, there might be a more critical assessment of whether they are collecting too much data that is just ‘nice to have.’

Q: Clinical operations teams may use as many as 20 different non-integrated systems to manage global trials. Despite all of these technologies, most study managers rely on manually compiled spreadsheets to view the status of trials across a study or portfolio of studies. What steps can companies take to unify their clinical trial systems?

A: A key first step to unifying clinical trial systems is to bring together like-minded individuals around some core common industry standards. It would be important to develop a scientific information management strategy that creates alignment and traceability across all clinical-related information management systems, such as the electronic trial master file (eTMF) and the clinical trial management systems (CTMS). Ultimately, the flow of information needs to become more flexible so that companies can create interoperability between platforms. At Merck, it’s increasingly important to create opportunities for cross-functional information sharing and collaboration to ensure that the various functions understand what the tools offer and what their role will be in creating an end-to-end solution for the business.

To that end, last year we moved to a cloud-based eTMF solution. We recently celebrated our one-year anniversary since implementation and continue to make improvements. For example, we would like to utilize a content management system to collect documents digitally and map them so that as soon as the documents go into the first digital system, they feed into our TMF. Those enhancements would remove the potential for human error.

Q: What advice would you offer to companies taking a similar path toward implementing new technologies for their clinical trial architecture?

A: We created a strong implementation plan for the transition of data, and made sure that we had the support and collaboration of a quality vendor. The amount of preparation for implementing our new TMF system made our integration hugely successful in terms of the transition of documents, and it lessened the pain for participants. I would suggest that others planning to bring on new technologies ensure that all functions understand the plan and the tool so that they are prepared to leverage its capabilities. Change-management strategies and communication campaigns to gather feedback from the different functional areas are often overlooked when creating an IT implementation plan. However, it is critical to evaluate how the various functional areas see themselves utilizing the technology, and which functionalities can be part of the initial effort or part of a second or third wave. Then everyone can feel that the technology is not just something that is being implemented by one group, but is really an end-to-end platform that supports the whole organization. 

This article was reprinted from Volume 21, Issue 07, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »