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

 #𝐃𝐘𝐊 | 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝 𝐭𝐚𝐛𝐥𝐞𝐬 𝐚𝐧𝐝 𝐥𝐢𝐬𝐭𝐢𝐧𝐠𝐬 𝐝𝐨𝐧’𝐭 𝐚𝐥𝐰𝐚𝐲𝐬 𝐭𝐞𝐥𝐥 𝐭𝐡𝐞 𝐟𝐮𝐥𝐥 𝐬𝐭𝐨𝐫𝐲 𝐛𝐞𝐡𝐢𝐧𝐝 𝐚𝐧 𝐞𝐦𝐞𝐫𝐠𝐢𝐧𝐠 𝐬𝐢𝐠𝐧𝐚𝐥.As trial data evolves, I...
03/09/2026

#𝐃𝐘𝐊 | 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝 𝐭𝐚𝐛𝐥𝐞𝐬 𝐚𝐧𝐝 𝐥𝐢𝐬𝐭𝐢𝐧𝐠𝐬 𝐝𝐨𝐧’𝐭 𝐚𝐥𝐰𝐚𝐲𝐬 𝐭𝐞𝐥𝐥 𝐭𝐡𝐞 𝐟𝐮𝐥𝐥 𝐬𝐭𝐨𝐫𝐲 𝐛𝐞𝐡𝐢𝐧𝐝 𝐚𝐧 𝐞𝐦𝐞𝐫𝐠𝐢𝐧𝐠 𝐬𝐢𝐠𝐧𝐚𝐥.

As trial data evolves, IDMCs need to look beyond standard outputs to understand what may be driving a signal and focus on the evidence that matters most.

Our latest resource explores how experienced support—combining statistical expertise, data management, and effective reporting—can help turn complex interim data into clear, reliable information for independent review.

📊 𝐅𝐫𝐨𝐦 𝐂𝐨𝐦𝐩𝐥𝐞𝐱 𝐃𝐚𝐭𝐚 𝐭𝐨 𝐂𝐥𝐞𝐚𝐫𝐞𝐫 𝐈𝐧𝐬𝐢𝐠𝐡𝐭: 𝐒𝐃𝐀𝐂 𝐀𝐩𝐩𝐫𝐨𝐚𝐜𝐡𝐞𝐬 𝐭𝐨 𝐒𝐭𝐫𝐞𝐧𝐠𝐭𝐡𝐞𝐧 𝐈𝐧𝐝𝐞𝐩𝐞𝐧𝐝𝐞𝐧𝐭 𝐃𝐚𝐭𝐚 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠

👉 Get your copy here: https://go.iddi.com/how-an-experienced-sdac-strengthens-idmc

27/08/2026

“𝘈𝘯𝘺 𝘤𝘰𝘯𝘤𝘭𝘶𝘴𝘪𝘰𝘯 𝘤𝘢𝘯 𝘰𝘯𝘭𝘺 𝘣𝘦 𝘢𝘴 𝘷𝘢𝘭𝘪𝘥 𝘢𝘴 𝘵𝘩𝘦 𝘲𝘶𝘢𝘭𝘪𝘵𝘺 𝘰𝘧 𝘺𝘰𝘶𝘳 𝘥𝘢𝘵𝘢.”

Adaptive trials can make clinical research more efficient and responsive—but their growing complexity requires both sound statistical planning and technology capable of implementing the design accurately. In the first episode of the podcast series "𝐖𝐡𝐞𝐧 𝐌𝐞𝐭𝐡𝐨𝐝𝐨𝐥𝐨𝐠𝐲 𝐌𝐞𝐞𝐭𝐬 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲", Leandro Garcia Barrado, IDDI and Anita Popp, Marvin, eClinical Solution explore how adaptive designs, flexible randomization and the right technology can work together—from protocol to practice.

