GxP Auditing, Compliance, and Specialized Consulting
Advarra’s experts can work directly with your team to provide consulting and evaluation services related to GCP, GMP, GLP, GVP, GDP, and quality assurance (QA).
Study Activation Consulting
Make your clinical trial operations more competitive and your study activation process more efficient with a comprehensive assessment, best practices guidance, and implementation support from Advarra.
Staff Augmentation
A successful institutional research program depends on a reliable and well-functioning clinical operations department and IRB. With IRB and research technology experts ready to hit the ground running on-site or…
Research Administration Consulting
Strong research administration infrastructure is critical for success in today’s changing regulatory and business climate. Advarra Consulting helps you to address the challenges of discovery science, translational research, and clinical…
Part 11/Annex 11 Independent Audit and Compliance Assessment
Independent verification of compliance opens new doors for CRIO, Inc. and provides customers confidence that they can incorporate the eSource system into their own computer software validation strategy.
Comparative Analysis for Non-IND Sites
Advarra Consulting provides in-depth analysis of German, European, and US regulations, allowing a cancer research study to move forward.
The Convergence of GDPR, the HIPAA Security Rule, and Part 11 on US Clinical Research
As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new…
GMP Consulting Services Menu
Advarra helps clients minimize risk and maintain compliance with good manufacturing practice (GMP), good laboratory practive (GLP), and good tissue practice
Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative
Advarra regulatory expert David Babaian contributed to an article about decentralized clinical trials, published in Therapeutic Innovation & Regulatory Science
A Tale of Two Sites: The Power of Integrated Research Administration
Site timelines for studies can vary widely across the industry due to differences in internal efficiency. In this blog, James Riddle (Advarra VP of Institutional Services and Strategic Consulting) tells…