July 31, 2017
By Jim Reilly, BioSpace.com Contributor
It’s no longer a question of if, but when. The life sciences industry has begun its journey to unify applications with the aim of driving greater efficiency across the end-to-end clinical landscape.
The new Veeva 2017 Unified Clinical Operations Survey examined the life sciences industry’s progress toward a unified clinical environment. According to the survey of more than 300 clinical operations professionals from around the globe, 99 percent reported the need to unify their clinical applications, such as Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and electronic Trial Master File (eTMF) solutions. 
When asked what is driving that need, more than half cite faster study execution, improved study quality, cost savings, easier collaboration, and better visibility. On average, companies use four third-party applications to manage clinical operations (33 percent use at least five applications), so it’s no surprise they report challenges aligning information and processes across them all. This creates knowledge and reporting gaps that slow trials.
A unified clinical technology environment that brings together applications on a single cloud platform solves this problem.
Ora Clinical, an ophthalmology-focused clinical research organization, was looking for a way to connect all of its processes and systems when it discovered a cloud-based CTMS that’s part of a broader, unified suite of clinical applications. The company recently adopted the CTMS and now benefits from streamlined study management and greater visibility across its entire study portfolio. “The ability to bring together CTMS, eTMF, and study start-up on a single, modern cloud platform is a real game-changer,” said Edward Leftin, manager, Clinical Information Systems, at Ora.
Streamlining Clinical Systems and Processes
Many of the challenges companies face today in managing clinical trials stem from disparate processes and systems. Nearly all survey respondents report at least one major challenge with their clinical applications, and many report numerous challenges. Integrating multiple applications and trying to report across different applications are the two most often-cited problems – both caused by system silos. Furthermore, 50 percent of trial sponsors say that the inability to integrate their EDC or eTMF applications with the CTMS hinders their ability to improve clinical operations.
Survey respondents also say their current clinical systems are hard to use and don’t support collaboration. These issues likely contribute to the difficulties one-third say they face with data being tracked outside of their clinical systems. It makes end-to-end study visibility much harder. In fact, half of survey respondents cite better visibility as one of the most important drivers for unifying the clinical landscape, especially given the challenges most have with data reporting across multiple applications. The ability for companies to collect and leverage operational data throughout the clinical lifecycle has a direct impact on improving efficiency and execution in clinical operations today.
Overall, the industry’s transition toward a unified clinical environment is being driven by its need to address the silos created by legacy systems. Life sciences companies are taking steps to streamline their end-to-end processes and systems with modern cloud applications so they can execute faster and improve visibility across their study portfolios worldwide.
The Path to Unified Clinical Research
Many life sciences companies have started on a path to unified clinical research, enabled, in part, by the introduction of newer, more advanced applications and platforms. Trial master file (TMF) management has been one of the first areas to experience rapid transformation. Over the past four years, the survey shows a major shift as one in three (31 percent) sponsors now use an advanced eTMF application, more than double the number in 2014. As such, 79 percent of sponsors report improvements in inspection readiness. Modern eTMF applications also significantly improve activities key to unifying clinical operations and better managing the growing volume and complexity of clinical trials, including visibility into key study performance metrics.
There is also a significant shift underway in clinical trial management as life sciences companies expect to increase their CTMS investments by almost 15 percent each year through 2020. This is being driven by rising demand for data and site collection solutions and the availability of next-generation CTMS applications, Markets and Markets’ eClinical Solutions Market, Global Forecast to 2020. This is not surprising, given that nearly all survey respondents say challenges with their current CTMS applications are limiting their ability to improve clinical operations.
The next step forward will drive the unified model beyond clinical to allow information to flow through other parts of the organization, including regulatory, quality and manufacturing, commercial, and medical. As clinical trials are a critical part of the broader product lifecycle, making trial information accessible throughout a life sciences company will have a positive impact that ripples across many areas.
Going Beyond – Unifying the Broader Product Lifecycle
Clinical and other functional groups need to access much of the same information throughout the drug development lifecycle. Today, this is done using manual processes or complex integrations, but moving forward, different teams will access the same information in multiple ways. In the near future, there will be a single source of truth that can be consumed in context, by people who need it, regardless of their role in the organization.
For example, a lot of the same information needed in a regulatory submission is also needed in a TMF. Medical writing teams create protocols within a regulatory submission system. At some point, when the protocol document is approved, a copy is made, transferred to clinical, and placed into an eTMF. From that point forward, the information serves as the basis for much of the work that is done around the trial. Information collected throughout the course of the study will eventually need to be sent back to the regulatory submissions team so the submission can be sent to health authorities for approval.
In order to get this clinical trial information into a regulatory submission, regulatory operations will typically go through the process of copying many documents, including investigator CVs and FDA Form 1572s that are already part of the eTMF environment. With all this copying and transferring of content, there is no traceability between the different documents and opens up the opportunity for error. In the event a health authority makes an inquiry, the original source of information will need to be tracked down, but that source is several steps removed from the final submission process.
For these reasons, and many more, it’s vital for life sciences organizations to consider a more holistic model. Regeneron is an example of a company working to unify its applications across the enterprise. The global pharmaceutical company recently standardized on one cloud platform for both its submissions and eTMF applications to streamline content spanning two critical business functions—regulatory and clinical. Regeneron recognizes the need to manage common content on a single platform across its operations to speed product development, increase collaboration, and improve compliance.
“Collaboration is key to our success at Regeneron. Veeva Vault gives all of our employees and external partners a level of access and visibility important to improve collaboration in our trial processes,” noted Andrew Allen, director of clinical development and regulatory affairs systems at Regeneron.
Kelly Gage-Michaels, director of regulatory submission management at Regeneron, added, “It also enables us to do faster, more frequent submissions and, at the same time, improve collaboration and ensure real-time visibility between our regulatory and clinical teams.”
Today’s manual data collection and processing is grossly inefficient, cumbersome, and time-intensive. But, there is tremendous opportunity for companies to transform their operations through a unified clinical environment. Doing so will better enable the industry to 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. It’s essential to bringing together the entire life sciences environment and reducing the number of (often redundant) steps involved in drug development. Ultimately, streamlining how data is used not only within clinical, but also other areas of the organization will empower companies to bring innovative new therapies and drugs to market much faster.
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, please visit here.
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 jim.reilly@veeva.com
