At a Glance PresentationJune 2017

The Human Digital CRO

Edition January 2018

Exom’s Mission

Modernization of clinical trials

• Transform clinical trials conduction by connecting new digital and mobile technologies, advanced methodologies and scientific expertise

• Engage patient actively and remotely to study participation

• Reduce clinical trial costs while increasing quality and performance

Genius SUITE®Cloud & Mobile Clinical Trials

The digital solution for clinical trials complexity

Genius SUITE®An integrated multi-modular cloud platform to enables real-time

and on-line management of any clinical trial activity

▪ Electronic Informed Consent (ENGAGE)

▪ Randomization to treatment (IWRS)

▪ Drug Supply Management (DSM)

▪ Patient’s Recruitment (eEnroll)

▪ Source Data (eSource)

▪ Project Management (CTMS)

▪ Trial Master File & Site File (eTMF/eISF)

▪ Mobile Data Collection (eCRF)

▪ Risk-Based Monitoring (RIBAM)

▪ Real-Time Study Metrics (INSIGHT)

▪ Patient’s Reported Outcome & Diary (ePRO)

▪ Patient’s Visits Calendar (AGENDA)

▪ Safety Report & Management (eSAE)

▪ Electronic Central Event Assessment (eCEC)

▪ Quality Management (eQUAM)

Our Technology Partners

Cloud & Mobile

Clinical Trials

All study activities through a

«Study Portal» and a tablet

Standard Study Portal functionalities

The solution: Genius RIBAM™

How to perform a Digital Quality Risk Management ?

New Requirements by ICH E6(R2) June 2017

Sponsor’s Risk Quality Management

……The sponsor

should implement a

system to manage

quality throughout

the design, conduct,

recording,

evaluation, reporting

and archiving of

clinical trials

The quality

management system

should use a

risk-based approach

Critical Process and

Data Identification

During protocol

development, the

sponsor should

identify those

processes and data

that are critical to

assure human

subject protection

and the reliability of

study results

Risk Identification

Risks to critical study

processes and data

should be identified.

Risks should be

considered at both the

system level (e.g.,

facilities, standard

operating procedures,

computerized systems,

personnel, vendors) and

clinical trial level (e.g.,

investigational product,

trial design, data

collection and

recording)

• RIBAM moves away from the

traditional approach of frequent

on-site visits and 100 percent

source data verification (SDV)

toward a combination of

activities, including centralized

data analytics and monitoring

• Ultimately RIBAM increases

Quality while reducing Costs

Genius RIBAM™ How it works

Genius RIBAM™ : central monitoring of

critical sites in details

Genius RIBAM™

Benefits

Genius RIBAM™ Metrics

To reduce time, resources and costs in study documents management and to be inspection ready

Genius eTMF™16

Genius eTMF & Inspection Readiness

• Inspections can occur at any time and we need to be ready to act

• The consequences of a failed inspection can be dire

• Inspection readiness is more than a “one time” event

Inspection Readiness : what does it mean ?

It’s means taking into account the

constantly evolving variables of clinical

research, to being able to provide all

required documents that prove that the

trial is GCP compliant

Effective clinical research

documentation,

Regulatory submissions,

TMF/ISF processes are

critical to inspection/audit

preparation

Inspection Readiness with Genius eTMF

1

Appropriate

filing and easy

retrieval of the

documents by a

search option

that means:

•Correct coding

(= name) of

the documents

•Correct

classification of

the documents

2

Documents

filing on an

ongoing basis

3

Quality Controls

on an ongoing

basis

4

Remote access

to study

documents from

any place and at

any time

5

Effective

security features

to avoid

unnecessary

deletion or

change of

documents from

the site

6

Real time

metrics on filed

documents

Genius eTMF : advantages and benefits

1

Availability of

documents

globally,

addressing

issues with

access for all

concerned

parties

2

Reduces

duplication, so

only one version

needs to exist

3

Reduces

fragmentation

of the TMF

4

Ability to

provide access

to the same

type of

document

across all

studies/sponsor

s/product

5

Search features

6

Environmental

benefits (reduces

need for paper,

document transit

and travel for

audit/inspection/

trial

management

etc.)

Genius ENGAGE®the electronic Informed Consent

CRF Health - State of eConsent 2017 Report

Limitations of the paper Informed Consent

The results of a study conducted in 2013 by the Center for Information and Study on Clinical Research Participation (CISCRP), showed that patients who were not satisfied with or did not understand the informed consent process were much more likely to drop out of a trial than those that were satisfied with the process

The solution: moving from

paper Consent to eConsent

The eConsent

▪ Electronic informed consent (eConsent) provides the

same information, but in an electronic format that

may include multimedia components

▪ It is important to note that eConsent is not meant to

replace the important discussion between the

participant and site staff

▪ As with traditional consenting, the site will continue

to own the consenting process

Why moving to the

electronic IC ?

What is the process for eConsent at sites?

