The IDDI team is excited to present our latest scientific poster about the new FDA guidance on DMCs (Data Monitoring…
IDDI team is excited to present our scientific poster titled “Randomization Tests in R” at the annual PSI Conference 2024….
In Episode 6 of the IDDI Podcast Series, our experts discuss the corresponding pathways in Europe (EMA’s conditional approval pathway)…
Episode 5 of the IDDI Podcast Series: Accelerated Approvals shed light on the role of AA in non-oncology trials with…
Tune in to Episode 4 of IDDI Podcast Series Accelerated Approvals to explore the significant role of Endpoints in securing…
The third episode of the IDDI Podcast Series: Accelerated Approvals delves deeper into the fact that FDA has explicitly stated…
Listen to the second episode of our Podcast Series as our experts dive deep into one vs two trials approaches…
Listen to the first episode of the IDDI’s Podcast series on Accelerated Approvals and learn on the latest FDA draft…
Download the latest IDDI’s poster to learn more about ID-Imagine the all-in-one solution for seamlessly managing project workflows with ease…
Everardo D. Saad, MD, Medical Director and Consultant, IDDI Marc Buyse, ScD, Chief Scientific Officer and Consultant, IDDI The development…
Listen to IDDI’s latest podcast to discover how our regulatory support can help optimize your clinical development strategy. Approval-optimization strategies and…
Join our experts for an insightful webinar to examine the statistical implications of expansive, uncontrolled early-phase trials and discuss the…
Explore the most recent publication by IDDI experts in the journal Cancers (Basel) to learn about a methodological toolkit for…
JACC Review Topic of the Week We are proud to share the most recent JACC “Review Topic of the Week” featured by the Journal of…
Tutorial in Biostatistics – Statistics in Medicine IDDI has written a tutorial on Minimization in randomized clinical trials published in…
Listen to the latest IDDI podcast on Generalized Pairwise Comparisons to learn how this statistical method helped reduce sample sizes…
Subgroup Analysis in Early Drug Development
Join IDDI webinar to learn how the GPC method can be used to design clinical trials with multiple endpoints. You…
Ensuring clinical data is ready for regulatory submission This eBook is a must-read that will enable clinical professionals to better…
Abstract: Purpose Pathologic complete response (pCR) has prognostic importance and is frequently used as a primary end point, but doubts…
Join IDDI webinar to learn more about the ShareView Project which investigated communication approaches and shared decision-making practices across Europe…
Strategic partnership to pair long-standing clinical research expertise with a best-in-class RTSM system
Discover how IDDI biostatistics-driven RTSM helped the Sponsor to avoid serious imbalance between the two randomized arms for the treated…
Discover how a Sponsor reached the overall balance amongst 2 arms by adding a stratification factor.
Discover how a Sponsor optimized the drug delivery via IDDI’s Proposition of a Predictive Drug Supply Model. PLEASE FILL IN…
Join IDDI and Mentor RTSM‘s experts to learn how combined advanced biostatistics and innovative integrated randomization and trial supply management…
Randomized controlled trials (RCTs), particularly in phase 3, are the preferred sources of evidence for drug approval and reimbursement decisions….
