Virtual Clinical Trials: Between Regulatory Compliance and Creativity

In Part 5 of the Webinar “How Research Sites Can Win With Decentralized Trials” the panelists discuss questions about remote monitoring:

  • Why FDA’s ‘Go virtual’ green light is not enough on its own?
  • Why is harmonization between regulatory authorities so important?
  • Why digitalization on a country level is so important in Europe?
  • How do standards turn into guidance for conducting VCTs?
  • How to balance regulatory compliance with creativity?
  • How to document your SOPs to prove regulatory compliance?
  • What regulators can do to alleviate risk-averseness when it comes to VCTs?


Raymond Nomizu from Clinical Research IO, a site-centered electronic Source and CTMS solution;
Edye T. Edens, Senior Research Compliance Consultant at First Class Solutions
Daniel Perez, Chief Operating Officer at MACRO Trials – a Site Optimization Organization (SOO);
Maya Zlatanova, CEO of FindMeCure Ltd, TrialHub – Better Feasibility, More Business.  LinkedIn TwitterEmail

If you are planning to include decentralized modalities in your trial like eConsent, ePRO, remote monitoring and home visits check out The Ultimate Guide to Virtual Trial VendorsChoose between 130 providers of solutions for remote patient support and operations.

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