Can a full-featured EDC be out-of-the-box?

Out of the Box, Full FeaturedEDC Clinical Trial:The Future is NowMarch 29, 2017Presented by Target Health Inc.Jules Mitchel, Joonhyuk Choi, Yong Joong Kim and Les Jordan

Broad Experience Base

Full Service CRO

Regulatory AffairsStrategic PlanningClinical Research

Data ManagementBiostatistics

Medical Writing

Technology Driven

Clinical Trials Software

eSource for Paperless Trials

Forms BuildereInformed Consent

ePROeIMPSAE

External Integration

Y E S !

Primary Question: Is a configurable out-of-the-box EDC possible?

FDA Approval

Target Health eSource• Audited by FDA • Successful de novo

510(k) approval • NDA submission

Trials for Drugs and Devices

At Companies Large and Small

Studies as Large as 40 Sites

And 900 patients

Target Health eSource

Flawless pre-approval site inspection

What are some of the qualities of out-of-the-box EDC?

FDA “Blessed”

Audited by FDA & used in successful NDAs

Paperless Trial eSource

One Website, One Login

End User Driven Forms Creation

End User Driven Edit Check Creation

How does an out-of-the-box EDC system work?

Build, Test, Run eInformedConsent Paperless Data Entry (eSource)

Manage Drug Supply

Central Labs (External Data) ePRO

SAEManagement

Monitoring

The ideal for EDC: one website, one login

eInformed Consent

Build, Test, Run

Paperless Data Entry (eSource)

Manage Drug Supply

Central Labs (External Data)

ePRO

SAE

Monitoring

Data Export

Build, Test & Run on the same system

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Build

• Define study parameters

• Easy to build forms & edit checks

• Map study data imports (Devices, Central Labs, Local Labs, etc.)

• Map study data exports

• Define reports• Version histories for

forms, edit checks, etc.

Test

• Ensure study works according to protocol

Run the Study

• Easy to use• Role based access

control and security• Site enabling• Sponsor enabling• CRO enabling

Data Export


eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Build







Test


Run the Study



Data Export

Build the form, with an easy to use interface

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Easy navigation

Simple iconography indicating configuration

Define edit checks without programming

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

End user focused, easy to define edit checks, still

programmable if necessary.


eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Build







Test


• Easy to deploy

Run the Study



Data Export

Deploy

Starting the clinical trial: Registering subjects

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring One system. No need to rely on external number generation.

Data Export

Determine: eInformed Consent or Paper

Flexibility in selecting eInformed Consent or

Paper Informed Consent

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Allow patient to sign Informed Consent

eInformed Consent as part of the EDC system means

one audit trail

eInformed Consent is part of the study website.

No integration needed.eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

eInformed Consent is stored as eSource

Investigational Sites control their own eSource

Out-of-the-Box EDC includes eSource document management

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

eSource EDC includes document management

Printable by site, if necessary

Original form, eSigned by patient,

eSigned by Investigator, stored in eSource management system,

all part of the EDC

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Data are entered by study staff

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Saved in eSource before saved to Study Database

Data Export

All data is stored first in eSource, then in study database

Audit trail of eSource

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

eSource record is viewable in PDF format

Everything is in eSource – all the source records are

in the same place

Even changes are stored in eSource first,

then into Study Database

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Randomization: Easy to navigate system reduces entry errors

No need to exit system for randomization

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Completed forms are easily identified

Randomization auto generated

Paperless (eSource) means fewer entry errors &

reduced monitoring costs

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Out-of-the-box EDC includes IMP management

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring Site requests the number of kits they need

Data Export


Site tracks kits received

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Out-of-the-box EDC includes IMP dispensing

Site dispenses kits to subject as specified by system & randomization scheme

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Out-of-the-box EDC includes IMP dispensing

Study staff dispenses assigned kit, tracked

in their inventory

Automation plus eSource means fewer errors & reduced

monitoring costs

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export


One website, one login means data is in real-time

One website, one login means exported data is up to date

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Out-of-the-box EDC enables data imports

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

LAB RESULTS: ABC Labs

Directly uploaded into EDC system by Central Lab

Data Export

Viewing Central Lab Data

One website, one login means everyone is viewing

the same data

External data can be viewed as soon as it is uploaded

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Providing for local lab data entry per site

Select Local Lab name

Units and Ranges are automatically

populated

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Out-of-the-box EDC includes ePRO

One Website, One Login for easily managed accounts

ePRO data is saved as eSource and

into Study Database

Data entered by the patient

Can be integrated with external ePRO systems

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Out-of-the-box EDC AE forms feed SAE module

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

User Interface elements are Role-based, providing

simple navigation

Data is entered once by study staff

Data Export

Investigator SAE reports are auto populated

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Data from AE form are auto-populated

into SAE form

Safety Monitor Report

Safety monitor can enter their narrative and other relevant

data

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

SAE Investigator Report

SAE Sponsor Report

Initial and follow-up reports in same

database, at same website

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Printable 3500A and/or CIOMS

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Onsite & Central Monitoring Reports - Overall

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Central Monitoring

Onsite Monitoring

Data Export

Central Monitoring Report – Interim Report

Auto-populated from EDC Database

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Online reports that enable Risk Based Monitoring

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Select the reports which indicate possible issues

Online reports that enable Risk Based Monitoring

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Identify the site(s) with issues

Identify the patients and visits requiring

follow-up

Out-of-the-box EDC enables data export

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Raw study data can be exported

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data ExportData Managers can

export raw data

Data can be exported

eInformed Consent

Build, Test, Run


Manage Drug Supply


ePRO

SAE

Monitoring

Data Export

Introducing 3rd Generation eSourceThe Next Generation of Target Health Software – Coming throughout 2017-18

EDC

Paperless Trials

Virtual Trials

“Enter Once” Clinical Trials Store Human Readable FormseTMF & Site Study Binder Some EMR Integration

21 CFR Part 11Web-Based Clinical Trial Software

Registry Based TrialsRemote Video VisitsVirtual Device VisitsSeamless EMR Integration

Recap: What are the qualities of out-of-the-box EDC?

FDA Approval

Audited by FDA & used in successful NDAs

Paperless Trial eSource

One Website, One Login

End User Driven Forms Creation

End User Driven Edit Check Creation

QuestionsContact Info:Jules Mitchel: [email protected] / Twitter: @JulesMitchelLes Jordan: [email protected] / Twitter: @ljrdn3Joonhyuk Choi: [email protected] Kim: [email protected]

mailto:[email protected]