Learn on statistical explanations for a large proportion of Phase III clinical trials failures, and how to address both the…
AN INNOVATIVE STATISTICAL METHOD PAVING THE WAY TO PERSONALIZED MEDICINE The method of Generalized Pairwise Comparisons (GPC) fulfills a recent literature trend…
Join August Research and IDDI’s experts in the 60-minute complimentary webinar to gain insights into trial design and execution strategies…
September 22, 2022 | 5:00-6:00 PM CEST | 11:00 AM – 12:00 PM EDT ABSTRACT The increasing cost of new…
Generalized Pairwise Comparisons – GPC Today’s session is focusing on an innovative statistical methodology called Generalized Pairwise Comparisons – or…
Learn on the features, advantages and disadvantages of adaptive designs and group-sequential designs and their regulatory aspects of Phase II/III trials…
This webinar presented the results of a new study that further demonstrated that risk-based monitoring is an efficient tool to…
Phase I/II study in cancer patients showcases eClinical effectiveness. An Article written by IDDI Published in Applied Clinical Trials, February…
In collaboration with MVA, IDDI team is pleased to invite you to a Good Morning Meeting COPENHAGEN, DENMARK | APRIL…
Join IDDI experts to get updated on efficacy assessment in early-phase trials and more! ABSTRACT: One of the major recent…
Be updated on different types of Bayesian and frequentist designs that may be used for expansion cohorts in phase 1…
2021 marks IDDI’s 30 year anniversary We are truly grateful to the 350+ pharmaceutical and biotech companies, as well as…
This webinar was presented by Laurence Collette, MSc, PhD, Principal Statistician, Consulting Services at IDDI at the 5th Annual Next…
Demystifying different types of Bayesian and frequentist designs that may be used for first-in-human or other types of phase I…
Using the promising-zone approach can salvage an underpowered trial. Sample size Re-estimation (SSRE) is a relatively new concept, but, thanks…
Vaiva Deltuvaite-Thomas, Research Statistician, IDDI and Prof. Tomasz Burzykowski, VP Research IDDI have just published an article on operational characteristics…
With some of the recently developed drugs showing unprecedented response rates and consistent improvement in overall survival in some indications,…
Learn on the central role of Biostatistics in the COVID-19 Pandemia, and the multidisciplinary nature of pandemic response LISTEN TO…
WATCH RECORDED WEBINAR Drug development in oncology is undergoing several changes brought about by precision medicine, which makes it appealing…
Cancer research is complex: trials require specific design expertise and often include biomarker and companion diagnostics, and failure rates tend…
Nowadays, drug development in oncology is largely centered on the basic premise of precision medicine, according to which targeted agents…
Read article on trial design and sample sizes for early trials Written by Elisabeth Coart and Everardo D. Saad, Consulting…
Today’s session is focusing on some of the key advantages our clients have realized working with our clinical data management…
In addition to pharmaceutical and biopharmaceutical sponsors outsourcing clinical trials to Contract Research Organizations (CROs) to gain flexibility and speed…
Learn on pragmatic randomized clinical trials and real-world evidence KEY TAKEWAYS Patient access to evidence-based innovations can be accelerated if…
Webinar on the Benefits of an Electronic Data Capture EDC designed by Investigators for Investigators WATCH RECORDED WEBINAR Gather deeper…
Dr. Everardo Saad, Medical Director of IDDI contributed to an article on Personalized Medicine published in the June issue of…
Estimands Framework: Ensuring alignment between the key scientific question of interest, analysis and interpretation during clinical trial design. The estimands…
The Only Biostatistics-driven RTSM IDDI uses Mentor RTSM (powered by Sitero) system because the solution allows faster deployment of your studies….
Focusing on the accuracy of your clinical data, our data management experts are committed to delivering timely, accurate and high…
At IDDI, statistical methodology is at the heart of every clinical study, driving study design, protocol development, clinical data collection,…
Clinical Data Quality First! Your Trusted Partner Delivering Biostatistical and Clinical Data Science services since 1991 METHODOLOGICAL EXCELLENCE +…
IDDI selected by a Sponsor as the full biometric partner including eClinical tools (EDC & RTSM), data collection, data cleaning…
IDDI Webinar on the SOCRATES (Standard of Care Randomized Trials) MODEL LEARN ON THE CHALLENGES AND OPPORTUNITIES OF THE STANDARD…
LEARN ON SAMPLE-SIZE RE-ESTIMATION, CONDITIONAL POWER AND THE PROMISING-ZONE METHOD. In this webinar, we will play the part of a sponsor consulting…
IDDI contributed to the Pharmavoice article: Commanders & Chiefs: Clinical Services C-Suite, February, 2021 CROs and other clinical services companies…
Learn on history of bias and randomization in oncology clinical trials and how to think about what constitutes persuasive evidence…
IDDI and XClinical webinar on the importance and the benefits Clinical Systems Integration WHAT YOU WILL LEARN:
Improvements in the treatment of patients with cancer largely depend on clinical trials comparing a new intervention with a previous…
IDDI Complimentary Webinar on characteristics of Covid-19 trials and impact of the pandemic on clinical trials The current SARS-CoV-2-induced…
The purpose of the REALI pooled analysis is to advance the understanding of the effectiveness and real world safety of insulin Gla-300 based on a large European patient database of post-marketing interventional and observational studies.
