A new paradigm shift is now transforming outsourced clinical research and is giving rise to a new kind of contract research organization. The new paradigm is characterized by the digital CRO, which is enabled by widespread adoption of technology and constitutes no less than a change in the philosophy underpinning clinical research.
The new clinical research service model is based on a unified technology platform that enables integration, collaboration, and visibility 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.
Diagram 1: Digital CROs have flipped establish manual-based processes on their head. People are added to technology-amplified processes that aim to integrate systems, while reducing the coefficient of friction so trials run with less complexity and cost.
In the new service delivery model, 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 digital CRO is built around a method and approach that improves upon the traditional Contract Research Organization model by using technology-amplified processes to improve trial performance, visibility, and coordination among all stakeholders.
In contrast to the traditional CRO, which views technology as an add-on to a personnel-based model, the digital CRO 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 digital CRO, technology carries some of the work burden that would typically be carried by people, so the people component is smaller and less expensive.
With the traditional CRO service model opportunities for efficiency and cost savings are lost as information is imperfectly transferred from one functional silo (and technology platform) to another, and quality of the overall effort suffers.
Diagram 2: With the traditional CRO model, eClinical technology is an add-on that typically adds to trial complexity and cost, as there is an increase in “friction” points.
The digital CRO approach to resourcing clinical trials reduces costs by turning the traditional CRO approach to clinical trial resourcing on its head. Traditional CROs sell people by the hour and add technology to the people at additional cost. Traditional CROs also compartmentalize clinical trial functions, a practice that results in redundancy and wastes time (and, therefore, money) because of communications challenges.