Device Risk Determinations for IVD Research
Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device […]
Research Compliance
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,
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.
Ace Your Next FDA Inspection
Adhering to FDA guidelines is crucial for sponsors and sites to ensure successful inspections, enabling product approvals and faster market access.
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.
Data Safety Monitoring Boards Facilitate Ethical Research
In clinical trials, the safety of research participants is paramount. An organization conducting or sponsoring clinical research can ensure participant
What Sponsors Need to Know About Medicare Coverage Analysis
With MCA processes slowing trial activation, AACI suggests sponsors play an active role in MCA preparation to reduce budget and startup delays.
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
Beginner’s Guide to IRB Review of IVD Research
IVDs diagnose and monitor health using biospecimens, often in labs. FDA-regulated but varied in compliance, IVDs require careful IRB review preparation.
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