Info Sheet

GxP Auditing, Compliance, and Specialized Consulting

March 10, 2020

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).

Info Sheet

Study Activation Consulting

March 4, 2020

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.

Info Sheet

Staff Augmentation

March 4, 2020

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…

Info Sheet

Research Administration Consulting

March 3, 2020

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…

Case Study

Part 11/Annex 11 Independent Audit and Compliance Assessment

February 28, 2020

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.

Case Study

Comparative Analysis for Non-IND Sites

February 28, 2020

Advarra Consulting provides in-depth analysis of German, European, and US regulations, allowing a cancer research study to move forward.

White Paper

The Convergence of GDPR, the HIPAA Security Rule, and Part 11 on US Clinical Research

February 28, 2020

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…

Info Sheet

GMP Consulting Services Menu

January 21, 2020

Advarra helps clients minimize risk and maintain compliance with good manufacturing practice (GMP), good laboratory practive (GLP), and good tissue practice

Abstract

Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative

December 20, 2019

Advarra regulatory expert David Babaian contributed to an article about decentralized clinical trials, published in Therapeutic Innovation & Regulatory Science

Blog

A Tale of Two Sites: The Power of Integrated Research Administration

October 23, 2019

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…