The InSite Champion Programme

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Info Sheet:
The InSite Champion Programme
The InSite Platform
InSite is a private initiative determined to define and realise a sustainable eco-system for Real World
Data driven clinical trial design and execution. It aims to build a pan-European network of clinical sites
that want to maximise their involvement in clinical research with academic and industry research
organisations, and as such create win-situation for industry, academic researchers, hospitals and
patients.
InSite builds upon the outcome of several international research projects aimed at accelerating
research through re-use of care data (EHR, primary care, Personal Health Records, …) and more
specifically on the collaboration with the pharmaceutical industry through the EHR4CR project
(www.ehr4cr.eu - Electronic Health Records for Clinical Research) as part of the IMI (Innovative
Initiative Medicine) research program (www.imi.europa.eu).
The InSite platform is an initiative of Custodix NV (www.custodix.com), endorsed by the EHR4CR
consortium and “The European Institute for Innovation through Health Data” (www.i-hd.eu).
Uniqueness of the InSite Initiative
InSite is the first European multi-stakeholder collaboration aiming to leverage Real World Data on a
large and systematic scale for clinical research. The initiative is unique in its approach to data
protection compliance and sustainability model. InSite is designed in a way that patient level data
remains at all times under control of the lawful data guardians (i.e. hospitals). As a matter of fact,
patient data never leaves the hospital environment (for more detailed information, cf. the “InSite
platform Security & Privacy” Info Sheet). Usage of the platform is strictly restricted to use for research
purposes.
InSite distances itself from data exploitation models where third parties buy patient data from data
sources and market it beyond the control of the original data guardians. The platform operates
according to a different economic model in which it acts as a matchmaker between data providers
and research organisations (not interfering with their bilateral agreements).
The InSite Services
The InSite roadmap includes a multitude of services, including:
 Trial Design - enabling protocol testing with real world data rather than with guestimates.
 Site Selection – identification of potential trial sites.
 Patient Recruitment - speeding up recruitment by making EHR data searchable for
investigators and establishing a unified communication path between sponsors and sites.
 EHR data extraction - Facilitating EHR data extraction for applications used during trial
execution (e.g. prefilling of CRFs and of SAE reports).

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Connecting to InSite encompasses the installation of InSite Node software connected to an InSite
compatible data warehouse in a hospital (see further for the connection process). If no data
warehouse is available, one will be installed together with the InSite Node software. The InSite Node
software packs a number of applications which can be used exclusively within the hospital, such as a
patient recruitment tool, a cohort selection tool, a patient browser. We intend to further extend the
software bundle available within the hospital.
It is possible to extend the InSite data warehouse for internal use (e.g. incorporating administrative
info in order to generate benchmarking reports).
The InSite Operational model
The InSite platform aims to act as a matchmaker between hospitals and sponsoring research
organisations. The platform is therefore open to any research organisation (be it CRO, pharma
company, academic institution or independent research group) and will not interfere with the study
conduct contract that is made between the site and sponsor.
Hospitals participating to InSite agree to have their InSite clinical data warehouse available for trial
design services. The return for joining the platform comes in multiple forms:
Participating clinical sites will
be able to attract more
clinical research.
Participating sites get access
to software at favourable
conditions.
InSite offers the possibility to
take part in the Real World
Data revolution without risk.
 Better patient care
More patients get access
to innovative trial drugs
and care pathways at no
additional cost to the
hospital.
Physicians are more up to
date with medical science.
 Increased revenue
In the current economic
environment, hospitals
need to search for new
revenue streams, InSite
helps to attract more trials
and thus generate
additional revenue.
 Increased efficiency
InSite provides tools for
use within the hospital to
speed up identification of
trial candidates.
 Free access to tools
Participation to InSite
includes free access to
tools to explore and
analyse their patient data.
Champion hospitals (cf.
Champion Programme)
will get free access to
premium versions.
 Data Warehousing
Sites can extend the InSite
data warehouse for their
own applications.
 Riskless innovation
Participating in new trials
and connecting with peers
in the community results in
greater visibility in the
scientific community.
 Improved data quality
The platform stimulates
hospitals to focus on data
quality. Improved
monitoring, benchmarking,
reporting drives
optimization of patient care
and improved internal
management.
 Remain in control
Contrary to other
initiatives, with InSite,
hospitals remain in control
of their data. InSite merely
brokers between sponsors
and data custodians.

