IDDI The Highest Standard in Clinical Data Science IDDI โ€˜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 web 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.

โ€ข 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

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

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

โ‡’Leads to Successful Regulatory Submission

๐€ ๐ฌ๐ฎ๐ซ๐ซ๐จ๐ ๐š๐ญ๐ž ๐ž๐ง๐๐ฉ๐จ๐ข๐ง๐ญ ๐œ๐š๐ง ๐š๐œ๐œ๐ž๐ฅ๐ž๐ซ๐š๐ญ๐ž ๐ฒ๐จ๐ฎ๐ซ ๐œ๐ฅ๐ข๐ง๐ข๐œ๐š๐ฅ ๐ฌ๐ญ๐ซ๐š๐ญ๐ž๐ ๐ฒ. ๐๐ฎ๐ญ ๐ก๐จ๐ฐ?In  , surrogates have been used to expedite approval...
15/10/2026

๐€ ๐ฌ๐ฎ๐ซ๐ซ๐จ๐ ๐š๐ญ๐ž ๐ž๐ง๐๐ฉ๐จ๐ข๐ง๐ญ ๐œ๐š๐ง ๐š๐œ๐œ๐ž๐ฅ๐ž๐ซ๐š๐ญ๐ž ๐ฒ๐จ๐ฎ๐ซ ๐œ๐ฅ๐ข๐ง๐ข๐œ๐š๐ฅ ๐ฌ๐ญ๐ซ๐š๐ญ๐ž๐ ๐ฒ. ๐๐ฎ๐ญ ๐ก๐จ๐ฐ?

In , surrogates have been used to expedite approvals by replacing overall survival, thereby shortening the development program by 1 to 2 years. This is best done when a surrogate can be properly validated at both the patient and trial level.

More recently, a new avenue has been opened by the regulatory acceptance of partially validated surrogates when patient benefit is expected from a treatment that impacts a patient-level surrogate, such as minimal residual disease and circulating tumor DNA, increasing the chance of accelerated approval based on these novel endpoints.

For decades, 's experts have helped shape the science of surrogate endpoints validation, playing a pivotal role in establishing the meta-analytical framework that has informed approaches used by regulatory and health technology assessment bodies, including the FDA and Germany's IQWiG.

With nearly 100 peer-reviewed publications and pioneering methodological expertise, our strategic consulting team helps sponsors navigate complex endpoint strategies, from clinical study design through regulatory submission and interactions with health authorities.

Discover IDDI's Strategic Consulting expertise: https://iddi.com/services/strategic-consulting/

โณ 2 ๐๐š๐ฒ๐ฌ ๐ญ๐จ ๐ ๐จ! ๐€๐ซ๐ž ๐ฒ๐จ๐ฎ ๐ซ๐ž๐š๐๐ฒ ๐ญ๐จ ๐ญ๐ฎ๐ซ๐ง ๐š๐๐š๐ฉ๐ญ๐ข๐ฏ๐ž ๐ญ๐ซ๐ข๐š๐ฅ ๐๐ž๐œ๐ข๐ฌ๐ข๐จ๐ง๐ฌ ๐ข๐ง๐ญ๐จ ๐š๐œ๐ญ๐ข๐จ๐ง?An adaptive trial design is only as effective...
13/10/2026

โณ 2 ๐๐š๐ฒ๐ฌ ๐ญ๐จ ๐ ๐จ! ๐€๐ซ๐ž ๐ฒ๐จ๐ฎ ๐ซ๐ž๐š๐๐ฒ ๐ญ๐จ ๐ญ๐ฎ๐ซ๐ง ๐š๐๐š๐ฉ๐ญ๐ข๐ฏ๐ž ๐ญ๐ซ๐ข๐š๐ฅ ๐๐ž๐œ๐ข๐ฌ๐ข๐จ๐ง๐ฌ ๐ข๐ง๐ญ๐จ ๐š๐œ๐ญ๐ข๐จ๐ง?

An adaptive trial design is only as effective as its ex*****on. But when critical decision points arrive, are your data, systems, and trial teams ready to act?

