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TriNetX, InSite Unite to Establish World’s Largest Clinical Research Network

2 Apr 2019

Acquisition of Belgium-based Custodix Promises to Bring New Pharmaceutical-Sponsored Clinical Trials to Healthcare Organizations Throughout Europe.

TriNetX, Inc., the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), today announced the acquisition of Custodix NV and its InSite network, a European-based provider of services for clinical trial design, patient feasibility, and enabling workflow for patient recruitment. The financial details of the transaction were not disclosed.

Custodix’s InSite network is active in 12 countries throughout Europe and complements the existing TriNetX European footprint. In addition to the US and Europe, TriNetX is powered by an impressive network of healthcare organizations (HCOs) globally, including Japan, Singapore, Malaysia, Philippines, India, Israel, and Brazil.

The acquisition comes following TriNetX’s recent Series D funding raised in part to support the company’s international expansion. The unity establishes the largest research network in Europe and presents existing InSite healthcare organizations with increased access to clinical trial opportunities. TriNetX’s customer base includes 29 industry partners, consisting of 11 of the largest pharmaceutical companies including Novartis, Sanofi and Pfizer, and top contract research organizations (CROs) including Syneos and ICON. TriNetX has been used to analyze over 13,000 protocols and has presented over 3,400 trial opportunities to its HCO members.

"This is a breathtaking unification of two extremely compatible research networks," said Gadi Lachman, TriNetX CEO. "The two companies launched in separate geographies, but share a commitment to strong compliance, governance, and a global vision for clinical research. We now offer the world’s largest platform for clinical research, providing a more powerful resource for pharma companies and healthcare organizations, and more hope for patients in need. This expansion gives us additional local leadership, regional support, and increased resources in the European market."

The Custodix addition quadruples the size of the current European TriNetX staff and establishes an EU headquarters as a resource base to launch further expansion in Europe and Asia. Custodix’s CEO Brecht Claerhout will become TriNetX’s Managing Director/Europe and the division—to be known as InSite, a TriNetX company—will drive the combined organization’s European strategy and execution going forward.

"This deal is exciting news for the healthcare organizations in our InSite network," said Brecht Claerhout. "We share similar values to TriNetX, which will enable us to continue collaborating with the hospital community, service our customer base as we always have, and bring new clinical trial opportunities to researchers and their patients."

The InSite platform is an initiative of Custodix that was named one of the most promising SME health initiatives in 2016 by the European Commission and in 2018, received the Clinical Informatics News European Innovation Award. InSite builds on the outcome of several international research projects and in collaboration with the pharmaceutical industry through the EHR4CR project as part of the Innovative Medicines Initiative (IMI) research program.

About TriNetX

TriNetX is the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence. TriNetX combines real time access to longitudinal clinical data with state-of-the-art analytics to answer complex research questions at the speed of thought. The TriNetX platform is HIPAA and GDPR compliant. For more information, visit TriNetX at or follow @TriNetX on Twitter.

About InSite

InSite is a private initiative determined to define and realize a sustainable eco-system for real-world data-driven clinical trial design and execution. InSite is building a pan-European network of clinical sites that want to maximize their involvement in clinical research with academic and industry research organizations, and create a win-win situation for industry, academic researchers, hospitals and patients. For more information, visit InSite at

Media contact

Jennifer Haas
+1 (857) 285-6052

InSite was awarded the Clinical Informatics News European Innovation Award 2018

17 Oct 2018

The winner of the inaugural Clinical Informatics News European Innovation Award was announced on Wednesday at the Summit for Clinical Ops Executives (SCOPE)-Europe in Barcelona, Spain. The prize was awarded to Custodix for their InSite platform.

The European Innovation Awards program seeks to recognize outstanding examples of applied strategic innovation—partnerships, deployments, and collaborations that manifestly improve the clinical trial process.

"Our goal in creating this new award is to recognize the projects that raise the bar on innovation in clinical trials," said Allison Proffitt, Clinical Informatics News’ Editorial Director. "This year’s competitive field of entries further proves the dedication of our community and industry to improving the clinical trials process for both patients and researchers."

This year’s winner, Custodix, is honored for their InSite platform, which enables the secure reuse of EHR data in clinical research.

