What increases your chances of a trial coming in on time? Here are a few recommendations from our database of more than 260 sites.
1. User-friendly software
It is easy to see the software as a potential solution to your problems, but sites are unlikely to see it the same way. Three of the top five issues to keep your study on-track are software-related.
Have you ever gone through all of the software programs sites are required to operate to enroll patients and provide the necessary data? Have you reviewed the queries generated by your software to see if you would understand them?
To increase the chances of your trial coming in on time; have someone go through all of the software for enrolling, screening, randomizing, and data capture for each visit.
2. Avoiding ‘going underwater’
Sites, especially investigators, expect to avoid ‘going underwater’ financially when conducting studies. When sponsors require patients to be randomized before paying for additional screenings, sites with numerous screen failures will halt recruitment and enrollment.
Sites appreciate training that is specific to the study. They expect trainers to know the protocol, the software, and the hardware required to conduct the study. Collateral provided at the end of training should provide easy-to-access details about the protocol and what is to happen during each patient visit. We’ve received complaints of trainers simply reading 100+ slides and when finished reading, simply handing the massive deck to coordinators. That is not being helpful: That is checking a box.
For help getting your trials back-on-track, contact me.
Ross H. Weaver, PharmD, MBA