Notes…Refer to a section of digital tools for research…Some of the clinicians love to have new tools for conducting research even if these have not been FDA approved. A win win situation for start-ups who are doing exactly this:...looking for researchers with whom to conduct feasibility studies and proof of concept. Promote collaborations between the researchers and the early stage validation start-ups, perhaps Pharma included...to help discover new digital biomarkers that could be used as endpoints for clinical trials.

In this route the start-ups can use the FDA Biomarker Qualification program

https://www.fda.gov/drugs/drug-development-tool-qualification-programs/cder-biomarker-qualification-program

There are many companies that have made a business model out of the landscape:

We could make a schematic ecosystem where we would highlight how these collaborations work to promote this to happen...


Clinical Trials Transformation Initiative

Use of mobile technologies in clinical research

CTTI RECOMMENDATIONS: DEVELOPING NOVEL ENDPOINTS GENERATED BY MOBILE TECHNOLOGY FOR USE IN CLINICAL TRIALS

https://www.ctti-clinicaltrials.org/membership

Accenture

https://www.accenture.com/us-en/insight-digital-clinical-trial-future-clinical-development

All info in this article

https://digital.hbs.edu/innovation-disruption/software-enabled-clinical-trials/

https://airtable.com/shruk02yXe8TSPsAj/tblkNjsvmq9NvmIqO?blocks=hide

Elektra Labs

Regulatory

https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-workshop-content-premarket-submissions-management-cybersecurity-medical-devices-january-29-30

Add something about blockchain…

 Deloitte’s Report: Digital R&D. Transforming the future of clinical development.

https://www.accenture.com/us-en/insight-digital-clinical-trial-future-clinical-development

https://www.apnews.com/64035084cef44ae1946120131075c5fb

https://www.parexel.com/solutions/clinical-research

https://www.apple.com/researchkit/

Research:

MyHeart Counts App

Tata Consultancy: https://www.tcs.com/digital-clinical-trials

Summits:

https://clinicaltrials.conferenceseries.com/events-list/future-of-clinical-trials-and-technology-innovations

comment on the role of digital technology in the innovative design and conduct of clinical trials

https://www.clinicaltrialsummit.com/

Videos

https://videocast.nih.gov/Summary.asp?File=27414&bhcp=1

https://digital.hbs.edu/innovation-disruption/software-enabled-clinical-trials/

Patients like me

Harvard Business School digital initiative

https://digit.hbs.org/submission/patientslikeme-crowdsourcing-patient-platform-for-healthcare/

Bio-Optronics

https://bio-optronics.com/