Applying Likelihood Method For Data Safety Monitoring
Data Safety Monitoring Formal data safety monitoring, often performed by independent committees of physicians, biostatisticians and ethicists, has become common…
Resources
Resources
Free Resources Library related to clinical trial innovation : Discover our recorded webinars, service flyers, experience, white papers and more related to clinical development.
Validation of a Genetic Signature For Women With Node-Negative Breast Cancer
A 70-genetic signature was shown in a single institution to have prognostic value in patients with node-negative breast cancer. The…
Validating Adverse Events On A Large Scale
Adverse Events coded by IDDI Medical Coding System Two pivotal trials were conducted (one in the US, one in Europe)…
Jumping Ahead to Phase III trial
A new ophthalmic drug was going to enter a phase II dose-ranging trial in order to determine the dose to…
Analyzing a Biomarker As A Proof Of Concept
Biomarker Analysis with the Mixed Modelling Methodology Two doses of a therapeutic vaccine were tested simultaneously in a randomized phase II…
Meta-Analysis of Clinical Trials to Support New Drug Approval
Meta-Analysis performed with IDDI’s Methodology Skills IDDI has been involved in numerous meta-analyses to directly or indirectly support new drug applications….
Anti-cancer drug approved based on a surrogate endpoint
Surrogate endpoint for overall survival We managed to prove, using data from a randomized trial comparing Ceplene + IL-2 to…
Biomarker-Based Clinical Trial Designs
December 9, 2010
Free Webinar on Biomarker-Based Clinical Trial Designs The webinar on biomarker-based clinical trial designs reviewed of the recently proposed-designs, including adaptive…
Statistical Validation of Biomarkers
June 22, 2010
IDDI organized its first free live webinar on STATISTICAL VALIDATION OF BIOMARKERS This webinar reviewed: The use of biomarkers and surrogate…
Development and Validation of Clinically Useful Gene Signatures
September 3, 2010
IDDI organized its second free live webinar on DEVELOPMENT AND VALIDATION OF CLINICALLY USEFUL GENE SIGNATURES. This webinar reviewed statistical issues…