Unique Combination of Clinical Research Technology and Supporting Services

THREAD provides a technology platform to pharmaceutical, biotechnology, medical device, and consumer health companies that allows them to run more modern and digitally enabled clinical studies – also called “decentralized” studies – that limit burden on patients while maximizing access. THREAD’s platform includes a comprehensive and proprietary technology suite, powered by AWS, that allows patients and their families to participate in clinical research through mobile and web applications simplifying their experience to increase long-term retention. By moving the location of clinical research from a physical facility to a mobile or web application, THREAD makes research available to all eligible patients, wherever they are located.

The THREAD consulting services team consists of decentralized clinical trial, COA, and patient listening experts, trained to use a proven problem-solving approach to launch and manage your studies to support your clinical research goals. THREAD’s consulting service offerings have been refined over years of collaboration with sites, regulatory agencies, pharmaceutical/biotech sponsors and CROs, and support THREAD’s customers in the design and delivery of patient first clinical research programs.

THREAD’s Consulting Service offerings are segmented into two focus areas:

Implement Industry Leading Technology for Patient First Research

• Co-Create: Capture the actual voice of the patient to co-create protocols, obtain design feedback and reduce operational study risks.
• Define: Align on THREAD workflows, study specification and timeline
• Configure: Study app and portal prototype for review and approval
• Test: Internal quality control and customer user acceptance testing to validate the study application and portal prior to launch
• Translate: Translate dynamic patient facing content and generate screen reports
• Submit: Generate screen reports for IRB/EC and Mobile App Store submissions
• Train: Online certified courses and live study training for site staff, CRAs, data managers and other study administrators
• Launch: Publish mobile application on App Stores and/or deploy the study on provisioned devices Technology Support: 24/7 site and study team helpdesk and training resources
• Device Provisioning: Global logistics and management of phones, tablets and sensors
• eCOA Services: Licensing, translation and library configuration of validated COAs

Understanding the patient and the right endpoints through qualitative research, advanced psychometric analysis and biostatistics:

• Develop eCOA Instruments Implement COAs and digital health in clinical programs
• Design and Conduct COA endpoint analysis
• Clinically validate sensors and wearables
• Support Regulatory Submissions