IDDI Complimentary Webinar on the need for integration of biomarker and IVD validation in clinical development Drug development in many…
IDDI Complimentary Webinar on Immuno-Oncology Immuno-oncology is a buoyant field of research, with recently developed drugs showing unprecedented response rates…
Adaptations to tumor response and progression criteria for immune therapies. Abstract Immuno-oncology is a buoyant field of research, with recently…
What should companies look for when selecting a CRO clinicalpartner? Just one in ten drug candidates are successful in clinical…
The development and qualification of biomarkers are keys to the future of drug development and precision medicine, particularly in oncology….
Today’s session is focusing on: the correct implementation of RTSM solutions is key to ensuring operational success of the clinical…
Successfully Delivering of Harmonized SAS SDTM Database PLEASE FILL IN THE FORM TO ACCESS THE CASE STUDY
The COVID-19 pandemic has a major impact on the conduct of most on-going clinical trials, in particular on the treatment…
Today’s session is focusing on the key role that project management plays when delivering all services at IDDI, and how…
IMPACT OF COVID-19 on Clinical Trials: LEARN ON OPERATIONAL CHALLENGES TO CONSIDER, ESPECIALLY RELATED TO MISSING DATA AND PROTOCOL DEVIATIONS …
Insight on the pharma and biopharma trends impacting CROs, Outsourcing in today’s market, and advances in clinical research. READ IDDI…
Today’s session is focusing on the key clinical trial services of data management & biostatistics, and considerations for why there…
Listen to IDDI Podcast on IDDI Services Vicky Martin, Sr Business Director US , IDDI Learn more on IDDI…
IDDI Complimentary Webinar on Minimization LEARN ON: Minimization method including demonstration of some of the advantages of minimization over permuted…
IDDI and Montrium joint live webinar on the relationship between eTMF and CDM and the benefits of having an integrated approach …
Transforming statistical data into a surrogate endpoint can enable comprehension of trial results sooner than usual, but few make the…
IDDI in collaboration with Roche have identified why using disease-free survival as a primary endpoint in early breast cancer is…
IDDI Free Live Webinar: Bayesian Outcome-Adaptive Randomization Designs: a promise not without peril Learn on the crucial elements of implementing OAR…
IDDI: coup de pouce à la médecine personnalisée L’entreprise de Louvain-la-Neuve développe une méthode statistique innovante, qui pourrait bousculer les…
IDDI in Contract Pharma Magazine IDDI, BMS Consortium aims to establish that the GPC statistical method can complement the design,…
Free Webinar on Expansion Cohorts in Early Development of Anticancer Agents In this webinar we reviewed: The recent literature related…
The need to consider randomization whenever feasible in expansion cohorts The purpose of IDDI comments on FDA Draft guidance is to…
Free Live Webinar: Assessing Treatment Benefit in Immuno-Oncology In this webinar we reviewed key issues related to endpoints in immuno-oncology,…
Free Webinar on Biostatistical Challenges of Trials in Rare Diseases VIEW RECORDED WEBINAR CONTENTS: In this webinar: We will start by…
A New Statistical Method: Generalized Pairwise Comparisons to Assess Treatment Benefit/Risk IN THIS WEBINAR OUR SPEAKERS DESCRIBED A NEW STATISTICAL METHOD,…
IDDI, dont l’expertise dans la gestion et l’analyse des données cliniques des patients est mondialement reconnue, fait évoluer son actionnariat…
In this free webinar on Treatment Allocation in Randomized Trials, the speakers discussed: the rationale for the various randomization methods,…
