The evolution and revolution of the CRA role
What is the future for a Clinical Research Associate (CRA)? Is the role dead? Is it still evolving? How do technological innovations impact site monitoring and the quality and costs of clinical trials?
The “Death of a CRA” story has been foretold, with some predicting that the role should already be gone (https://www.outsourcing-pharma.com/Article/2015/12/10/Experts-discuss-the-evolving-role-of-the-clinical-trial-monitor). The predicted “killers”? Risk-based monitoring (RBM) and targeted monitoring – all motivated by the obscenely high costs of on-site monitoring (https://medcitynews.com/2018/01/positioning-future-clinical-research-technology/?_hsenc=p2ANqtz-8grXqYKDW_cl9BXarjPUciaJ8VCnhPE1PRmRQqMkCrfVfri4kdfBUpnSqM5XdEVC-pSTe7fMIjxWsRcVpnohYcJN_ofg&_hsmi=59754077&rf=1)
The role CRA is still here and the demand for their skills to monitor sites persists. Why? Because there is still a demand for 100% Source Data Verification (SDV). Despite the predictions about RBM, most studies still require that all data is verified by human eyes. The major data problems must still be resolved by people working together. Problematically, having a CRA on site costs significant time and money. This standard must evolve into a better model. Is there a way to leverage the skills and knowledge of the CRA along with modern approaches?
CRA 2.0
I have experienced first-hand the progression of the CRA role, along with the current challenge for both CRAs and for the biotech, pharmaceutical, medical device, and the CROs who hire them, and I am leading a bold new approach to on-site monitoring. Not just an evolution, but a revolution. I believe CRAs are not dead, in fact, their role is more vital than ever for the future of clinical research, but in a different way that will add value to sponsors and safer, stronger clinical trials and better market reach for new therapies.
We all know this to be true, trials are getting more complex. The promise of technology is easing some of the burdens, but securing high-quality clinical trial information will still need human interaction and strong relationships based on trust and knowledge exchange. The patient data requires high-level scientific and content review. We should take advantage of technological improvements not to eliminate the CRA role, but to enhance it.
The CRA of the future?
The role of the Clinical Research Associate (CRA) has been changing, but I believe the role is not simply just evolving, but actually revolving back to its roots. The essence of the CRA, the reason the role exists in the first place, is to be a relationship-builder. The original and most important role of the CRA is to be the communication link between the pharma, biotech and medical device sponsors and the investigational sites.
With this a return to its roots, this “change” will lead to an increase in quality and a decrease in costs. In our new targeted model of source verification, our CRAs, who work closely
together with our CRA Liaisons (paramedical and medical experts who remotely monitor the data), go prepared and goal-oriented to the sites. They solve the complex data issues and patient safety concerns. CRA Liaisons work cross-functional to ensure the data is solid. This gives our CRAs the time needed to relationships with site staff that has so often neglected due to the high workload of 100% SDV.
There is a future for CRAs. The ‘Future CRA’ will actually need new stronger skills in relationship management, communication (http://www.clinitude.com/cras-and-communication-is-it-a-good-marriage/), and adopt a strategic working collaboration, approach and working with technological innovations. We agree with this statement about the role of CRAs: “The most important skills of a good CRA are safe from technology: the ability to establish and leverage relationships with investigational site staff; helping to problem-solve and assist investigational sites maintain compliance; being the face of the company to the investigators; and common sense.” (http://www.clinicaltrialsarena.com/news/operations/the-changing-paradigm-of-monitoring-and-the-evolving-role-of-the-cra-4997646)
I have been a CRA and have been part the evolution, now I am part of the revolution that is both decreasing site monitoring costs and elevating the trial quality and the importance of the CRA role.
Written by Sabrina Wijnen, CEO of Clinitude. Sabrina is a passionate believer in making clinical trials more efficient for both the sponsor and the CRAs. Contact her at sabrina@clinitude.com to ask about the revolutionary CRA Liaison program that saves trial time and money and makes sites, CRAs and pharma, biotech and medical device sponsors relaxed, relieved and, happy.