Watch the first episode here: https://iddi.com/resources/when-methodology-meets-technology-episode-1-from-protocol-to-platform/?utm_source=organic_social&utm_medium=linkedin&utm_campaign=iddi_webinar&utm_content=podcast1 and continue the conversation at our upcoming webinar Project Optimus Meets EDC on 15 October.

Save your spot at: https://go.iddi.com/l/1100512/2026-08-27/3685gv

𝐖𝐡𝐚𝐭 𝐝𝐨𝐞𝐬 𝐚 𝐛𝐞𝐭𝐭𝐞𝐫 𝐭𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐚𝐜𝐭𝐮𝐚𝐥𝐥𝐲 𝐦𝐞𝐚𝐧 𝐟𝐨𝐫 𝐚 𝐩𝐚𝐭𝐢𝐞𝐧𝐭? More time? Fewer severe side effects? Better symptom control? ...
25/08/2026

𝐖𝐡𝐚𝐭 𝐝𝐨𝐞𝐬 𝐚 𝐛𝐞𝐭𝐭𝐞𝐫 𝐭𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐚𝐜𝐭𝐮𝐚𝐥𝐥𝐲 𝐦𝐞𝐚𝐧 𝐟𝐨𝐫 𝐚 𝐩𝐚𝐭𝐢𝐞𝐧𝐭? More time? Fewer severe side effects? Better symptom control? A better quality of life?

At , we develop innovative statistical approaches to help sponsors design more efficient around what truly matters to patients.

Together with our sister company One2Treat, we apply Generalized Pairwise Comparisons ( ) and Net Treatment Benefit ( ) to bring multiple patient-relevant outcomes together, prioritizing them according to what matters most to patients and other stakeholders.

IDDI’s expertise and One2Treat’s technology help sponsors build a more complete picture of treatment benefit, supporting better clinical development decisions and potentially improving the efficiency of clinical trials.

Because better evidence starts with measuring the outcomes that really matter.

Explore a more patient-centric approach to evaluating treatment benefit: https://iddi.com/eclinical-technologies/one-2-treat/

Not every client testimonial mentions expertise. Some mention something much harder to earn: 𝐭𝐫𝐮𝐬𝐭.Recently, a Senior Cl...
20/08/2026

Not every client testimonial mentions expertise. Some mention something much harder to earn: 𝐭𝐫𝐮𝐬𝐭.

Recently, a Senior Clinical Project Manager at a biotech company shared this with our team: "It was really nice working with you and your colleagues. You are smart, quick, honest, and deliver what you promised."

That last part is the one we keep coming back to.

In an industry where timelines shift, challenges emerge, and complexity is part of the journey, delivering on commitments is one of the clearest ways to build trust. Successful partnerships go beyond scientific expertise—they are built through responsiveness, transparency, and a shared commitment to moving programs forward. We’re grateful for the trust our clients place in our teams every day.

Expertise matters. Delivery builds trust. Let's talk: https://iddi.com/

🚨 Webinar alert!𝐃𝐨𝐬𝐞-𝐟𝐢𝐧𝐝𝐢𝐧𝐠 𝐡𝐚𝐬 𝐞𝐯𝐨𝐥𝐯𝐞𝐝. 𝐖𝐡𝐲 𝐚𝐫𝐞 𝐭𝐫𝐢𝐚𝐥 𝐭𝐞𝐚𝐦𝐬 𝐬𝐭𝐢𝐥𝐥 𝐫𝐞𝐥𝐲𝐢𝐧𝐠 𝐨𝐧 𝐬𝐩𝐫𝐞𝐚𝐝𝐬𝐡𝐞𝐞𝐭𝐬? FDA’s Project Optimus is sh...
18/08/2026

🚨 Webinar alert!