"Patient recruitment is one of the primary bottlenecks in the clinical trial process," Custodix wrote in their entry form. "Traditionally, it is hampered by ineffective communication between sponsors and sites, and a lack of data-driven insight in the patient population."

InSite addresses these challenges by establishing a new communication path between hospitals and researchers, and enabling the secure reuse of EHR data in clinical research. Using InSite, the patient recruitment process is vastly improved, the company believes.

Based on anonymized and aggregated real-world patient data, trial sponsors get immediate feedback on the effect of inclusion and exclusion criteria on a study’s recruitment potential in a HIPAA and GDPR-compliant way. This results in high-quality protocols and limits the need for costly amendments in later stages.

Judges for the 2018 awards included Silke Strommenger, Bayer AG; Phillips Kuhl and Micah Lieberman, Cambridge Healthtech Institute; Allison Proffitt and Ben Ross, Clinical Informatics News; and other industry experts.


Roche: open-sourcing healthcare

14 Sep 2018

In a new blog post, Roche gives an overview of how they want to turn Big Data into life-changing healthcare through partnerships. One of its flagship examples is the EHR4CR project that lies at the inception of the InSite platform.

The hunt for innovative new ways to improve how clinical trials are conducted is always on, to help ensure patients can access medicines through them. The EHR4CR platform not only helps match patients to clinical trials to ensure they get early access to the most promising advances in medicine, the platform is also a powerful tool to help fine-tune the details of a clinical trial. This helps make the trial process and execution smoother and also helps save precious time.

Read more

EHR2EDC: a revolution in collecting and using health data in clinical research

21 Jun 2018

The EHR2EDC project is the first international project striving to enable the automated collection of patient data from electronic health records (EHR) in clinical trials. The automatization will not only improve data quality, but also reduce investigator workload and its associated costs. This improved efficiency can revolutionize the way clinical trials are conducted and will stimulate biomedical research.

The research builds on the EHR4CR project, from which InSite originated. It is executed by a consortium of academic and industrial partners, including Custodix. The results will be incorporated as a new InSite service, capturing data from EHRs to electronic case reports. Funding is provided by EIT Health, a knowledge and innovation community established by the European Institute of Innovation & Technology. Recently, they have featured EHR4CR on their website as one of the breakthrough innovations they are supporting.

Read the full article here or find out more about EHR4CR here

© EIT Health

Inspiring other European Healthcare innovators

5 Jun 2018

This week, the Health Think Tank of the European Institute for Innovation & Technology (EIT) organized a round table in Barcelona on the use of existing big data to improve healthcare.

This Think Tank is a forum of experts and thought leaders cooperating to shape the future of healthcare in Europe. Through actionable conclusions they aim to ensure that innovation reaches the citizens and patients who need it most.

At the meeting, Dr. Pablo Serrano of the University Hospital 12 de Octubre (Madrid, Spain) presented his experiences with InSite to illustrate the value of using data in clinical research. As a company with its origins in a European research project, we hope to inspire others to leverage the available funds and know-how to create practical solutions improving the (quality of) life of patients.

Spreading the word!

21 Mar 2018

Our CEO was invited to speak at the Medidata NEXT conference in Frankfurt. He shared his insights on how Electronic Health Records can transform the clinical research landscape. While there is a lack of conformity across EHR solutions, they also represent a rich source of data that can improve study conduct, site and patient recruitment. By unlocking these data, InSite aims to streamline clinical research and bring innovative treatments to the patient faster and at a lower cost.

Could EHRs Boost Clinical Trial Recruitment?

6 Mar 2018

"Patient recruitment for clinical trials is commonly accepted to be a herculean task. A new platform could make the process a lot quicker and easier – and, crucially, not at the expense of data privacy."

Ross Davies - eyeforpharma

Eyeforpharma has published a feature article on the EHR4CR project from which the InSite platform originated. In the article, the project coordinator Mats Sundgren (Astra Zeneca) and one of the project partners, Juuso Blomstra (Turku University Hospital), discuss the project’s inception, InSite’s benefits, its strict adherence to privacy regulation and how the Champion program is making great progress in building the hospital network.

Read the full article on the eyeforpharma website to learn more, or attend Mats Sundgren’s talk at the Real-World Evidence and Access Europe 2018 conference.

