Consulting
Integration Update: Leading Compliance Adherence
The Advarra team is proud to announce that all major integration activities are now complete.
ICH-GCP Guidelines and Research Conducted in the US
Learn the basics of how ICH-GCP Guidelines can impact the study ICF and how we at Advarra came to our updated policy on the topic.
What’s the Difference Between Right to Try and Expanded Access?
Let’s take a look at the basics of what each program does and does not do for patients seeking to access investigational therapies.
The EU General Data Protection Regulation: Implications for Research
Leslie Thornton and Nick Wallace provide an introduction to the GDPR and its potential application to the US-based research community.
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.
Inventory, Quality Control and Scanning of Trial Master Files
Advarra Consulting assists a small specialty biopharmaceutical company in upgrading storage of TMFs to a comprehensive electronic filing system.
Evaluation of Clinical Systems Requirements
Advarra Consulting assesses a mid-size device company's processes, determining the need for new and modified electronic systems and processes and proposing a CTMS.
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.
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