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EDC Study Design
Our study design experts deliver high-quality calendars and forms in Advarra EDC utilizing best practices in data capture and form design.
How Centralized IBC Review Can Benefit Gene Therapy Research
Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
Until the 1980s, children were excluded from research studies. Now, FDA provides draft guidance on ethically including kids in trials.
Advarra Is Ready for the Revised Common Rule
Advarra has revised its policies and processes to be fully compliant with the Revised Federal Policy for the Protection of...
Advarra Resources for Revised Common Rule Now Available
Several new new and updated Advarra client resources are now available in preparation for the January 21, 2019, revised Common Rule compliance date.
Advarra Guidance on Compliance with the Revised Common Rule ICF Changes Now Available
Advarra guidance on complying with revised Common Rule ICF changes is now available for clients.
What Is an Institutional Biosafety Committee?
An institutional biosafety committee (IBC) ensures research is conducted safely and in compliance with the NIH guidelines. Watch our video to learn the role of an IBC.
Safety Precautions for Laboratory Research With COVID-19 Specimens
The pandemic has brought biosafety to the spotlight. This blog discusses guidelines and safety precautions for handling COVID-19 specimens.
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Submitting an Investigational New Drug (IND) application for the first time? Consider three common CMC pitfalls that may impact submission.
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.
Advarra Announces Release of Insights Accrual Prediction Platform, A Next-Generation Accrual Prediction Solution For Clinical Trials
Insights Accrual Prediction platform leverages machine learning to accurately predict protocol accrual, strengthening clinical research success. (COLUMBIA, MD., April 1,...
Why do Funding and Legal Structure Matter in Decentralized Clinical Trials?
Both sites and sponsors must consider how DCT funding and legal structures can impact sites and the study itself.
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