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RESEARCHKIT AS A HEALTH DATA PLATFORM Bringing research to life Michelle Longmire MD Oct 11, 2017

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RESEARCHKIT AS A HEALTH DATA PLATFORM

Bringing research to life

Michelle Longmire MD

Oct 11, 2017

CURRENT STATE: CLINICAL DATA CAPTURE Episodic and static data

LIMITATIONS

• Sporadic and often random

• Not correlated with real world events

• Patient reporting has huge recall bias

• Relatively few data points

• Missing environmental determinants of

disease

FUTURE STATE: REALWORLD DATA CAPTURERich actively and passively collected data

BENEFITS

• Continuous data capture

• Anytime, anywhere

• Active and passive sensing

• Real world data

• Environmental context

RESEARCHKIT AS A HEALTH DATA PLATFORMShifting from the clinic to the cloud

Clinic Centric Patient Centric

Venue

People

Data Collection

Drug Supply

Sites

Doctors

EDC

Large Manufacturing Site

On-Person

Self

Mobile & wearable technology

At home drug printing

Patient Reported Sampling

and AdherenceEnvironmental Data

HEALTH DATA TYPESShifting from the clinic to the cloud

Connected Devices

Patient Generated Data Types

Data across diseases and populations

DIGITOMEDigital signatures of health and disease across populations

LEVERAGING DIGITOME FOR DIGITAL BIOMARKERSEnable a new era of insights with advanced analytics and machine learning

Patient Generated Data Types

Data across diseases and populations

DIGITOME TO DIGITAL BIOMARKERSLeveraging digital data to develop digital diagnostics

Configuring a Patient App with Clicks Step 1: Create a Study

Configuring a Patient App with Clicks Step 2: Add a Task to Your Study

Configuring a Patient App with Clicks Step 3: Add Steps to Your Tasks

Configuring a Patient App with Clicks Step 4: Add Logic

Configuring Smart DosingStep 5: Add Smart Dosing

Configuring Smart SamplingStep 6: Add Biomarker Samples

Configuring Smart SamplingStep 7: Add Connected Devices

Configuring Smart AnalyticsSteps 1-7 Automatically Defined and Create Unified Data with Time-Stamps

The Patient ApplicationExample Mobile Application

Eligibility

Consent

The Patient ApplicationExample Mobile Application

Survey

Signup/Login

Live DemoDemonstration of Medable Technology Solutions

PLATFORM POWEREasily Create a Scalable Smart Trial Solution

Development Deployment EnrollmentData

Analytics Compliance Security

Minimal

Clinic to Cloud

based Global

Deployment

Enable App

Based

Participant

Enrollment

Unified

Real-Time

Game Changing

Analytics

Across Studies

HIPAA

SOC1/SOC2

HITRUST

GCP

21 CFR Part 11

EMERGING DATA ON MOBILE APP BASED RESEACH PARTICIPATIONReduce trial time, trial cost, and improve data accuracy

Adherence Cost EnrollmentData

AccuracyTime

Compliance

and Security

3x

improvement

in adherence

with

notifications,

and

gamification

> 25% cost

reduction in

participation

costs alone

4x increase in

enrollment

On-going

efforts to

quantify

improvements

in data

accuracy

Decrease time

to completion

of trial and

time to data

Successful

deployment

across

geographic

regions

Thank you!