Digital Therapeutics use case

DIGITAL THERAPEUTICS USE CASE

For a start-up in DIGITAL THERAPEUTICS

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