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.
Trend Report: 2023 Trends Impacting Clinical Research
This report defines 2023 clinical research trends and provides an outlook for the industry moving forward.
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.
Updated Advarra Fee Schedules Now Available
TAdvarra’s updated fee schedules for IRB, IBC, DMC, and EAC are now available. The new fee schedules are effective January 1, 2023.
Why Keep HIPAA Separate from the Informed Consent Form
HIPAA is important to the informed consent process, and oftentimes, a standalone document is the most beneficial approach.
Regulatory Trends in Cell and Gene Therapies
Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.
What Does an Endpoint Adjudication Committee (EAC) Do?
This white paper discusses an endpoint adjudication committee's (EAC) role in clinical research and the basics of setting up an EAC.
Advarra Trend Report: Current State of Trial Opportunity and Selection
Insights into the site selection process and the information sites provide as part of site feasibility questionnaire completion.
Top Barriers to Participation in Clinical Trials
Understanding the factors that influence the decision to participate in a study helps research professionals diagnose enrollment problems.
Patient Recruitment and Enrollment in Clinical Trials
Learn more about patient recruitment and enrollment: how they find out about clinical trials and the reasons they participate.
Becoming Your Own Best Advocate Through Patient Empowerment
In this episode, we discuss clinical trial patient empowerment and advocacy. We dive into health literacy and the informed consent process.
Establishing and Operating a DSMB: Tips for Clinical Trial Success
This white paper shares what a data safety monitoring board's (DSMB's) role is in clinical research and how it works.