Genius ENGAGE™is an unique solution for the electronic Informed Consent (eIC) since it is integratedwith the eTMF and the eCRF

Genius ENGAGE™includes a patient’s quiz for testing his comprehension of the content of the IC

Genius ENGAGE supports both the manual signature of the paper ICF as well as the electronic signature

The electronic signature process is protected by a PIN code delivered automatically by the system to the patient’s mobile phone

The patient will sign the ICF by typing his name or writing it with the finger on the tablet

Genius ENGAGE™ provides an audit trails of the informed consent workflow

Paper IC vs the Electronic IC

CRF Health - State of eConsent 2017 Report

Performance and Metrics of the eConsent

The eSource Data

Revolution

eSource Data Attributes (ALCOA)

The following attributes are considered of universal importance to source data and the records that hold those data :

• Accurate

• Legible

• Contemporaneous

• Original

• Attributable

• Complete

• Consistent

• Enduring

• Available when needed

Genius eSource Data

solution

Create eCRFs

Capture Patient

Source Data

On-site

Validation

SDV & Query CRF

Review Source

Enter Patient

Data in the eCRF

Data Management

Create

Source Data

Create Independent

eSource Data Storage from

the eCRF

Genius eSource™

Uploading of “electronic

cerified copies” of

patient’s Source Data

while entering Data into

the study eCRF

Data Management

Traditional EDC vs Genius eSOURCE™

TR

AD

ITIO

NA

L E

DC

Gen

ius eS

OU

RC

E™

Site Activity

Exom Activity

Remote &

Central Monitoring

Review Source

Traditional EDC vs eSOURCE : Timelines Comparison

TRADITIONAL EDCWeek 1 Capture subject data by hand

Week 1 - week 3 Time for data entry into an EDC system

Week 2- week 10 Time for source data verification by CRA and review by Data Manger

Genius eSOURCEDay 1 Entry of subject data directly into the mobile eSource/eCRF via a tablet

Day 1 Data availability into the eSource Data Storage and study database

Week 1 Remotely verification and review of Source data ,documents and query

generation by CRA and Data Manager

Traditional EDC vs eSOURCE :

Metrics Comparison

eSource can do in minutes a process that takes weeks with traditional EDC

Delivering cleaner data and faster helps to :

• Reduce data queries by up 70%

• Cut monitoring time by nearly 40%

• Cut site monitoring costs by nearly 70%

Benefits of Genius eSOURCE™

Encourages entering

source data during a subject’s

visit, where appropriate

Facilitates remote

monitoring of data

Promotes real-time access for

data review

Facilitates the

collection of accurate and

complete data

Reduces significantly the number

of on-site monitoring

visits

Reduces the time spent

by the investigator during the on-site visit

Accelerates SDV and data

cleaning

Reduces the time from

LPO to database

lock

Value-Added and Quality CRO Services

Full Value-Added Services

• STUDY FEASIBILITY

• CLINICAL TRIAL APPLICATIONS

• GLOBAL PROJECT MANAGEMENT

• SITE MONITORING

• CLINICAL DATA MANAGEMENT

• STATISTICAL SERVICES

• PHARMACOVIGILANCE

• QUALITY ASSURANCE

• CLINICAL SUPPLIES MANAGEMENT

• LABORATORY SUPPORT SERVICES

Therapeutic Areas Expertise

Oncology & Hematology

Cardiovascular & Metabolic

Diseases

Central Nervous System (CNS)

Disorders

Rare Diseases

Respiratory

Infectious Diseases

Urology

Gastroenterology

Critical care

Immunology

Exom’s Clinical Research Professionals

Share the passion for

quality and performance

through the digital

innovation of working

pocesses

1

Hold a solid expertise

and experience (average

6-7 years) in clinical trials

conduct

2

Establish an international

network of validated and

qualified partners (Exom

Alliance) , trained to

Exom’s technologies and

processes

3

Exom Alliance provides an established partner organization,

active across the whole of Europe and USA

Documented and

significant

experience in

clinical trials on

both drugs and

medical devices

Appropriate

education and

updated

trainings

Quality Risk

Management

& Monitoring

Regular workload,

performance and

quality assessment

by a corporate Site

Monitors’ Manager

Exom’s SOPs ,

Procedures

and

Technology

All centralized

study documents

and data on

cloud server

repositories

▪ Medical, Regulatory & Operational expertise

▪ Reliable people, you can count on

▪ Disruptive Digital Technology that enables higher

quality, performance and transparency

▪ Flexibility and dedication of a medium-sized CRO

▪ Clinical trials in Europe & USA

▪ Competitive service prices

▪ Risk Sharing agreement

Why working with us ?

Conclusions

We shall not expect that things will change

… if we keep doing the same things !

(Albert Einstein)

Final

Considerations

• Only Life Sciences companies that

recognize that implementing

digital solutions is not as simple as

installing new technologies but

really a fundamental change in the

way they do business, will get the

most from their new system for

years to come

• If you are among those life science

companies , Exom will be your

“Preferred Partner”

We look forward to hearing from You

www.exomgroup.com