Since the early days of clinical cancer research, given the expected direct cytotoxicity of chemotherapy, tumor shrinkage has been used…
Clinical Trial Solutions: Biostatistics and integrated eClinical Services for Phase I-IV Clinical Trials IDDI provides full range of clinical trial…
Enabling Integrated eClinical solutions Single Front-End for EDC – RTSM – Drug Supply Management and Medical Coding IDDI’s eClinical solutions and…
Oncology CRO Providing Full Range of Biostatistics and eClinical Solutions IDDI is an oncology CRO led by a highly-skilled biostatistical…
Clinical Research Consultants Our Clinical Research Consultants provide Clinical, Statistical and Regulatory Expert Services to accelerate the development of your drug, biomarker…
IDDI in the Media BIOWIN Newsletter Deux projets de R&D dans les starting-blocks (July 2017): “TREATBEST, est un consortium composé…
IDDI organized a webinar on the current use and potential of Health Technology Assessment (HTA) as a component of clinical trials…
IDDI organized a webinar on the Current Status of Surrogates for Survival in Cancer Trials. VIEW THE RECORDING OF THE…
IDDI organized a webinar on Personalized Cancer Medicine Needs Randomized Trials. Clinical cancer research is undergoing profound changes, mostly because…
IDDI organized a webinar on Patient-Level Data Sharing in Clinical Research. Our experts from IDDI and GSK spoke about principles, opportunities,…
IDDI organized a webinar on the analytical validation of in-vitro diagnostic devices entitled ‘From Biomarkers to In-vitro Companion Diagnostic Device :…
IDDI organized a webinar on the Future of Cancer Clinical Trials. Cancer clinical trials have been a major determinant of…
IDDI organized a webinar on Data Monitoring Committees (DMC) best practices. This webinar explored data monitoring committees (DMC) best practices…
IDDI organized a webinar on Implementing Adaptive Trials: Operational Considerations. WATCH RECORDED WEBINAR TO ACCESS THE PRESENTATION OF THIS ON-DEMAND WEBINAR,…
IDDI organized a webinar on Pros and Cons of Adaptive Designs. Topics included: Continual reassessment methods for phase I trials Adaptive…
IDDI organized a webinar on Efficient Designs in Phase I oncology trials. The key learning objectives of this webinar were…
Efficient CRO Collaboration IDDI organized a webinar on FRUITFUL SPONSOR/CRO COLLABORATION: HOW TO SUCCEED. The goal of this talk is…
IDDI organized a webinar on THE NEED FOR BETTER CLINICAL ENDPOINTS : TOWARDS A MORE EFFICIENT DRUG DEVELOPMENT IN ONCOLOGY The…
IDDI organized a webinar on Statistical Approach to Central Monitoring of Clinical Trials This webinar presented the underlying principles of a…
IDDI organized a webinar on DESIGNS OF NON-INFERIORITY and BIOSIMILAR CLINICAL TRIALS. This webinar presented key concepts and current examples regarding…
Clinical Data Collection IDDI organized a webinar on Achieving Efficiency in Clinical Data Collection. The speaker described the options to consider…
Comprehensive CDISC SDTM-ADaM Data Conversion Services. As certified CDISC Registered Solutions Provider we have the professional expertise to provide comprehensive CDISC SDTM/ADaM…
Clinical Data Management Solutions: Quality Data Ready for Submission Clinical Data Management solutions for clinical research support all aspects of your study…
Ophthalmology CRO IDDI is a leading global ophthalmology CRO offering biostatistics and eClinical solutions for ophthalmology studies. We have run nearly 100 trials in…
Randomization Services IDDI Randomization and Trial Supply Management (RTSM) in-house System
Medical Coding Services ID-code: Medical Coding System fully integrated into our EDC system. We provide medical coding services via ID-code….
