Featured Articles
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Evaluating A CRO For Rare Disease Studies: A Checklist For Success
5/18/2023
When launching an RFP, refer to this checklist to ensure comprehensive coverage of all aspects when evaluating potential research partners for the rare disease study.
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Revolutionary CAR-T Therapies Pave Way To Conquer Solid Tumors
5/1/2023
Get a comprehensive and insightful overview of the latest advancements in CAR-T cell therapy and their potential to transform cancer treatment.
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Rescuing A Phase 1 Oncology Trial: Long-Standing Experience Saves Study Momentum
4/17/2023
Study transitions are inherently challenging. Here’s what teams should know to stay informed, keep processes aligned, and successfully transfer data.
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To Placebo Or Not To Placebo? The Great Debate In Rare Disease Trials
4/17/2023
Consider the severity of the disease, the availability of existing therapies, and more when deciding whether or not to use placebo control in rare disease trials
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5 Things To Know About Bayesian Response-Adaptive Design
3/30/2023
For sponsors considering a Bayesian response-adaptive style design, review this guide for tips to consider prior to developing a clinical study protocol.
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Patient Centricity In Rare Disease: 5 Ways To Maximize Engagement
3/30/2023
Sponsors looking to differentiate their trials and inspire patient interest should consider these five tips to proactively demonstrate their commitment to addressing unmet therapeutic needs.
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Executing A Dual-Submission Study
3/20/2023
Dual submissions can pose a range of difficulties for clinical trials. Gain insight into how multiple requirements can be addressed successfully with the right strategy.
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Establishing Clinical Utility Of Molecular Diagnostics For Precision Medicine: 5 Tips On RCT Conduct
3/20/2023
Explore five ways to approach designing and conducting a randomized clinical trial to demonstrate clinical utility.
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IVDR Survival Guide Part 1: Classification, Clinical Evidence, & Performance Requirements
3/20/2023
Have common questions concerning the IVDR product classification system addressed and learn how to comply with new clinical evidence and performance expectations.
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Rare Disease And Precision Medicine: A Road To Growth
3/16/2023
As precision medicine advances, discover how the timing of rare disorder diagnosis could be improved so that treatment can begin at earlier stages of the illness.