DIGITAL THERAPEUTICS USE CASE

For a start-up in DIGITAL THERAPEUTICS

Digital therapeutics use case

R E Q U I R E M E N T

PROVE clinical performance of a Medical Device to reduce pain for Dysmenorrhea suffering patients from medical imagery data

S E R V I C E S  P R O V I D E D

  • DRAFT study synopsis, protocol, CRF, etc.
  • SET-UP & COORDINATE the clinical study (recruitment…)
  • AGGREGATE databases from both structured (e-CRF, Quality of Life surveys, biomarkers) and unstructured datasets (fMRI data)
  • BUILD a Machine Learning algorithm to correctly predict the areas of the brain linked to pain (linking e-CRF, QoL, biomarkers and fMRI data)
  • ANALYZE the effects of the Medical Device objectively by using statistical tests
  • WRITE statistical and clinical reports

D E L I V E R A B L E S  &  B E N E F I T S

STUDY DOCUMENTATION (protocol, CRF, etc.), various study reports, CLINICAL REPORT assessing the performance of the medical device and development of a new pain evaluation method

Requirement

PROVE clinical performance of a Medical Device to reduce pain for Dysmenorrhea suffering patients from medical imagery data

Services provided

  • DRAFT study synopsis, protocol, CRF, etc.
  • SET-UP & COORDINATE the clinical study (recruitment…)
  • AGGREGATE databases from both structured (e-CRF, Quality of Life surveys, biomarkers) and unstructured datasets (fMRI data)
  • BUILD a Machine Learning algorithm to correctly predict the areas of the brain linked to pain (linking e-CRF, QoL, biomarkers and fMRI data)
  • ANALYZE the effects of the Medical Device objectively by using statistical tests
  • WRITE statistical and clinical reports

Deliverables  & benefits

STUDY DOCUMENTATION (protocol, CRF, etc.), various study reports, CLINICAL REPORT assessing the performance of the medical device and development of a new pain evaluation method

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