Virtual Trial Country & Site Selection Done in 1 Hour: A Case Study

The challenge:

Our client, a mid-sized US CRO was working on a phase II clinical trial in Atopic Dermatitis expanding to Europe. They had built in-house capabilities to support decentralized clinical trials and were keen to apply their methodology in a clinical trial targeting patients with Atopic Dermatitis. The challenge was that they did not have any previous experience in conducting such trials in Europe and needed help to:

  • Understand where they were allowed to deploy their technologies and services for remote patient support;
  • Identify the investigators who would be best equipped to work with a mix of face-to-face and remote visits and support options;

The approach:

Thanks to TrialHub‘s filters for virtual trial components used in clinical studies we were able to provide support in less than 3 clicks. 

  1. Once the CRO operational team had set up their Project on TrialHub, they turned on the virtual trial components filter.
  1. This immediately presented all the trials that have included some sort of remote support to patients as well as the Countries that approved this approach
  1. Next step was to export a list of investigators that have participated in such clinical trials and already have the experience providing remote support to patients in their countries.
  1. Last but not least was to submit more specific questions around e-Consent and telemedicine approvals to local advisors – experts in regulatory affairs and submission timelines, in order to receive a more detailed structure of what they should expect in each of the countries they identified as promising through TrialHub

The Results:

The CRO was able to get the regional big picture and in-depth understanding of the local landscape for conducting their decentralized clinical trial. At the same time, their sponsor was happy that the CRO demonstrated a real capacity to conduct remote support to patients in their clinical trial. 

Are you planning to incorporate virtual modalities in your trial? Check out The Ultimate Guide to Virtual Trial Vendors to find the best partners for your virtual/hybrid clinical trial among 130 providers and support your patients and operations remotely.

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