Benefits of a Combined eCOA/eConsent Solution

Research sponsors and investigative sites are continuing to explore the use of eConsent in today’s clinical trials. Driven by the promise of improved support for participant comprehension and prevention of common consent regulatory deficiencies, switching to an electronic approach can reduce regulatory risk through the capturing of better quality data and a documented informed consent process.

What is somewhat less appealing for sponsors is the potential increased complexity that switching to a different approach might bring. Similarly, investigative sites are likely to be cautious of the integration of yet another technology platform into their study management, and all the training and process adaptions that would be inherent in doing this. Overcoming this perceived burden has driven CRF Health to develop an integrated electronic clinical outcome assessment (eCOA) and eConsent solution that can be delivered on a single device, enabling sponsors and study teams to gain all the benefits associated with eConsent, without adding layers to the development or additional technology systems.

We think that there is real reason to believe that integrating eCOA and eConsent could represent the most investigator and patient-friendly option when it comes to implementing an electronic consent solution, while better supporting the central IRB/IEC process for development and management of consents. As a single platform, study teams can enhance patient understanding, increase regulatory compliance and reduce quality risks, all while removing the additional burden for sites and patients that would go hand-in-hand with the use of a separate system.

The interchangeability can also better support the flow of documentation between all stakeholders. For example, the approved consent version can be sent to the trial master files of each stakeholder and the signed informed consent can then be made available in an electronic file format to upload to the site’s electronic health record. At the same time, an interchangeable approach would bring considerable cost savings by removing the need to purchase an additional system, as well as the time and costs associated with integration procedures and training. By implementing this kind of solution across multiple trials, there is also potential to drive significant operational efficiencies and create long-term cost savings due to companies no longer having to spend time rectifying issues arising from paper-based consent forms further down the line.

In a time when we are seeing an influx of technology across the clinical trials lifecycle, we need to move towards consolidating these technologies and bringing complementary platforms together wherever possible. For today’s investigators and sponsors, eCOA with eConsent may represent a welcome first step.

For further information on CRF Health’s solutions, please visit www.crfhealth.comMika Lindroos is Director of Product Management at CRF Health, and is most at home where technology meets humanity. With just over two decades in software product management in the global environment, Mika’s breadth of experience spans from product and portfolio management, strategy and business development, and heading a product line at Nokia, to revenue and business relationship development at Digia. Mika is a specialist in developing and managing relationships both internal and external to his organization, as evidenced by his varied roles in team motivation, change management, as well as customer relationship development.