Most of us learned the hard way that you can’t do the same thing over and over again and expect different results. The same goes for any predefined vendor selection process. If you are looking for innovation and better results for your trial, the selection process itself should ensure that the vendor shares the same vision.
The next time you are deciding between one or more RTSM vendors, challenge yourself to think outside the box. The questions below will get you started. Then see what else you can come up with!
1. Can I try it before I buy it?
An RTSM is responsible for critical functions with direct patient impact. The decision to choose an RTSM should not be taken lightly, it is certainly not an impulse buy. It is not unreasonable, then, to ask the vendor if they can get a preview of how the system may work. In fact, ask your vendor if they can give you access to a sandbox environment. That way all the stakeholders that are involved in the RTSM decision, and study execution, can weigh in.
2. Can I approve the RTSM itself rather than the complex specification document?
Clinical trial professionals should not have to be technical experts. They should be spending their time operationalizing their study. So why are they responsible for signing off on lengthy, complex specification documents and crossing their fingers that nothing is lost in translation? Ask your RTSM vendor if you can approve the system itself, not the specification document. That way, there will be no surprises as you start UAT and no risk to meeting your FPI timelines.
3. How will you support my evolving protocol design?
As clinical trials become increasingly complex, relying on mid-study amendments has become the norm. This can pose a significant challenge for study teams in terms of financial and administrative burden, as well as introduces the potential for delays in the trial.
The good news is that modern RTSM systems can support a majority of changes through available system configuration options, often without study disruption. If a larger amendment is required, leveraging a flexible and robust architecture is essential to enabling the change without putting critical aspects of your study at risk.
4. Have you gathered direct site feedback on the UI and its ability to help, not hinder their daily workflow?
Clinical sites are the main end-users of the RTSM and yet chances are they are not given the opportunity to provide feedback on the usability of the system. Asking your vendor this question can help you decide on a vendor that truly cares about site satisfaction which can go a long way to improve the conduct of your trial.
5. Will this be a partnership?
Rather than just a "sponsor-vendor" relationship, your RTSM partner should serve as an extension of your trial team. There is meaningful value in a partnership where your vendor is invested in your outcomes, feels a responsibility toward the success of your study and advises (and occasionally challenges) your decisions.
In a partnership, you can trust your RTSM vendor to be the system expert - not only study support. This empowers your RTSM vendor to provide additional options for simplifying your trial design, supply strategies, provide guidance on how to adapt to change, and how to update the study for optimal outcomes post go-live.