Our client, a European CRO, was awarded a COVID-19 medical device clinical trial.
The specifics of this project:
- They had to conduct the trial in several US states as well, yet had no previous experience with such a protocol there;
- The medical device was related to COVID-19 testing;
Their main concern was the submission process and realistic timelines.
- Once she started working on this project, the Head of Operations created a Study on TrialHub targeting trial analytics about COVID-19 research and diagnostics in the USA. This allowed her to check other trials’ performance and expected recruitment challenges and have a more precise understanding of the recruitment rates with such trials.
- The next step was for her to identify the sites with the most experience in diagnostic testing, by also getting information about the ones with the least competition.
- After site selection, she checked the opportunities for digital patient recruitment in the USA in terms of patients’ demand and advertising restrictions.
- Last but not least, she requested a more detailed analysis of the startup timelines for such a protocol and thanks to a local expert, part of TrialHub’s Country Advisors Network, managed to get a detailed structure of the timelines and procedures for COVID-19 diagnostic research in some of the key states she was looking at.
- The cherry on top was that the local expert provided additional insights on seasonality and cultural and regional specifics around COVID-19 testing which might influence patient recruitment overall (for example where testing is being done, preferences of patients for being tested, etc.)
The operational team of the CRO got a full understanding of the landscape of COVID-19 diagnostic research and was ready to start their clinical trial on time. Most of all, thanks to the additional insights, they got a better idea of the patient recruitment strategy in different states.