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Meeting the Challenges of Investigator-Initiated Trials
How does investigator-initiated research differ from other types of clinical research? Advarra IRB Chairperson Robert Romanchuk explains.
Services for Research Staffing
Fill short- and long-term core team roles both on-site and remotely to bring industry-leading skills to your projects.
Reporting to the IRB: What NOT to Report
Reportable events can be tricky: according to the regulations, not every unanticipated event should be submitted to the IRB.
Connecting Patient Centricity and eConsent Together
eConsent is a way to enhance the patient experience through improved study design, retention rates, and communication.
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?
Ensuring a Successful and Collaborative SDLC Process
Find out how Advarra's approach to the SDLC lifecycle leads to successful collaborations among sites and sponsors.
Beginner’s Guide to 21 CFR Part 11 Compliance
FDA released regulations in 1997 outlining how 21 CFR Part 11 applies to electronic records and electronic signatures in clinical research.
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.
Advarra, Leading Provider of Life Sciences R&D Compliance and Technology Solutions, Secures Major Investment from Blackstone and CPP Investments
Investment will support next growth phase in Advarra’s journey to make clinical research safer, smarter, and faster (Columbia, MD) –...
What Do Auditors Look for When Performing SDV and SDR?
Understanding what auditors look for and why when conducting SDV and SDR will help ensure your next site audit goes well. Read more:
Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance
A robust corrective and preventive action (CAPA) stands as a critical tool for proactively addressing deviations in clinical research.
Coronavirus Resources for Sponsors and CROs
Need rapid startup support for vaccine and gene therapy trials? Contact our Biosafety Services for IBC reviews in as little...
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