Short Form Consents and the Unexpected Non-English Speaking Participant
What happens when an unexpected non-English speaking participant shows up, and there isn’t enough time to obtain a translated study consent?
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Global & FDA regulations dictate how researchers organize & store trial documents. Learn the basics of eTMF & eISF clinical research tools
Developing an Enterprise Roadmap to Post Authorization Safety Studies
Learn how an organization achieved organization-wide compliance and managed its post-authorization safety studies.
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.
Return of Research Results to Study Participants
Research into participant experiences has consistently shown their desire to learn the results of research to which they’ve contributed.
Common Pitfalls in Preparing an IND Application
While the IND application process may be straightforward to some, we explore the most common pitfalls as sponsors prepare for submission.
IRB Review of Decentralized Trial Technology
Explore the current regulatory landscape governing mHealth and virtual trial applications in clinical research.
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.
Four Questions to Ask When Establishing a Pharmacovigilance Organization
Four common but critical questions for emerging biotech organizations establishing a pharmacovigilance (PV) organization.
A Checklist for Optimizing Clinical Trial Study Startup Activities
This checklist outlines key milestones and considerations for sites and sponsors in the clinical trial study startup process.
Best Practices in Pre-Screening Includes Use of Technology
Explore the benefits of pre-screening potential participants before they move on to the informed consent process.
Common Elements of IRB Assessments
Like other IRBs, Advarra is subject to inspections from time to time. What standards are we measured against?