NIH 2023 Data Management and Sharing Policy: What you Need to Know
Optimizing Your Data Management Plan: Best Practices for Biomedical Research under the NIH Data Sharing Policy
Honoring Clinical Trailblazers: 2023 Video Series
This series celebrates the groundbreaking achievements of four pioneers who defied the odds to change the course of clinical research forever
Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials
Trial designs incorporating multiple endpoints to support efficacy are receiving increased focus from the FDA, including a recently published guidance.
What is a Quality IRB Review?
Measuring IRB quality is often an effort to determine whether an IRB’s actions improve research participant protections.
Beginner’s Guide to Medicare Coverage Analysis
Medicare coverage analysis evaluates how clinical research protocol items and services are billed per federal agency guidelines.
Developing and Implementing a Successful eConsent Process
As the industry continues to shift from brick-and-mortar trials to more convenient hybrid formats, eConsent proves to be useful.
Privacy Regulations Impact on Global Clinical Trial Endpoint Adjudication
Endpoint adjudication committees must keep up with rapidly developing requirements as they receive potentially identifiable research data.
Why Now is the Right Time to Adopt eConsent
A valuable tool for both sites and participants, now is the right time for sites to adopt an eConsent platform.
Beginner’s Guide to Budget Negotiation
Proper trial financing ensures internal costs are covered, facilitates better negotiation, and leads to higher compliance in trials.
Beginner’s Guide to Single IRB Mandates
More governing bodies are starting to opt for single institutional review board (sIRB) review as a way to streamline research operations.
Medicare Coverage Analysis Worksheet
Determine whether your trial meets the requirements of the National Coverage Determination (NCD) for Routine Costs in Clinical Trials.
Your Guide to sIRB Mandates
sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.