The MRCT Center and Medable created a task-force of diverse stakeholders with a core objective: tackling the nuanced ethical queries and regulatory discussions that arise with Decentralized Clinical Trials (DCTs).DCTs are studies executed either in whole or in part remotely, through telemedicine, mobile technologies, local sites, and mobile healthcare providers. This may greatly increase the efficiency and/or reach of a trial, but there are specific differences to consider between DCTs & traditional trials.

Medable & MRCT’s joint undertaking will be discussed in this comprehensive webinar, In the words of Dr. Barbara Bierer from MRCT Center, "The ultimate intention of this initiative is not just to provide a useful framework, but to truly equip IRBs, ethics committees, and sponsors with the essential organizational tools and guidelines that enable proportionate ethical review of DCTs."

These tools & guidelines are grouped into 3 domains: People, Remote Data Collection, and Data Oversight, with 12 total components that feed into a particular domain.

Watch this webinar where 4 industry spanning experts will cover how to equip your future digital/decentralized trial IRB & ethics submissions for success!

Key Learning Objectives

  • Dr. Bierer and Dr. Tenaerts will share best practice guidance encapsulated across all 12 distinctive components - including eConsent, recruitment & remote visits.
  • Jeff Nichols will highlight aspects of privacy and security unique to DCTs.
  • Carl Franzetti will detail issues related to devices (phones and tablets) utilized in DCTs

Who Should Attend

  • Clinical Operations/Development, TA Leads, R&D, Study Management, Project management, Regulatory leads, Compliance leads, Privacy leads, Chief Medical Officers, Chief Scientific Officers, Medical Affairs, Procurement, Clinical IT, Data management/processing/analysis,  and HEOR
  • Large Pharma and Mid-Market Biotech & CROs