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 Members Benefits Participate Contact Resources Events

Ensuring the Efficiency of Remote Clinical Trials

Clinical trials require extensive changes to the process to evolve into the digital era. The Industry Connections Technology and Data Harmonization for Enabling Remote Clinical Trials provides a forum to evaluate and test how to best utilize and harmonize the data outputs and capabilities of breakthrough technologies. These technologies include AI, Blockchain/DLT, IoT/sensors, and VR/AR in combination with current technology systems for conducting a remote clinical trials, from patient recruitment through to submission.

This program will seek to develop a consensus-driven workflow that will later be tested against an assimilated trial to prove the following outcomes:

a. A more efficient and inclusive patient recruitment and engagement process.

b. Restored data integrity and validation, requiring less resources (i.e. investments, time, etc) for audit and submission for approval.

c. Ability to enable one original and immutable patient log from informed consent through publication of trial results.

d. Reduced cost for identifying and establishing sites.

e. Reduction in cost and time for securing and establishing sites, patient recruitment and retention, quality control and audit of data.

The Process

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

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.
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.
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

Program Progress

More than 20 members representing Pharma, CROs, Technologists, Pharmacies, etc have joined the program including Walmart, BMS, UCB Pharma, PRA, and more
More than ten (10) working groups across two tracks have been established to develop a consensus-driven technical and business workflows for digitalization of clinical trials
A real-world telehealth clinical trial has been identified to test the workflows and ideas developed in the program

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: