IDDI The Highest Standard in Clinical Data Science IDDI ‘experience: 16 FDA/EMA market approvals - 500+ trials to date.

IDDI (International Drug Development Institute) provides Biostatistical and eClinical Services for phase I - IV clinical trials offering trial design - randomization (IWRS) - data management - biostatistics. IDDI combines expert methodology in Biostatistics (including Biomarkers validation and Support to IDMCs) with innovative integrated technology (eClinical suite of made-to-measure secure we

b systems: IWRS integrated to EDC) to optimize the design and conduct of clinical trials. IDDI is headquartered in Belgium with offices in the US (Boston, MA and Raleigh, NC)

IDDI Clinical Data Expertise leads to FDA/EMA Approval thanks to high QUALITY RISK MANAGEMENT

IDDI aims to limit risks for sponsors during the entire clinical trial process:

At the design stage: by identifying the optimal trial design
At the planning stage: by identifying key clinical data to be collected and analysed in real-time
At the conduct stage: by using web-based integrated systems to access, control and validate the data
At the analysis stage: by using advanced statistical methodology
At the report stage: by being strictly compliant to regulatory requirements

Our experts offer flexible and innovative solutions for clinical research and are not afraid to challenge the status quo. We manage simple and complex clinical trials including adaptive trials and have all our operational systems and processes adaptive.

• The 3 Pillars of IDDI

Methodology, Technology and People, are the three 'pillars' of our highly skilled clinical research service offering: eClinical and Biostatistical services for clinical trials since 1991. Best in class biostatistical expertise

⇒ Focus on the optimal design and using the clinical data that is really needed
Cost-effective, user-friendly integrated IWRS/EDC

⇒ Accelerated study start-up time
Highly skilled people demonstrating flexibility & continuity. Accelerated timelines in a flexible manner

⇒Leads to Successful Regulatory Submission

𝐅𝐫𝐨𝐦 𝐂𝐨𝐦𝐩𝐥𝐞𝐱 𝐃𝐚𝐭𝐚 𝐭𝐨 𝐅𝐃𝐀 𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥: A biotech developing a treatment for Geographic Atrophy needed to present consistent,...
09/06/2026

𝐅𝐫𝐨𝐦 𝐂𝐨𝐦𝐩𝐥𝐞𝐱 𝐃𝐚𝐭𝐚 𝐭𝐨 𝐅𝐃𝐀 𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥: A biotech developing a treatment for Geographic Atrophy needed to present consistent, regulator-ready evidence across multiple trials with different designs.

They needed more than good data.
They needed clear, regulator-ready insights across the entire program.

led the Integrated Summary of Safety (ISS) and Effectiveness (ISE), aligning datasets and applying a focused pooling strategy to support program-level conclusions—without delaying timelines.

𝐓𝐡𝐞 𝐨𝐮𝐭𝐜𝐨𝐦𝐞?
✔ FDA approval
✔ EMA MAA accepted two weeks later

When data complexity increases, the right statistical strategy becomes critical.

👉 Read the case study: https://go.iddi.com/l/1100512/2026-05-27/35x41z?utm_source=linkedin&utm_medium=organic_social&utm_campaign=ophthalmology_LinkedIn&utm_content=linkedin_post_4
👉 Or get in touch to discuss your next submission: https://iddi.com/contact/

Congratulations to the IDDI runners and walkers who participated and crossed the finish line of the 20km de Bruxelles / ...
04/06/2026

Congratulations to the IDDI runners and walkers who participated and crossed the finish line of the 20km de Bruxelles / 20 km door Brussel last Sunday!! A great moment of team spirit, energy, and perseverance—values that also drive us every day in . Well done!

02/06/2026

Cancer prevention trials often face a fundamental challenge: the most meaningful clinical outcomes can take years to observe. So how can sponsors make earlier, informed development decisions without compromising scientific or regulatory confidence?

Marc Buyse explains how helped support earlier, data-driven decision-making in a Lynch syndrome trial by:
✔ Linking early measurable endpoints to long-term outcomes
✔ Applying interim analyses throughout the study
✔ Enabling more efficient trial design in a complex oncology setting

The result: earlier insights that can help reduce development risk and support better decision-making in cancer prevention trials.

26/05/2026

𝐖𝐡𝐚𝐭 𝐬𝐞𝐩𝐚𝐫𝐚𝐭𝐞𝐬 𝐞𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐭 𝐨𝐩𝐡𝐭𝐡𝐚𝐥𝐦𝐨𝐥𝐨𝐠𝐲 𝐭𝐫𝐢𝐚𝐥𝐬 𝐟𝐫𝐨𝐦 𝐝𝐞𝐥𝐚𝐲𝐞𝐝 𝐨𝐧𝐞𝐬?

Often, it comes down to the decisions made before the trial even begins. From study design and recruitment strategy to data standardization and regulatory alignment, every stage impacts trial quality and speed.

Our latest guide outlines 5 data-driven steps teams can take to reduce risk, improve reliability, and keep ophthalmology studies on track. See what others don’t: https://iddi.com/resources/5-data-driven-steps-for-successful-ophthalmology-trials/?utm_source=linkedin&utm_medium=paid_social&utm_campaign=ophthalmology_linkedin&utm_content=boosted_post_2

20/05/2026

Clinical research is never the work of one person alone. Behind every trial are people collaborating across disciplines, solving challenges together, and contributing their expertise to help move research forward.

