While moving from paper-based clinical research processes to technology-based tools such as electronic data capture and clinical trial management have improved many aspects of the research process, layering these on top of existing (and often inefficient) methods makes cross talk and integration among functions difficult and expensive.
At Clinipace Worldwide, we have pioneered the digital clinical research organization (CRO), or digital CRO service delivery model, leveraging clinical trial technology as the foundation to all service delivery.
This approach delivers unified clinical trial technology that enables integration, collaboration, and transparency across all stakeholders. As a result of the digital CRO transformation, clinical trials have better quality control, run with enhanced efficiency, greater transparency, and at reduced cost.
Better Quality Control
The ultimate goal of conducting a clinical trial is to obtain clean, quality data upon which the competent authorities, healthcare providers, and patients can rely. The ability to attain this data depends upon expert and experienced people, good systems, and good processes. The digital CRO applies the right people to the proven processes and systems to ensure quality. The integrated nature of these trial processes and robust technology-amplified data validation enhance quality control and serve to minimize project risk.
The transparency of performance metrics that underlie digital CRO methods serves to instill sponsor confidence in clinical trial operations. In accessing the trial meta-data, stakeholders can see how standard operating procedures (SOPs) are/were operationalized in the trial. The integration of clinical and meta-data within a single system delivers a more comprehensive picture of the overall conduct of the trial. The use of clinical trial technology thus enhances quality control and project efficiency.
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 technology functions, a practice that results in redundancy and wastes time (and, therefore, money) because of communications challenges.
The adoption of digital CRO methods and the technology-amplified approach to clinical trials have brought about a shift to a new clinical research paradigm in which integration, collaboration, 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. The paradigm shift is transforming the process, quality, cost, and outcomes of clinical research for the better.
In a current Phase 2 trial in which a digital CRO is using technology-amplified systems and processes, the sponsor estimates a 30% savings in the cost of the trial – more than $1M in operational costs – simply from deploying resources more efficiently.