Join experts from and Marvin, eClinical Solution as they explore how to bridge the gap between trial design and operational ex*****on, using oncology dose optimization as a practical case.

๐Ÿ“… October 15 | 4pm CEST / 10am EDT
๐ŸŽฏ Register now: https://register.gotowebinar.com/register/6655906190722301271

In ophthalmology trials, treatment effects may be assessed through letters, images, or measurements down to fractions of...
08/10/2026

In ophthalmology trials, treatment effects may be assessed through letters, images, or measurements down to fractions of a millimeter. Understanding whether those changes represent meaningful evidence is rarely straightforward.

Endpoints may be highly specialized. Measurements can vary between eyes, sites, and assessors. Disease progression may be slow or heterogeneous. And these complexities need to be considered from trial design through analysis and regulatory submission.

On , the global focus is on the importance of eye health. For those working to bring new ophthalmic treatments to patients, it is also a reminder of the rigorous science needed to turn clinical data into reliable evidence.

Drawing on decades of biostatistical and clinical data science experience, IDDI supports development across the clinical trial journey. Explore our perspectives on designing more efficient ophthalmology trials: https://iddi.com/resources/5-data-driven-steps-for-successful-ophthalmology-trials/

๐๐จ๐ญ ๐ž๐ฏ๐ž๐ซ๐ฒ ๐ช๐ฎ๐ž๐ฌ๐ญ๐ข๐จ๐ง ๐š๐ง ๐ˆ๐ƒ๐Œ๐‚ ๐Ÿ๐š๐œ๐ž๐ฌ ๐œ๐š๐ง ๐›๐ž ๐š๐ง๐ญ๐ข๐œ๐ข๐ฉ๐š๐ญ๐ž๐.Is the evidence sufficient to support a decision?Does the committee ...
07/10/2026

๐๐จ๐ญ ๐ž๐ฏ๐ž๐ซ๐ฒ ๐ช๐ฎ๐ž๐ฌ๐ญ๐ข๐จ๐ง ๐š๐ง ๐ˆ๐ƒ๐Œ๐‚ ๐Ÿ๐š๐œ๐ž๐ฌ ๐œ๐š๐ง ๐›๐ž ๐š๐ง๐ญ๐ข๐œ๐ข๐ฉ๐š๐ญ๐ž๐.

Is the evidence sufficient to support a decision?
Does the committee have the data and analyses it needs?
What happens when an unexpected safety signal or trial issue emerges?

Effective oversight starts well before the first committee meeting. It requires thoughtful planning, appropriate statistical support, reliable reporting, and the flexibility to respond as evidence evolves.

๐Œ๐š๐ฌ๐ญ๐ž๐ซ๐ข๐ง๐  ๐ˆ๐ƒ๐Œ๐‚๐ฌ brings together practical considerations for preparing and supporting IDMCsโ€”from planned interim reviews to the unexpected questions that can arise during a trial.

๐Ÿ“˜Explore the eBook โ†’ https://go.iddi.com/ebook-mastering-idmcs

A big shout-out to our   team who came together for RUN TO KICK 2026, whether hitting the course as runners and walkers ...
05/10/2026

A big shout-out to our team who came together for RUN TO KICK 2026, whether hitting the course as runners and walkers or supporting the event as volunteers.

And what a year to be part of it: โ‚ฌ2.5 million raisedโ€”a new RUN TO KICK record! ๐ŸŽ‰

Together with 5,000 runners and walkers, we helped support a cause that matters deeply to us: advancing research to improve the future for children with cancer.

๐Ÿ‘ Congratulations to everyone who participated, volunteered, donated, and supported the . Every step counts. ๐Ÿ’›

Behind every advance in breast cancer care is evidence built patient by patient, data point by data point๐ŸŽ€Breast cancer ...
01/10/2026

Behind every advance in breast cancer care is evidence built patient by patient, data point by data point๐ŸŽ€

Breast cancer remains the most commonly diagnosed among women worldwide. Yet progress in screening, diagnosis, and treatment continues to change what a breast cancer diagnosis can mean.