IDDI Accelerates Your Statistical Biomarker-IVD Validation IDDI has experience in the identification and statistical biomarker -IVD validation of diagnostic utility, prognostic and/or…
Key Risk Indicators (KRIs): A flexible approach to adaptive monitoring in multi-center clinical trials. IDDI delivers statistical quality control of…
We have experience in the challenging statistical issues that characterize the identification and validation of biomarkers for personalized medicine that have diagnostic utility,…
Full integration between EDC and IRT system In a double-blind randomized placebo-controlled Phase II study, IDDI set up a complete integration…
Our client in this case was an investment organization specialized in biotechnology companies, and they required an urgent analysis of…
Assessment of Clinical Validity of Circulating Tumor Cells (CTC) Quantification Clinical Validity Of Circulating Tumor Cells (CTC) In Patients With…
Phase II study conducted with a dose-escalation minimization A phase II ophthalmology study was conducted with a dose-escalation minimization to…
Biostatistical Expertise For Developing New Biomarkers And Diagnostic Tests IDDI has a long-term collaboration with a Sponsor to provide biostatistical…
A Bayesian Study Design For Seamless Transition Between Phase II And Phase III Data collected by a sponsor suggested a…
A Flexible Study Design with Randomization to Placebo The maximum tolerated dose of a new drug, supposed to alleviate some…
New prognostic biomarkers for breast cancer: A range of biological markers were analyzed by polymerase chain reaction and immunohistochemistry in…
In this meta-analysis, tumor responses and survival were analyzed combining the data from the different trials using patient individual data. The…
Data Safety Monitoring Formal data safety monitoring, often performed by independent committees of physicians, biostatisticians and ethicists, has become common…
A 70-genetic signature was shown in a single institution to have prognostic value in patients with node-negative breast cancer. The…
Adverse Events coded by IDDI Medical Coding System Two pivotal trials were conducted (one in the US, one in Europe)…
A new ophthalmic drug was going to enter a phase II dose-ranging trial in order to determine the dose to…
Biomarker Analysis with the Mixed Modelling Methodology Two doses of a therapeutic vaccine were tested simultaneously in a randomized phase II…
Meta-Analysis performed with IDDI’s Methodology Skills IDDI has been involved in numerous meta-analyses to directly or indirectly support new drug applications….
Surrogate endpoint for overall survival We managed to prove, using data from a randomized trial comparing Ceplene + IL-2 to…
Free Webinar on Biomarker-Based Clinical Trial Designs The webinar on biomarker-based clinical trial designs reviewed of the recently proposed-designs, including adaptive…
IDDI organized its first free live webinar on STATISTICAL VALIDATION OF BIOMARKERS WATCH RECORDED WEBINAR TO ACCESS THE PRESENTATION OF THIS…
IDDI organized its second free live webinar on DEVELOPMENT AND VALIDATION OF CLINICALLY USEFUL GENE SIGNATURES. This webinar reviewed statistical issues…
IDDI organized a webinar on Operational Aspects of Data Monitoring Committees. The webinar explored best practices that have emerged during this…
A multi-center phase II trial was conducted in just over 100 patients to compare metabolic changes in the prostate after…
IDDI organized a webinar on DESIGN AND ANALYSIS OF PHASE II TRIALS IN ONCOLOGY. This webinar presented key concepts and…
IDDI announces the appointment of Dr. Everardo Saad as Senior Medical Expert as of July 2014. Everardo brings over 12 years…
IDDI, an international functional Contract Research Organisation (CRO) headquartered in Belgium, replaced its mix of a paper-based trial master file…
A new Software for Risk-based Monitoring As biopharmaceutical sponsors search for the optimal approach to targeted monitoring and reduced Source…
Central Statistical Monitoring of Data Quality in Clinical Trials IDDI announces publication on Central Statistical Monitoring: ‘A statistical approach to central…
Integrated EDC IWRS system: The IWR/IVR system ID-netTM developed by IDDI now provides an interface to MARVIN, XClinical’s EDC system. …
IDDI, announces that it has signed a collaborative agreement with I-BioStat, the Interuniversity Institute for Biostatistics and statistical Bioinformatics, which…
Successful Partnership with Tigenix for Approval of Chondrocelect for Cartilage Repair IDDI’s contributed statistical methodology towards approval of ChondroCelect® TiGenix’s…
