Technology and Data Harmonization for Enabling Remote Clinical Trials

Advancing Development of Medicine with a More Inclusive and Efficient Clinical Trials Process

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ENSURING THE EFFICIENCY OF DECENTRALIZED CLINICAL TRIALS

The speed of research findings can be improved by considering decentralized clinical trials that combine elements of efficiency and implementation for research into routine adoption. The IEEE SA is the world’s largest technological association and can help healthcare researchers and clinicians advance technology for humanity by certifying new industry standards presenting a new frontier in clinical trials.

Join a multidisciplinary workgroup and collaborate to create IEEE SA certified standards for all stakeholders in industry to confidently apply in clinical trials for the digital era. The initiative will take elements such as protocol development, recruitment, delivering drugs, gathering data and audit trails and repurpose traditional methods for decentralized clinical trials. The group will design consensus-driven workflows that will be tested against a simulated trial to prove outcomes using newer technologies, devices, and wearables.

Program outcomes may identify:

  1. Enabling one original and immutable patient log from informed consent through publication of trial results
  2. Reduced cost and time to identify sites and train staff, patient recruitment and retention, quality control and data audit trails
  3. Restored data integrity and validation, requiring fewer resources for audit and submission for approval

Workstreams include but not limited to:
 

Protocol Development

  • Protocol Development and Institutional Review Board (IRB) Approval
  • Adoption of Standards for Decentralized Approaches for New Technologies
  • Fit for Purpose Devices to Enable Decentralized Study Design
  • Patient Privacy and Security
     

Recruitment

  • Digital Patient Recruitment, Awareness, Retention 
  • Training, Adoption and Support for Patients
  • Training Adoption and Support for Investigator Sites and Personnel
  • Patient Informed Consent


Shipping and Logistics of Clinical Trial Kits

  • Toolkits and Devices
  • Investigational medicine
  • Shipment provenance, tracking and auditing
     

Gathering and Validating Data

  • EHRs
  • Interoperability and data exchange
  • Real world data (RWD) as real world evidence (RWE)
  • Synthetic controls and digital twin simulation
BENEFITS OF PARTICIPATION


For bio/pharmaceutical enterprise 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 multidisciplinary stakeholders

  • Ensure your areas of interest are reflected in the development of the workflow (i.e. 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
     

Program Chairs and Advisors

(Co-Chair) Basker Gumadi, Director, Technology Innovation, Bristol-Myers Squibb

(Co-Chair) Walter De Brouwer, Founder, Doc.ai

(Industry Advisor) Craig Lipset, Founder and Advisor, Clinical Innovation Partners

JOIN NOW


Participation in this program is based on US$799 annual fee per person per 12 months. The fees collected will subsidize the cost of operational and development support of this program. Please complete the registration and payment form for individual participation.

Group Discounts Available
2-4 members from one company 10% discount
5 or more from one company 15% discount

When selecting this package you must register all members of your group at that time.

CONTACT

For more information on how to participate contact Maria Palombini IEEE SA Healthcare Life Sciences Practice Lead, m.palombini@ieee.org.

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