Technology and Data Harmonization for Enabling Remote Clinical Trials
Advancing Development of Medicine with a More Inclusive and Efficient Clinical Trials Process

The Process         Who Should Participate        Benefits        Participate        Contact        Resources        Events

 

The Process

This is a multi-stage, multi-year program with three critical functions:

  1. The development of a consensus-driven process workflow that includes the use of appropriate breakthrough technologies and ethical considerations for patient and clinical data governance, and regulatory compliance for clinical trials operation protocols from patient recruitment through to approval submission.
  2. An offline pilot that will test the developed workflow versus an existing traditional clinical trial study. The offline pilot results will provide a side-by-side comparative analysis of financial ROI, data integrity and auditing benchmarks, patient satisfaction, overall reduction of time and human resources.
  3. Submission of the proven workflow based on pilot findings for IEEE Conformity Assessment program to produce a certified workflow for complete remote patient trials for appropriate therapeutic areas.
Who Should Participate

We invite participants to share their expertise in this activity and welcome all individuals and representatives of organizations in the following areas:

 

  • New Technology Companies (AI, Blockchain/DLT, VR/AR, Sensors/IoTs, etc)
  • Existing Technology Systems (E-Informed Consent Providers, EDI, ERPs, etc) 
  • Sponsors of Clinical Trials (Bio/Pharma, Research Hospitals, etc)
  • Sites (Hospitals)
  • Investigators 
  • CROs (Contract Research Organizations) 
  • Regulatory agencies
  • Patient advocacy 
  • Academic researchers in clinical studies
Benefits of Participation
  • For sponsors and partners involved in conducting clinical trials
    • Test and evaluate the different cutting-edge technologies throughout the various areas of the clinical trials operations value chain. 
    • Collaborate with your peers by bringing your expertise and developing consensus-driven solutions in a neutral environment.
    • Walk away with a proven workflow and first-hand view of running and validating a remote trial without any financial or economic risk to your organization.
  • For technologists
    • Make your technology solutions and expertise available to the key stakeholders of clinical trials operations.
    • Establish trust in your technology and approach by enabling the program participants to test it and see how it works.
    • Bring your expertise in the technology to ensure the clinical and patient goals can be satisfied with the appropriate use of the technologies.
    • Drive adoption of the technologies by proving its application and helping to develop technical standards.
    • Be accredited as part of the development of the workflow.
  • For Partners and Stakeholders
    • Ensure your areas of interest are reflected in the development of the workflow (ie. regulatory, patients’ privacy, and more).
    • Bring your area of expertise to contribute to a workflow that will benefit those individuals and entities you represent. 
    • Become an advocate for the use of the workflow to create a more inclusive and efficient clinical trials process.
How to Participate

Participation in this program is based on an annual fee. The fees collected will subsidize the cost of operational and development support of this program. Participation fee are as follows:

  • Introductory 12 Month Offer: $499 (purchase before 1 December 2019)
  • Standard 12 Month Participation fee: $799 (sign up after 1 December 2019)

Please complete the registration form to secure your participation.

Contact Us

Program Chair
Tory Cenaj, Chief Editor and Founder, Blockchain Healthcare Today

IEEE SA Staff Lead
Maria Palombini, Director of Communities and Opportunities Development, IEEE SA
m.palombin@ieee.org

Resources
Upcoming Events
New York from above image

ConV2X Conference

Boston, MA
15 Oct 2019

WAMIII Event

IEEE SA WAMIII Workshop 

Rockville, MD
7-8 October 2019

HLTH Conference Featured Image

HLTH Conference

Las Vegas, NV
27- 30 October 2019

 

 

WAMIII Event

IEEE SA WAMIII Workshop 

Cleveland, OH
5-6 November 2019

Decentralized Pharma Featured Image

IEEE SA Decentralized Pharma - Clinical Trials

London, UK
February 2020
(website to be announced soon)