Ready for a COVID-19 Medical Device Trial in the USA in 3 Clicks: A Case Study

The challenge:

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.

The approach:

  1. 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.
  2. 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.
  3. After site selection, she checked the opportunities for digital patient recruitment in the USA in terms of patients’ demand and advertising restrictions. 
  4. 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.
  5. 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 results:

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. 

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