This , we recognize the patients, families, healthcare professionals, and researchers behind that progressโ€”and the importance of continuing to build reliable evidence that can lead to better treatment decisions.

For more than three decades, has contributed statistical and clinical data science expertise to oncology research, including longstanding academic collaborations in breast cancer.

Because behind the data are patients. And behind better decisions is evidence we can trust.

๐€๐œ๐œ๐ž๐ฅ๐ž๐ซ๐š๐ญ๐ž๐ ๐ญ๐ข๐ฆ๐ž๐ฅ๐ข๐ง๐ž๐ฌ ๐ฉ๐ฎ๐ญ ๐๐š๐ญ๐š ๐ซ๐ž๐š๐๐ข๐ง๐ž๐ฌ๐ฌ ๐ญ๐จ ๐ญ๐ก๐ž ๐ญ๐ž๐ฌ๐ญ.When development moves faster, data still needs to be trustworthy, ...
29/09/2026

๐€๐œ๐œ๐ž๐ฅ๐ž๐ซ๐š๐ญ๐ž๐ ๐ญ๐ข๐ฆ๐ž๐ฅ๐ข๐ง๐ž๐ฌ ๐ฉ๐ฎ๐ญ ๐๐š๐ญ๐š ๐ซ๐ž๐š๐๐ข๐ง๐ž๐ฌ๐ฌ ๐ญ๐จ ๐ญ๐ก๐ž ๐ญ๐ž๐ฌ๐ญ.

When development moves faster, data still needs to be trustworthy, standardized, traceable, and ready to support regulatory review.

In Episode 3 of ๐–๐ก๐ž๐ง ๐Œ๐ž๐ญ๐ก๐จ๐๐จ๐ฅ๐จ๐ ๐ฒ ๐Œ๐ž๐ž๐ญ๐ฌ ๐“๐ž๐œ๐ก๐ง๐จ๐ฅ๐จ๐ ๐ฒ, โ€™s Leandro Garcia Barrado and Nicole Kuisle from Marvin, eClinical Solution explore the connection between accelerated approval pathways, data transparency, and EDCโ€”and why thinking about regulatory readiness early can make a difference later.

โ–ถ๏ธ Watch From Data to Delivery: EDCโ€™s Role in Accelerated Approvals and Trustworthy Evidence: https://iddi.com/resources/when-methodology-meets-technology-episode-3-from-data-to-delivery/?utm_source=IDDI_Marvin+Webinar&utm_medium=organic&utm_campaign=social&utm_content=podcast+3

Want to learn how this translates into the ex*****on of complex adaptive trials? Join us for our upcoming live webinar:
๐ŸŽ™๏ธ ๐๐ซ๐จ๐ฃ๐ž๐œ๐ญ ๐Ž๐ฉ๐ญ๐ข๐ฆ๐ฎ๐ฌ ๐Œ๐ž๐ž๐ญ๐ฌ ๐„๐ƒ๐‚: ๐Ž๐ฉ๐ž๐ซ๐š๐ญ๐ข๐จ๐ง๐š๐ฅ๐ข๐ณ๐ข๐ง๐  ๐Ž๐ฉ๐ญ๐ข๐ฆ๐š๐ฅ ๐ƒ๐จ๐ฌ๐ž ๐“๐ซ๐ข๐š๐ฅ๐ฌ ๐Ÿ๐ซ๐จ๐ฆ ๐ƒ๐ž๐ฌ๐ข๐ ๐ง ๐ญ๐จ ๐ƒ๐š๐ญ๐š
๐Ÿ“… 15 October 2026 | 4 PM CEST / 10 AM EDT
๐Ÿ”— Register today: https://register.gotowebinar.com/register/6655906190722301271?utm_source=organic&utm_medium=social&utm_campaign=iddi_webinar&utm_content=register

๐–๐ก๐š๐ญ ๐ข๐ฌ ๐ฒ๐จ๐ฎ๐ซ ๐ญ๐ซ๐ข๐š๐ฅ ๐ซ๐ž๐š๐ฅ๐ฅ๐ฒ ๐ญ๐ž๐ฅ๐ฅ๐ข๐ง๐  ๐ฒ๐จ๐ฎ? Sometimes, the answer is not obvious from a single safety signal or interim resul...
24/09/2026

๐–๐ก๐š๐ญ ๐ข๐ฌ ๐ฒ๐จ๐ฎ๐ซ ๐ญ๐ซ๐ข๐š๐ฅ ๐ซ๐ž๐š๐ฅ๐ฅ๐ฒ ๐ญ๐ž๐ฅ๐ฅ๐ข๐ง๐  ๐ฒ๐จ๐ฎ?