𝐃𝐨𝐬𝐞-𝐟𝐢𝐧𝐝𝐢𝐧𝐠 𝐡𝐚𝐬 𝐞𝐯𝐨𝐥𝐯𝐞𝐝. 𝐖𝐡𝐲 𝐚𝐫𝐞 𝐭𝐫𝐢𝐚𝐥 𝐭𝐞𝐚𝐦𝐬 𝐬𝐭𝐢𝐥𝐥 𝐫𝐞𝐥𝐲𝐢𝐧𝐠 𝐨𝐧 𝐬𝐩𝐫𝐞𝐚𝐝𝐬𝐡𝐞𝐞𝐭𝐬? FDA’s Project Optimus is shifting oncology dose selection beyond the Maximum Tolerated Dose toward the Optimal Biological Dose. Yet critical decisions still often depend on delayed data exports and disconnected systems.

In this upcoming webinar, IDDI's Leandro Garcia Barrado will explore modern statistical approaches to dose optimization, while our guest speaker Manuel Neukum, CEO of AB Cube Germany will demonstrate how eClinical technology like Marvin, eClinical Solution can help operationalize adaptive oncology trials.

🎙️Project Optimus Meets EDC: Operationalizing Optimal Dose Trials from Design to Data
📅 15 October 2026 | 4pm CET / 10am EST

Register today to see how methodology and technology come together and turn complex trial designs into clinical practice: https://attendee.gotowebinar.com/register/6655906190722301271

13/08/2026

Clinical data management is more than collecting and cleaning data. It’s about building confidence in every decision that follows.

From study setup and eCRF implementation to data cleaning, coding, reporting, and database lock, provides end-to-end clinical data management support designed to deliver high-quality, submission-ready data.

Our teams combine:
🔹 Scientific expertise to understand the data and the study context
🔹 Methodological excellence to support robust, regulatory-compliant data management
🔹 Operational efficiency to keep studies moving forward
🔹 eClinical expertise across , , reporting, and medical coding

Whether you need dedicated support or an integrated solution, we help you simplify study conduct, strengthen data quality, and accelerate your path to database lock.

Ready to improve the speed and quality of your clinical trials? Talk to our clinical data management experts: https://iddi.com/services/clinical-data-management/

📍 Meet IDDI at SCDM 2026!We’re excited to be exhibiting at   in Raleigh, North Carolina, and connecting with the clinica...
11/08/2026

📍 Meet IDDI at SCDM 2026!

We’re excited to be exhibiting at in Raleigh, North Carolina, and connecting with the clinical data management community from around the world.

This year’s Festival of Opportunity highlights the power of connection — bringing patients, sites, and industry together through data to shape a more connected, patient-centred future for clinical research.

At , we believe that turning clinical data into meaningful insights takes more than data management alone. Our teams bring together expertise in clinical data management, biostatistics, clinical trial design, and data science to help sponsors navigate complexity and make better-informed decisions throughout clinical development.

🤝 Meet our experts Tara Kervin and Maria Khoury at Booth #506 to connect, exchange ideas, explore new opportunities, and discuss how IDDI can support your clinical development programs: https://iddi.com/about-us/events/iddi-exhibiting-at-scdm-annual-conference-2026/

📅 14–17 September 2026
📍 Booth #506

We look forward to seeing you there!

𝐂𝐚𝐧 𝐏𝐊 𝐍𝐂𝐀 𝐛𝐞 𝐦𝐨𝐫𝐞 𝐟𝐥𝐞𝐱𝐢𝐛𝐥𝐞, 𝐞𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐭, 𝐚𝐧𝐝 𝐜𝐨𝐬𝐭-𝐞𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞?In their latest poster, IDDI’s Jennifer Menda and Haley Evans...
07/08/2026

𝐂𝐚𝐧 𝐏𝐊 𝐍𝐂𝐀 𝐛𝐞 𝐦𝐨𝐫𝐞 𝐟𝐥𝐞𝐱𝐢𝐛𝐥𝐞, 𝐞𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐭, 𝐚𝐧𝐝 𝐜𝐨𝐬𝐭-𝐞𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞?

In their latest poster, IDDI’s Jennifer Menda and Haley Evans explore how R can support pharmacokinetic noncompartmental analysis ( ) through a unified workflow for analysis, QC, and visualization.

