CRO
The GDPR and Its Impact on the Clinical Research Community (Including Non-EU Researchers)
Please note that this material is provided for informational purposes only and not for the purpose of providing legal advice.
Integration Update: Recent Milestones Completed
The Advarra team has worked to fully integrate our processes and policies to provide clients with unified capabilities and support for IRB, IBC and global research quality and compliance consulting services.
Integration Update: Expanded FAQ for Advarra Merger Efforts
The following FAQ expands upon previous FAQs we’ve published and provides additional insight into the integration process.
International Research and Research Ethics Review
Clinical research continues to grow throughout the world, with researchers looking outside the US for new and diverse subject populations to help develop and improve investigational therapies. Lauri Carlile, VP of Operations at Advarra, discusses the basics of ex-US research ethics review for US-based researchers.
Clinical Research Acronyms and Abbreviations You Should Know
New to clinical research? Learn the meaning of common industry acronyms and abbreviations including eCRF, IIT, PI, TMF, and more.
Integration Update: Revised FAQ for Advarra Merger Efforts
Since November 2017, the Advarra team (formerly Chesapeake IRB and Schulman IRB) has been working to integrate our process and policies. We are committed to being transparent throughout this integration, so we've assembled the following FAQ to keep you updated.
Schulman IRB and Chesapeake IRB Merger and Integration: What You Need to Know
Chesapeake IRB and Schulman IRB are merging under the new organizational name, Advarra. This FAQ addresses commonly asked questions about this merger.
Informed Consent in Research and Individuals with Impaired Decision-Making Capacity
This blog outlines the principle of equitable selection and the requirement for additional safeguards for certain vulnerable groups.
Non-English Speaking Research Subjects: What’s in the Regs?
Recently, the clinical research community has been making efforts to include more diverse subject populations in clinical studies.
Evaluating eConsent: Some Considerations from an IRB Perspective
eConsent technology can often better inform participants than just the traditional paper consent, which is great from an IRB perspective.
Planning Gene Therapy Research? Plan for IBC Review
The completion of the human genome project and advances in genetic engineering have paved the way for clinical trials involving human gene transfer
Component Analysis: Analyzing Benefits and Risks of Individual Interventions to Ensure Appropriate Research Participant Protections
A major element of any IRB review is the examination of potential benefits and risks to study participants.