In our final Clinical Trials Day spotlight, Neil Baron reflects on the many individuals behind every dataset, every decision, and every step toward progress.

This , we celebrate the people advancing research together—and thank everyone helping turn research into impact.

18/05/2026

Clinical trials are complex, but when the right people, processes, and data come together, meaningful progress happens. In our latest spotlight, Tara Kervin shares how operational ex*****on & data science working hand in hand can help research move faster for patients.

14/05/2026

💉𝐍𝐨𝐭 𝐚𝐥𝐥 𝐜𝐨𝐧𝐭𝐫𝐢𝐛𝐮𝐭𝐢𝐨𝐧𝐬 𝐭𝐨 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐡𝐚𝐩𝐩𝐞𝐧 𝐟𝐚𝐜𝐞-𝐭𝐨-𝐟𝐚𝐜𝐞 𝐰𝐢𝐭𝐡 𝐩𝐚𝐭𝐢𝐞𝐧𝐭𝐬. 𝐒𝐨𝐦𝐞 𝐡𝐚𝐩𝐩𝐞𝐧 𝐛𝐞𝐡𝐢𝐧𝐝 𝐭𝐡𝐞 𝐬𝐜𝐞𝐧𝐞𝐬—𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐩𝐫𝐞𝐜𝐢𝐬𝐢𝐨𝐧, 𝐩𝐫𝐨𝐠𝐫𝐚𝐦𝐦𝐢𝐧𝐠, 𝐜𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧, 𝐚𝐧𝐝 𝐝𝐚𝐭𝐚.

In our second Clinical Trials Day spotlight, Françoise Dissassuca shares how transitioning from an academic and hospital environment into clinical data management opened a new way to contribute to research with real patient impact.

“Even behind the scenes, your work really matters. You’re part of something bigger.”

This , we celebrate the people whose expertise helps move research forward—and turn purpose into possibility.

Endpoint variability, imaging inconsistency, and recruitment challenges are common in   trials, yet they are not always ...
13/05/2026

Endpoint variability, imaging inconsistency, and recruitment challenges are common in trials, yet they are not always accounted for in study design. This oversight leads to problems later on, such as noise, delays, and increased risk.

At , we bring into study design early, where decisions have the biggest impact. Take a closer look: https://go.iddi.com/see-what-others-dont-in-ophthalmology-clinical-trials?utm_source=linkedin&utm_medium=paid_social&utm_campaign=ophthalmology_linkedin&utm_content=boosted_post_2

🚀 The wait is over!  's Tara Kervin is presenting at 10:50am: "𝐖𝐡𝐞𝐧 𝐭𝐡𝐞 𝐓𝐫𝐮𝐭𝐡 𝐈𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐃𝐚𝐭𝐚: 𝐈𝐧𝐝𝐞𝐩𝐞𝐧𝐝𝐞𝐧𝐭 𝐁𝐢𝐨𝐦𝐞𝐭𝐫𝐢𝐜𝐬 𝐟𝐨𝐫...
12/05/2026

🚀 The wait is over! 's Tara Kervin is presenting at 10:50am: "𝐖𝐡𝐞𝐧 𝐭𝐡𝐞 𝐓𝐫𝐮𝐭𝐡 𝐈𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐃𝐚𝐭𝐚: 𝐈𝐧𝐝𝐞𝐩𝐞𝐧𝐝𝐞𝐧𝐭 𝐁𝐢𝐨𝐦𝐞𝐭𝐫𝐢𝐜𝐬 𝐟𝐨𝐫 𝐌𝐨𝐝𝐞𝐫𝐧 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬”. If you are attending hashtag , don't miss this insightful session and the opportunity to hear Tara share her perspective on how independent biometrics strenghthen trust, clarity, and confidence in .

And while you're there, come visit us at our booth #5, Jessica Dvotsky would be happy to connect, exchange ideas, and discuss how we could support your study.

We look forward to seeing you there 👋

07/05/2026

🚀 𝐁𝐞𝐡𝐢𝐧𝐝 𝐞𝐯𝐞𝐫𝐲 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐭𝐫𝐢𝐚𝐥, 𝐭𝐡𝐞𝐫𝐞 𝐚𝐫𝐞 𝐩𝐞𝐨𝐩𝐥𝐞 𝐬𝐨𝐥𝐯𝐢𝐧𝐠 𝐩𝐫𝐨𝐛𝐥𝐞𝐦𝐬, 𝐞𝐧𝐬𝐮𝐫𝐢𝐧𝐠 𝐪𝐮𝐚𝐥𝐢𝐭𝐲, 𝐚𝐧𝐝 𝐡𝐞𝐥𝐩𝐢𝐧𝐠 𝐫𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐦𝐨𝐯𝐞 𝐟𝐨𝐫𝐰𝐚𝐫𝐝 𝐞𝐯𝐞𝐫𝐲 𝐬𝐢𝐧𝐠𝐥𝐞 𝐝𝐚𝐲.

In the run up to we’re spotlighting the experts working behind the scenes to make sure that every decision is built on data you can trust.

Over the next few weeks, colleagues from different teams will share insights into their work, the challenges they navigate, and how their expertise contributes to better outcomes for patients.

We’re kicking off the series with Joëlle Périer, who explains why clean data isn’t something you “fix” at the end of a study — it’s built from day one through collaboration, consistency, and attention to detail.

🎥 Watch the first video below — and stay tuned for more!

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