brecht claerhout — custodix nv
TRANSCRIPT
Brecht Claerhout — Custodix NV
THE INSITE PLATFORM
Accelerating Clinical
Research in Europe
“From a technical perspective, InSite is a
platform that enables reuse of EHR data in a
secure and trustworthy way. But InSite is also
about shaping a new ecosystem dedicated to
accelerating clinical research.”
The InSite Platform
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EHR4CR Electronic Health Records
for Clinical Research
• IMI project 2011 – 2016
• 35 partners (10 Pharma Companies, 11
major hospitals)
• 12 studies, de-identified data from >500k
patients
• InSite builds upon the outcome and
community of EHR4CR aiming to realize
the project’s vision
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Study design
EHR data
extraction for
reporting and EDC
Pharmacovigilance,
outcomes research, …
Site
identification
Patient
recruitment
…
Reusing Data for Clinical Research
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EHR CDW
InSite
Local Install ETL
Central
Platform
NO patient data
leaves the hospitals Site dependent
process
Local InSite
applications
Secure access
for researchers
InSite – Technical Overview
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InSite
Local Install
Central
Platform
Formalised
eligibility criteria
• Counts of patients
• Recruitment progress
Audit log of
queries locally
available
Trial candidates suggested
to investigators
InSite – Technical Overview
• Operational pan-European platform
of clinical sites giving access to
millions of patients for research in
close to real time
• Guarantee patient privacy by
respecting hospitals as data
guardian
• Provide clear benefits to all
stakeholders involved: patients,
hospitals, researchers
Creating a
sustainable ecosystem
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Novel Business Model
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Pharma
Academic
Sponsors
CROs
• InSite is a matchmaker between researchers and data
providers
• InSite does not interfere with agreements between
sponsors and sites participating in trials
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Design better trials and reduce
costly corrective measures Attract More Clinical Research
Get Free Access to Software
Always control how your data is
used
Optimise clinical site identification
Achieve recruitment targets more
quickly
Improve the overall clinical trial
process
Steer the future of data reuse
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InSite Central Platform – aggregated
information for conducting research
InSite Clinical Site – detailed data
exploration for care givers
• Start building a network of hospitals
• Further validate and improve technology
• Refine the rules of engagement for a
sustainable ecosystem
• Engage with European Institute for
Innovation through Health Data which
aims to govern the EU data re-use
ecosystem
Champion Programme
2016 – 2017 (Q1)
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The Champion Programme
A multi-stakeholder collaboration
aiming to accelerate and ensure the
future of clinical research in Europe
CROs
Hospitals
i~HD
• Aim to include 15 - 30 hospitals or
hospital clusters
• Partner with sites from at least 7
European countries
• Reach out to the US
• Build technical and service oriented
partnerships
Building the
Ecosystem 2016 – 2017
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The Champion Programme is
still open to hospitals
Hospital profile
• Good EHR coverage
• Large % of coded data
• Good data accessibility
• Commitment to participate
Pragmatic approach
• Minimal burden on hospital
• Sufficient starting point: diagnosis,
procedure, lab, medication
• Connect to improve — let InSite
drive data quality improvement
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2
Introduction to
the programme
Technical
readiness check
Planning
4
1
Implementation
3
Continuous data
quality improvement
Tailored Connection Plan per Site
• Coverage
• Scope
• Freshness
• Contacting the first wave of
hospitals
• Completed the first agreements
with hospital partners.
Current Status
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“InSite aims to become the central
hub where sponsors, care givers and
service providers meet up to initiate
clinical trials.”
Beyond the Champion Programme
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Hospitals Clusters
Regional
networks
National
networks
Growing
the
network
Third Party
Service Providers
Extending
the
services
Platform
Services
Primary
care
Research
networks
Expanding
RWD
mHealth
Accelerating
growth
Technical
partners
Brecht Claerhout
www.insiteplatform.com
Thank You
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InSite is a service provided by Custodix NV
Kortrijksesteenweg 214 b3 — 9830 Sint-Martens-latem — Belgium