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When sites engage into a trial with a sponsor, they will do so through a bilateral contract. InSite does
not (and does not intend to) interfere with the established processes and reimbursement agreements
between sponsors and sites.
The Champion Programme
The Champion Programme is a first step in building that pan-European network. It will run in 2016 and
2017 as collaboration between early-adopters in industry and hospitals.
The objectives are to start building a network and community of hospitals open to data re-use for
research, to further validate and improve the technology and to define (refine) the business model
(creating a win for all stakeholders) and governance rules in cooperation with the European Institute
for Innovation through Health Data (i~HD).
In order not to lose focus, the Champion programme will be mainly dealing with further evolving the
trial design and patient recruitment services in 2016. Sites that support the idea of a community of
research oriented hospitals and thus join the Champion Programme will be able to steer the direction
in which this initiative evolves and will be able to interact closely with sponsors. Additionally, early
adopter champions will enjoy a number of benefits beyond the champion programme (e.g. free access
to premium versions of software).
Getting Involved: The Connection Process
Hospitals are invited to the Champion Programme by one of the participating champion research
organisations or Custodix. Hospitals can join at no cost although they are expected to contribute a
minimum in-kind in the form of giving input to the Custodix technical teams and providing the local IT
environment for installing the InSite Node Software.
In short, connecting to the network is a 4-stage process:
 Stage 1: expression of interest
 Stage 2: site readiness assessment
 Stage 3: planning of roll-out and signing of a partner agreement
 Stage 4: implementation of InSite in the hospital
During the site assessment (stage 2) the “readiness” of the hospital for joining InSite is evaluated by
Custodix in collaboration with hospital staff. The goal is to determine how structured diagnosis,
procedure, lab and medication data can be made available for re-use within the hospital. The result
of this assessment is a roadmap for site connectivity. It is important to note that we do not expect
that large volumes of up-to-date (zero-day) validated data are readily available in a Clinical Data
Warehouse in the hospital. A growth path for iteratively improving data quality, volume and freshness
will be defined.
Experience shows that typically available clinico-administrative data (exports) in combination with
LIMS data and a medication records provide already a valuable starting point.
During the whole connection process the burden for the hospital is reduced to a minimum, tasks are
as much as possible performed by Custodix. Ideally, data format specifications and sample data can

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be made available by the hospital, allowing Custodix to design the data input pipeline with minimal
involvement of hospital personnel.
More detail on the connection process can be found in the InSite “Introduction to Site Connectivity”
presentation.
What to expect after the Champion Programme
The Champion Programme serves at proving the value of Real World Data for clinical research and the
InSite technology on a wide scale. The initiative will be jointly evaluated by the group of Efpia
(European Federation of Pharmaceutical Industry Association) companies and CROs part of the
programme, in cooperation with the i~HD institute.
Next to technical evaluation, a clear objective of the Champion Programme is to refine the eco-system
dynamics (economic and governance related aspects) leading to sustainability. This could include
incentive programmes such as reimbursement of connected sites based on their data quality after the
Champion Programme.
After the Champion Programme, the InSite platform will open up to all hospitals meeting the technical
requirements and to all sponsors, both commercial (pharmaceutical companies) and academic (at
reduced rates). Champion hospitals will automatically be invited into this wider commercial
deployment of InSite and will be able to benefit as early supporters from a number of advantages over
those who join later on. Benefits will include such things as e.g. free access to the premium version of
local software modules.
The current established champion user group consists of AstraZeneca, Roche, Sanofi, Janssen and
ICON plc. Additionally Amgen, Bayer, GSK and Boehringer-Ingelheim plan to join this group. These
companies support the InSite initiative during 2016-2017 in rolling out to 15-30 champion hospitals
across Europe and will drive validation of the platform.
The clear intent of the Champion Programme, aligned with the vision of the EHR4CR project, is to
create momentum for creating a sustainable network of hospitals, further developing a reliable
trustworthy set of platform services for both the public and private sector, growing a user base and
expanding the collaboration with new service providers under governance of the European Institute
for Innovation Through Health Data.
The Champion Programme aims to be a stepping stone towards a new model of cooperation between
care providers and clinical researchers and will do so by providing further evidence of the benefits that
the InSite platform can bring both to care/hospital and pharmaceutical oriented stakeholders.
For further questions on the Champion Programme, please contact:
 Brecht Claerhout (brecht.claerhout@custodix.com) – Tel. +32 9 210 78 90
 David Voets (david.voets@custodix.com) – Tel. +32 9 210 78 90
 Champion Industry Group/EHR4CR: Mats Sundgren (mats.sundgren@astrazeneca.com) –
Tel. +46 70 626 3087