[This post is the second in a three-part series about the transformations that are occurring throughout the clinical research industry and Clinipace Worldwide’s effort to bring more efficiency and transparency to the process.]
The new clinical research paradigm is characterized by a unified technology that enables integration, collaboration, and transparency across all stakeholders: integration and collaboration among functions and roles across the spectrum of clinical trials components (e.g., Site Selection/Management, Patient Recruitment, Project Management, Monitoring, Data Management, Biostatistics) and project- and stakeholder-wide transparency of both clinical research processes and clinical trial metadata.
In the new clinical research 3.0 paradigm, integration and transparency foster an unprecedented level of information sharing, enable efficient information analysis for better decision-making, and provide the environment for conduct of a frictionless clinical trial.
While similar in many ways to a traditional Contract Research Organization, the dCRO is built around a vision of clinical research 3.0, which improves upon the traditional Contract Research Organization model by using technology-amplified processes to improve trial performance, visibility, and coordination among all stakeholders. Clinical research software integrates the spectrum of clinical trials functions in one platform accessible to all stakeholders; eliminating silos, which are often times, conceptualized and operate independently, each with its unique budget, systems, and software.
In contrast to the traditional CRO, which views technology as an add-on to a personnel-based system, the dCRO begins with technology as a platform and adds to it the minimum number of people to do an effective job. With judiciously employed technology, fewer people and resources are needed to do a job. In the dCRO, technology carries some of the work burden that would typically be carried by people, so the people component is smaller and less expensive.
Technology Is the Backbone of the Transformation, but People Are Its Heart
Although the current transformation occurring in clinical research (led by Clinipace Worldwide) is fueled by technology, technology is not its heart. Rather, people who share a vision of technology as a tool that can bring both unsurpassed efficiency to the process of running a clinical trial and unsurpassed quality to clinical trial outcomes are the heart of this research transformation. A shared passion for using technology for the success of the project underpins the culture of a dCRO.
To those people working in the digital Clinical Research Organization, technology is not an add-on to clinical trial processes; it is the backbone. The dCRO is guided by the philosophy that using technology to drive the clinical research process optimizes outcomes. The soundness of this tenet is intuitively obvious: in the process- and regulation-driven setting of a clinical trial, the use of technology should make the processes more organized, efficient, and transparent.
While clinical research cannot be completely automated, technology can bring visibility and control to a level not previously possible. In the dCRO model, technology facilitates the optimization of tailored resources so that just the right number of individuals—that is, the minimally effective number of individuals—becomes engaged in clinical trial management. In contrast, the traditional approach to clinical trials centers on providing (selling) people by the hour and each stakeholder adds his or her specialized technology. This approach increases costs, reduces collaboration, and makes processes more complicated.
The dCRO approach of using technology to optimize tailored clinical trial resources is changing the face of clinical research. Project stakeholders’ adoption of technology is transforming the way teams work individually and collectively toward common goals. As a result of these changes, clinical trials have better quality control and are run with greater efficiency and at reduced cost.
In part three, we’ll discuss the how the entire ecosystem will benefit from this transformation.