Using the pkNCA package alongside custom R code, the team demonstrates an approach that can reduce software transitions, support reproducibility, and enable greater flexibility in PK analysis.

Discover the full poster and IDDI’s approach to innovative PK analysis: https://iddi.com/resources/pharmacokinetic-noncompartmental-analysis-pk-nca-using-r-an-efficient-cost-effective-alternative-to-industry-standard-software/

04/08/2026

𝐈𝐂𝐇 𝐄6(𝐑3) 𝐢𝐬 𝐫𝐚𝐢𝐬𝐢𝐧𝐠 𝐭𝐡𝐞 𝐛𝐚𝐫 𝐟𝐨𝐫 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐭𝐫𝐢𝐚𝐥 𝐨𝐯𝐞𝐫𝐬𝐢𝐠𝐡𝐭.

The latest evolution of Good Clinical Practice ( ) places greater emphasis on sponsor oversight, data integrity, and risk-based quality management — reinforcing the need for partners who bring more than operational support.

As clinical trials become increasingly complex, sponsors need teams that can understand their studies deeply, anticipate challenges, and provide scientific guidance to support better decisions.

At , we don’t just support trials — we become an extension of the teams driving them forward. By combining clinical trial expertise, regulatory knowledge, and a collaborative approach, we help sponsors navigate complexity, mitigate risks, and deliver high-quality research.

Because the future of clinical research depends on partnerships built on expertise, trust, and shared commitment. Let’s advance better trials together: https://iddi.com/

𝐇𝐨𝐰 𝐝𝐨 𝐲𝐨𝐮 𝐬𝐞𝐩𝐚𝐫𝐚𝐭𝐞 𝐭𝐫𝐮𝐞 𝐬𝐚𝐟𝐞𝐭𝐲 𝐬𝐢𝐠𝐧𝐚𝐥𝐬 𝐟𝐫𝐨𝐦 𝐛𝐚𝐜𝐤𝐠𝐫𝐨𝐮𝐧𝐝 𝐧𝐨𝐢𝐬𝐞? That's one of the biggest challenges facing Independent D...
28/07/2026

𝐇𝐨𝐰 𝐝𝐨 𝐲𝐨𝐮 𝐬𝐞𝐩𝐚𝐫𝐚𝐭𝐞 𝐭𝐫𝐮𝐞 𝐬𝐚𝐟𝐞𝐭𝐲 𝐬𝐢𝐠𝐧𝐚𝐥𝐬 𝐟𝐫𝐨𝐦 𝐛𝐚𝐜𝐤𝐠𝐫𝐨𝐮𝐧𝐝 𝐧𝐨𝐢𝐬𝐞? That's one of the biggest challenges facing Independent Data Monitoring Committees ( ).

At the Annual Conference 2026, our experts Nicolas Dubois and Céline Mauquoi presented a scientific poster demonstrating how statistical analyses, external evidence, and clinical expertise can be integrated to provide more confident, patient-focused safety evaluations.

"𝘍𝘳𝘰𝘮 𝘚𝘪𝘨𝘯𝘢𝘭𝘴 𝘵𝘰 𝘐𝘯𝘴𝘪𝘨𝘩𝘵: 𝘐𝘯𝘵𝘦𝘨𝘳𝘢𝘵𝘦𝘥 𝘈𝘱𝘱𝘳𝘰𝘢𝘤𝘩𝘦𝘴 𝘧𝘰𝘳 𝘐𝘮𝘱𝘳𝘰𝘷𝘦𝘥 𝘐𝘋𝘔𝘊 𝘚𝘢𝘧𝘦𝘵𝘺 𝘌𝘷𝘢𝘭𝘶𝘢𝘵𝘪𝘰𝘯" highlights 's collaborative approach to helping sponsors make better-informed safety decisions throughout clinical development.

📄 Read the poster to discover how an integrated evidence framework can strengthen IDMC safety assessments: https://iddi.com/resources/from-signals-to-insight-integrated-approaches-for-improved-idmc-safety-evaluation/

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