The #1 question we get from sites is this: will my sponsors or CROs "let" me use eSource instead of paper?
There's a clear answer: Choosing clinical trial software is not sponsors' or CRO's choice to make; it's yours.
The regulatory guidelines are very clear that source data collection is the responsibility of the Principal Investigator. This responsibility encompasses the methodology for collecting data. In fact, at many academic institutions and hospitals, research staff use their EHR as a source data collection tool. This is especially prevalent in oncology trials. So, the short answer is that sponsors are used to electronic source data collection and understand this is within the purview of the investigator.
What sponsors can do is validate the proposed software system to ensure it complies with FDA / GCP guidelines. This practice is within their purview of ensuring quality across the trial.
Sponsors' influence over your software system is similar to their influence over a PI's choice in sub-investigators. Clearly, you don't need the sponsor's permission to add Dr. Jones to your staff. However, the sponsor has the right to review Dr. Jones' credentials to ensure he/she has the appropriate training, experience and/or credentials to perform the delegated tasks on the sponsor's study.
Moreover, we often get this corollary question:
"Ok, I understand sponsors must let us use our system of choice as long it meets their compliance standards. But how do they really feel about it? Would they look favorably or unfavorably on us as a site if we use eSource?"
From our experience, validated by broader data, we have seen that sponsors and CRAs view sites that utilize eSource very favorably. After we saw evidence of this in our customers, we hired a third party market research firm to administer an anonymized survey of our CRA-users. By 3:1 margins, CRAs stated that the CRIO system is superior to paper on a number of dimensions, including data integrity, promotion of protocol compliance, and facilitation of rigorous quality assurance.
Curious about the data indicating that CRAs favored CRIO eSource by 3:1 margins? Download the free case study here.
We've also heard that many of our own sites utilize CRIO as a differentiator during site selection visits. For example, we know of one site that was chosen to be the lead site on enrollment because the sponsor felt that the site's embrace of eSource made the site well-suited to the trial, which was incorporating a novel technology. Another site told us they are a preferred provider to a foreign sponsor, in part because the CRIO system saves that sponsor the cost of having to perform on-site monitoring.
At the end of the day, what matters most to sponsors is site performance - the ability of sites to deliver the target number of patients and quality data. eSource has been shown to help you deliver both: more patients, because you free up time to devote to recruiting, and higher quality data, because there's a lower chance of error when data is recorded directly into a tablet.
All of this leads to the basic question that sites have to answer when deciding on a new system: Do you see eSource as promoting or hindering enrollment and PI oversight? That should ultimately be your prime criteria in choosing whether to take on a new system.
Are you a site who uses CRIO? Join the free co-marketing partnership and get your site listed on our preferred sponsor list!
Raymond Nomizu is a Harvard-trained lawyer and former clinical trial site owner; during the operation of his site, he realized that there should be a better software solution for clinical trials. This prompted him to co-found Clinical Research IO, whose eSource and CTMS solutions are now considered some of the best in the industry. Read more about him here.