Budgeting for IRB Review: A Guide for HRPP Leadership
At institutional research programs around the U.S., there exists a pervasive myth: internal institutional review board (IRB) reviews are free. […]
Metrics and Analytics
Clinical Trial Efficiency: Top Risk Indicators and Solutions for Site Performance
Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study managers, and startup specialists collaborate
Our OnCore CTMS Vision: Building a Foundation for Success
OnCore’s future vision focuses on cloud-hosted solutions, cross-platform reporting, and SSO, enhancing efficiency and user experience for research sites.
What is a Data Monitoring Committee?
DMCs play a vital role in clinical trials by independently reviewing interim data for safety and effectiveness, ensuring participant protection throughout the study.
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.
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. While drugs
Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials
How do you know your experimental therapy is working? Sometimes, it can be as simple to determine as comparing drug
What is a Quality IRB Review?
Metrics in general are one of the ways we can gauge how well a program or service delivers. In the
Privacy Regulations Impact on Global Clinical Trial Endpoint Adjudication
New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g.,
Streamline Study Startup with Improved Site Selection & Feasibility
Site selection for clinical trials is often one of the biggest headaches for pharmaceutical sponsors and contract research organizations (CROs).
Beginner’s Guide to Clinical Trial Billing Compliance
Understanding clinical trial billing rules, from Medicare policies to state laws, is crucial for avoiding compliance pitfalls and supporting trial integrity.
Beginner’s Guide to Clinical Trial Management Systems
From the largest research centers to the smallest, sites now recognize that a clinical trial management system (CTMS) can be configured to their needs and can bring powerful efficiencies insights, and compliance to their day-to-day operations.