Optimizing Your Human Research Protection Program: The Role of Quality Training
As research institutions are designing studies and recruiting participants for them, they must maintain compliance and ensure their study is […]
Research Compliance
What is an sIRB and Why Does my Study Need One?
Single IRB (sIRB) review streamlines oversight for multisite trials, reducing administrative burdens while ensuring participant protections across all sites.
Understanding Various Site Use Cases for eSource and EDC
Sites can improve data capture, management, and compliance using a site-centric eSource or EDC platform, supporting smoother workflows, remote monitoring, and efficient data analysis.
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
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
What Are the Phases of Clinical Trials?
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.
How Data Safety Monitoring Boards Support Safe and Ethical Clinical Trials
Data Safety Monitoring Boards (DSMBs) play an important role in protecting participants and supporting the scientific integrity of clinical trials.
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