Reporting Unexpected Incidents to the IBC
When unexpected events occur during the conduct of a clinical trial, research personnel may wonder if the event is reportable,
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New and Emerging CMS Policies: Medicaid’s New Clinical Trial Policy
The Centers for Medicare & Medicaid Services (CMS) released a letter outlining routine costs in clinical trials for patients eligible
Phases of Clinical Research: A Detailed Overview
Each clinical trial phase builds on the last, from initial safety to post-market studies, ensuring treatments are safe, effective, and beneficial for patients.
4 Unique Challenges of Oncology Trials
Oncology trials face unique hurdles in innovation, enrollment, and endpoints, requiring strategic planning to address complex study demands and precision needs.
Improving Study Activation Time for Gene Therapy Research
This blog explores how research sites are focusing on their institutional biosafety committee (IBC) programs as part of overall study activation time.
IBC vs. IRB: What’s the Difference?
Gene therapy research requires both IRB and IBC oversight—while IRBs protect participants, IBCs ensure community and environmental safety with local site-specific reviews.
Collaborating with Research Sites: Best Practices for Site Selection and Study Startup
The study startup process is a critical point in research, and oftentimes, can make or break a study’s success.
Key Efficiencies Driven by a Clinical Trial Management System
In today’s world of research, using a clinical trial management system (CTMS) can significantly streamline operations, and make for a
Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research
Clinical research aims to produce knowledge in the service of treating diseases and improving human health. In a just and
Patient Recruitment from a Site Perspective: Technology Meeting Today’s Challenges
Effective participant recruitment is crucial to a successful clinical trial, and as trials become more complex, the problem is intensifying.
Risk Assessment for use of Engineered Genetic Materials in Clinical Research
The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular
eReg Benefits for Clinical Research: Use Cases for all Types of Sites
While regulatory management takes time and effort, using an eRegulatory system can help staff boost productivity, improve compliance, and save resources.