2nd InSite User Group Meeting: from plans and ambitions to results!

19 Feb 2018

On February 8th, we welcomed more than 60 representatives from hospitals, pharmaceutical companies and CROs from all over Europe for the 2nd InSite User Meeting. The conference brought together InSite's partners and those interested in joining the network to share their insights and exchange best practices on the use of real-world data.

We would like to thank our speakers and all those who attended for making this day a success. In one year's time we went from presenting ambitions and plans to impressive results making InSite's power tangible.

The meeting highlights

IRST (Italy) and Clinica Universidad de Navarra (Spain) presented the initial results of their pilot recruitment studies demonstrating the ability to find more eligible patients in minutes instead of weeks!

Our pharma partners shared their perspective on InSite’s benefits. The platform enables bringing new therapies to patient faster at a reduced cost, for example by designing protocols more efficiently and preventing costly amendments, thanks to the ability to test them on real world data.

Turku University Hospital (Finland) has joined the pilot program for academics. We are actively recruiting additional universities that want to participate in this program, so be sure to get in touch if you are interested!

Other presentations highlighted the importance of good data recording practices. Whether for use in trials, or to optimize patient treatment plans, high-quality data is imperative to prevent certain biases and draw the right conclusions. Joibn InSite and leverage Custodix’ expertise to optimize your data quality, mapping it to international (European) standards, free of charge.

An IT workshop allowed some attendees to dive deeper into the technical aspects of the platform. In parallel, a Q&A session stimulated the discussion between all partners on how they would like to see the platform evolve. An important driver of innovation is the EHR2EDC project, expanding InSite's applications to trial execution, in which a sneak peek was given.

We look forward to welcoming you to the next edition!

InSite listed as one of the IMI success stories

1 Nov 2017

In an interview with IMI (Innovative Medicines Initiative), Mats Sundgren from pharmaceutical company AstraZeneca, explains how the EHR4CR (Electronic Health Records Systems for Clinical Research) project enables scientists to find suitable patients by searching millions of medical records while keeping personal data secure. He refers to InSite as one of the key successes of the project, concluding with "It’s really new, but it will have a big impact".

Read more on the IMI website.

Looking back on a successful first InSite User Group Meeting

12 Jun 2017

We look back with pride to our first InSite User Group Meeting in May. 47 participants coming from 20 hospitals from all over Europe joined us in Brussels to exchange ideas about how InSite can change their way of working.The questions raised and new opportunities created by the re-use of Real World Data were the topic of the presentations of that day.

Prof. Schindler (MHH, Hannover, Germany) and Dr. Diaz (Fundación HM, Madrid, Spain) opened the sessions with a general overview of the benefits of our platform. They are amongst the first hospitals connected to the platform and thus have a lot of experience to share. An important item was the reflection on data protection and the security of the privacy of our platform by Prof. Krugel (Germany). Tangible cases of the potential use of the cohort tool were presented by Dr. Legrand (Healthcareconsult, Belgium). More examples of how the platform can be used to analyze the patient population were provided by Dr. Serrano (Hospital 12 de Octobre, Madrid, Spain). Dr. Nanni (IRST, Meldola, Italy) presented the results of a retrospective validation exercise that showed that the InSite platform managed to identify 100% of patients that were previously enrolled in a (past) clinical trial.

We ended the day with a panel discussion. Pharma representatives highlighted the point of view of the pharma on a complete new way of conducting clinical trials using the InSite Real World Data platform. It has proven to be a valuable opportunity to interact, connect and exchange.

Things are moving fast with InSite...

9 Feb 2017

As of February, 6 hospitals in 4 different European countries are live on the InSite network. 2017 is the year that InSite went live and will be a year of substantial growth as we are determined to expand the network to 30 sites by the end of the year.

Recognised as One of the Most Promising Health SMEs in Europe

9 Jun 2016

Custodix won 2nd prize in the EU SME eHealth Competition 2016 in Amsterdam in the Champions category with the InSite platform business approach. The eHealth Competition is an initiative that rewards the best eHealth solutions produced by SMEs in Europe ( The competition is endorsed by the European Commission. In the 2016 edition there were 112 entries, of which 16 finalists competed in Amsterdam in front of an international jury.

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