Research Operations
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.
Understanding how to Build and Leverage a DSMB Statistical Plan
Find out about the DSMB statistician’s roles, how study design can impact DSMB analysis, and what goes into a DSMB statistical plan.
What is a Quality IRB Review?
Measuring IRB quality is often an effort to determine whether an IRB’s actions improve research participant protections.
Is Your Site Ready for an FDA Inspection?
Understand the FDA’s expectations for a site inspection, GCP compliance, and maintaining study integrity.
Beginner’s Guide to Medicare Coverage Analysis
Medicare coverage analysis evaluates how clinical research protocol items and services are billed per federal agency guidelines.
Trend Report: 2023 Trends Impacting Clinical Research
This report defines 2023 clinical research trends and provides an outlook for the industry moving forward.
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.
Investigating Enrollment Reliability with the Longboat Platform
Download the case study to learn if the Longboat Platform helps sites more accurately set and reach their patient recruitment targets.
How to Optimize Your sIRB Experience
Find out how other institutions have used sIRB requirements as an opportunity to elevate their research programs in this webinar.
Beginner’s Guide to Budget Negotiation
Proper trial financing ensures internal costs are covered, facilitates better negotiation, and leads to higher compliance in trials.
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