Case Studies

Case Studies

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Overcoming Clinical Trial Design Challenges in a Phase I/II Phase Myelodysplastic syndrome study

Case Studies

Study Description A phase I/II open-label, multi-center, dose-finding, safety, efficacy study on patients with higher risk myleodisplastic syndrome (MDS) and…

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Case study: The REALI pooled analysis of the European post-marketing studies for the TOUJEO® product

Case Studies

The purpose of the REALI pooled analysis is to advance the understanding of the effectiveness and real world safety of…

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Overcoming the challenges of Collaborative Global Trials to deliver Harmonized SAS SDTM Database 

Case Studies

Successful Delivering of Harmonized SAS SDTM Database  STUDY DESCRIPTION A Prospective, Randomized, Double-Blind, Phase III clinical trial in women with…

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A Single Front-End For EDC and Randomization

Case Studies

Full integration between EDC and IRT system In a double-blind randomized placebo-controlled Phase II study, IDDI set up a complete integration…

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Independent Analyses To Inform Go/No-go Decisions

Case Studies

Our client in this case was an investment organization specialized in biotechnology companies, and they required an urgent analysis of…

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Clinical Validity Of Circulating Tumor Cells (CTC)

Case Studies

Assessment of Clinical Validity of Circulating Tumor Cells (CTC) Quantification Clinical Validity Of Circulating Tumor Cells (CTC) In Patients With…

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A Double Masked Minimization in Ophthalmology Study

Case Studies

Phase II study conducted with a dose-escalation minimization A phase II ophthalmology study was conducted with a dose-escalation minimization to…

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Developing New Biomarkers And Diagnostic Tests

Case Studies

Biostatistical Expertise For Developing New Biomarkers And Diagnostic Tests IDDI has a long-term collaboration with a Sponsor to provide biostatistical…

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Bayesian Study Design

Case Studies

A Bayesian Study Design For Seamless Transition Between Phase II And Phase III Data collected by a sponsor suggested a…

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Flexible Study Design

Case Studies

A Flexible Study Design with Randomization to Placebo The maximum tolerated dose of a new drug, supposed to alleviate some…

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