the human digital cro - exom group...the digital solution for clinical trials complexity. ......
TRANSCRIPT
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At a Glance PresentationJune 2017
The Human Digital CRO
Edition January 2018
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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
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Genius SUITE®Cloud & Mobile Clinical Trials
The digital solution for clinical trials complexity
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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)
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Our Technology Partners
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Cloud & Mobile
Clinical Trials
All study activities through a
«Study Portal» and a tablet
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Standard Study Portal functionalities
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The solution: Genius RIBAM™
How to perform a Digital Quality Risk Management ?
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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)
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• 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
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Genius RIBAM™ How it works
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Genius RIBAM™ : central monitoring of
critical sites in details
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Genius RIBAM™
Benefits
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Genius RIBAM™ Metrics
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To reduce time, resources and costs in study documents management and to be inspection ready
Genius eTMF™16
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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
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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
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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
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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.)
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Genius ENGAGE®the electronic Informed Consent
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CRF Health - State of eConsent 2017 Report
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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
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The solution: moving from
paper Consent to eConsent
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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
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Why moving to the
electronic IC ?
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What is the process for eConsent at sites?
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Genius ENGAGE™is an unique solution for the electronic Informed Consent (eIC) since it is integratedwith the eTMF and the eCRF
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Genius ENGAGE™includes a patient’s quiz for testing his comprehension of the content of the IC
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Genius ENGAGE supports both the manual signature of the paper ICF as well as the electronic signature
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The electronic signature process is protected by a PIN code delivered automatically by the system to the patient’s mobile phone
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The patient will sign the ICF by typing his name or writing it with the finger on the tablet
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Genius ENGAGE™ provides an audit trails of the informed consent workflow
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Paper IC vs the Electronic IC
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CRF Health - State of eConsent 2017 Report
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Performance and Metrics of the eConsent
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The eSource Data
Revolution
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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
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Genius eSource Data
solution
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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
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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
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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%
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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
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Value-Added and Quality CRO Services
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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
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Therapeutic Areas Expertise
Oncology & Hematology
Cardiovascular & Metabolic
Diseases
Central Nervous System (CNS)
Disorders
Rare Diseases
Respiratory
Infectious Diseases
Urology
Gastroenterology
Critical care
Immunology
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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
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Exom Alliance provides an established partner organization,
active across the whole of Europe and USA
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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
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▪ 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 ?
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Conclusions
We shall not expect that things will change
… if we keep doing the same things !
(Albert Einstein)
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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”
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We look forward to hearing from You
www.exomgroup.com