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The Evolution of CROs—Convergence of Service and Technology Providers was presented by Mark A. Goldberg, MD, Chief Operating Officer, PAREXEL with Lynne Germscheid, Account Management, Clinical and Regulatory Operations, Merck Research Laboratories Information Technology. eClinical Technology Track, March 31, 2:15 p.m.
In the following Q&A, we asked Mark A. Goldberg, MD, Chief Operating Officer at Parexel to discuss the issues around his session topic.
Q: Can you discuss the top trends that support this evolution toward service and technology convergence?
A: The biopharmaceutical industry is facing many challenges ranging from price pressures and the patent cliff to increased regulatory hurdles. Fixed costs remain high while the R&D yield is too low. Meanwhile, the industry is undergoing a major transformation from a blockbuster to a niche buster development model that is focused on more targeted therapies. Ultimately, efficiency is essential, and simplification and innovation are going to drive that efficiency.
Technology, which is a cornerstone for realizing operational and financial improvements, can help drive process efficiencies, decreased cycle times, and accelerated decision-making through visibility to data. With truly integrated eClinical solutions, duplicate efforts can be eliminated, data quality can be enforced, and processes can be automated.
Due to the increased use of technology and growing complexity of clinical trials, the number of technology solutions being used in clinical trials is increasing. Emphasis is now being placed on the seamless interplay of the systems that comprise an eClinical Suite such as EDC, RTSM (Randomization and Trial Supply Management) technologies, CTMS (Clinical Trial Management Systems), ePRO (Electronic Patient-Reported Outcomes) and safety systems. As some of these technologies, such as EDC, begin to mature, even greater value can be derived from the convergence of technologies rather than from adding new features and functionality to a single application. The term convergence refers to the concept of making functionality that belongs to one application available through another. Convergence represents a level of connectedness, interoperability, and real-time data interchange that is greater than the term “integration” implies, where an additional technical solution is typically required to facilitate communication between systems. Additional value is introduced through ease of use, visibility to data, elimination of redundant data entry, and the reduced need for the reconciliation of various databases.
We also see an opportunity for sponsors to derive great value through the convergence between services and technology. With the maturation of eClinical technologies, sponsors are becoming less prescriptive about the specific technology solutions selected. The focus is on having the service provider deliver a total solution inclusive of whatever tools are necessary to execute a clinical trial. The ability for one provider to deliver the overall clinical trial solution, including the underlying technologies, brings new efficiencies, lower costs, higher quality, more flexibility, and decreased risk to clinical trial conduct.
Q: What is the impact on the partnership models and the benefits for sponsors?
A: Strategic partnering is accelerating the convergence of services and technology. By integrating technology into these relationships, companies can realize significant benefits. Partnerships create a novel opportunity for both parties to share a long-term perspective and to mutually benefit from reducing costs. Both partners are motivated to work together to create the leanest possible operational model. The long-term nature of partnerships justifies the necessary investments in the implementation of new processes and technologies. Achieving these benefits requires a new level of open-mindedness and a willingness to innovate. In many cases, this involves transformative change in the way that companies operate their clinical development organizations. Benefits of this change include lower costs due to operational efficiencies that come from standardization as well as volume based efficiencies. Additionally, quality and reproducibility are increased and timelines are reduced. Oversight and procurement costs decrease as one vendor assumes full accountability for the program. Furthermore, the fixed costs and depreciation associated with major technology investments of the past are replaced by variable costs. The utilization of a common technology platform supports enhanced communication and visibility, reduces the time and effort required for teams to collaborate, and enables operational issues to be surfaced earlier, leading to faster interventions or corrective actions where needed.
This type of collaboration between partners requires an explicit focus, including executive-level commitment and a close working relationship between the technology leaders at each company. Technology also becomes a focus of the overall governance construct of the partnership.
Q: What specific examples do you offer for the convergence between service and technology?
A: There are many examples of the advantages of leveraging technology innovation and the convergence of services and technologies. These advantages must be based on integrating systems between partners, developing convergent technology evolution paths, and building joint technology standards and libraries.
One example is the interoperability of RTSM technologies and EDC. With the ability for these systems to work synergistically, it becomes possible for an investigator to perform all patient-focused activities including data collection, randomization, and medication allocation within one system, with a single sign on, which significantly streamlines workflow. For the sponsor and service provider, data is immediately available and the need for reconciliation of databases is eliminated.
In another example, a partner was able to realize the advantages of a more predictable operational plan enabled by technology. Data capture, access to comprehensive data assets, and the use of predictive modeling were combined to allow for better country and site selection, and overall improved patient recruitment. The reduction in overall timelines compared to industry benchmarks was considerable, resulting in savings of both time and money in a critical development program.