There is a great deal of focus on technology solutions in the clinical trial space right now. While I remain cautiously optimistic that some of the emerging technology solutions will help sites operate more efficiently and reach more potential participants, it occurs to me that many, more simple solutions are being overlooked.

First of all, I want to heap a lot of love and appreciation on the role of CRAs in the clinical trial industry. They are so very often overworked, on the road way too much and their schedules just seem downright chaotic.

For better or worse, they are often the only real human interaction site staff have with whatever given study they happen to be working. Despite the fact that CRAs are often well-qualified, responsive and helpful, they simply can’t be expected to meet the needs of dozens of sites who are all competing for attention.

It’s not uncommon that CRAs are often thrust on to protocols that they simply don’t know well enough. Add in the fact that they have responsibilities to be performing monitoring visits on site, it can be impossible for other sites to get the information they need from their CRA in a timely manner.

I can’t begin to count the number of times we have had a patient on site, and we have an issue with a sponsor platform or simply have a question about how to navigate complicated parts of the protocol and are unable to reach our CRA.

This results in a bad experience for a patient who is forced to sit and wait and doesn’t exactly breed confidence in the team that is helping them. It also puts site personnel in a bind and discourages them from putting more effort towards this trial.

I propose sponsors can do a better job in providing support to sites by virtue of supplying a “protocol expert” or “study helpdesk” that is available to answer all study related questions in real-time. This wouldn’t need to be an elaborate undertaking but simply setting up a helpdesk or platform where an protocol expert of liaison could be reached could make all the difference in the world.

We’ve seen this type of role start to emerge a bit across a couple of sponsors/CROs but it is not nearly widespread enough. Who better than the sponsor who developed the protocol and workflow around it to answer these types of questions?

It feels like CRAs are put in an impossible position to try to understand multiple aspects of multiple protocols and serve dozens of sites. This simply results in a bad experience for everyone.

Sites really thrive on clarity and, unfortunately, they do not often get it through SIV slides and training videos that are more focused on mechanism of action of a study drug as opposed to how to practically carry out the study protocol.

Sometimes something simple can make significant changes.