Sometimes, the answer is not obvious from a single safety signal or interim result. Effective IDMC oversight can bring context to evolving evidence, identify issues that may otherwise be missed, and help determine when the evidence is strong enough to support an important decisionโ€”all while protecting patients and preserving trial integrity.

In this podcast, Marc Buyse, ScD, Founder and Chief Scientific Officer of , draws on decades of experience to share practical lessons on what makes an IDMC effective, where sponsors commonly go wrong, and how IDMC decisions can shape the direction and credibility of a trial.

๐ŸŽ™๏ธโ€œThe IDMC is the safeguard of the trial. It protects against the unexpected and keeps the results credible.โ€

โ–ถ๏ธ Watch the full conversation: https://go.iddi.com/idmc-insights-roles-risks-and-real-world-lessons-li

Scientific collaborations often begin with a shared research question. Exceptional ones continue to generate meaningful ...
22/09/2026

Scientific collaborations often begin with a shared research question. Exceptional ones continue to generate meaningful evidence over many yearsโ€”and, in this case, across cancer types.

IDDIโ€™s longstanding academic collaboration with Institut Jules Bordet has contributed to influential oncology researchโ€”from landmark publications in breast cancer to the latest real-world study of total neoadjuvant therapy (TNT) in re**al cancer.

Led by Professor Francesco Sclafani, the current collaboration brings together nearly 2,000 patients from more than 60 centers across over 20 countries. โ€™s Vaiva Deltuvaite - Thomas and Vincent Staggs provided the statistical analyses and modelling, with the first findings published in JAMA Oncology.

A collaboration grounded in academic rigor, deep oncology knowledge and statistical expertiseโ€”continuing with new analyses and research questions.

Planning your next oncology study? Connect with IDDIโ€™s experts: https://iddi.com/

๐Ÿงก ๐’๐š๐Ÿ๐ž ๐œ๐š๐ซ๐ž ๐Ÿ๐จ๐ซ ๐ฅ๐ข๐Ÿ๐ž.This  , the focus is on safe care for people living with noncommunicable diseasesโ€”including cancer,...
17/09/2026

๐Ÿงก ๐’๐š๐Ÿ๐ž ๐œ๐š๐ซ๐ž ๐Ÿ๐จ๐ซ ๐ฅ๐ข๐Ÿ๐ž.
This , the focus is on safe care for people living with noncommunicable diseasesโ€”including cancer, cardiovascular diseases, diabetes and chronic respiratory diseasesโ€”conditions that often require treatment and follow-up over many years.

Across this continuum of care, patient safety depends on informed decisions, reliable evidence, and listening to the people whose lives are affected by those decisions.

At , weโ€™re proud to contribute to clinical research that builds trustworthy evidence and supports better, safer care for patients.

Adresse

30, Avenue Provinciale
Ottignies-Louvain-la-Neuve
1340

Heures d'ouverture

Lundi 08:30 - 18:00
Mardi 08:30 - 18:00
Mercredi 08:30 - 18:00
Jeudi 08:30 - 18:00
Vendredi 09:00 - 18:00

Tรฉlรฉphone

+3210614444

Notifications

Soyez le premier ร  savoir et laissez-nous vous envoyer un courriel lorsque IDDI publie des nouvelles et des promotions. Votre adresse e-mail ne sera pas utilisรฉe ร  d'autres fins, et vous pouvez vous dรฉsabonner ร  tout moment.

Contacter L'entreprise

Envoyer un message ร  IDDI:

Raccourcis

Partager

Catรฉgorie