Case Study

Large Hospital System Requires Central IRB Partner

April 7, 2020

From ad hoc IRB support to sIRB partnerships and fully managed IRB office services, Advarra has institutions and hospital systems covered. No matter how unique the situation, Advarra partners with…

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

Advarra Integrates IRB with Veeva Vault eTMF, Delivers Unparalleled Efficiency for a Top 10 Biopharma

February 28, 2020

Teamwork and leadership from an industry-leading biopharmaceutical company and Advarra accomplish integration through Veeva Vault eTMF, saving over 8000 hours in the first 6 months.

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.

Case Study

AAHRPP Accreditation Support

June 11, 2019

Clear and useful guidance enables BC Diabetes to clearly demonstrate its commitment to research excellence during the AAHRPP accreditation process.

Case Study

GDPR Implementation Support

June 11, 2019

Expert assistance from Advarra's regulatory consulting team enabled iSpecimen to implement GDPR with no service interruption to their Eurozone customers.

Case Study

For-Cause Investigation of Potential Misconduct and/or Fraud at Two of Site Management Organization’s Locations

January 31, 2019

When the owners of a clinical research organization suspected fraudulent activity that could potentially impact data integrity…

Case Study

Inventory, Quality Control and Scanning of Trial Master Files

March 30, 2018

Advarra Consulting assists a small specialty biopharmaceutical company in upgrading storage of TMFs to a comprehensive electronic filing system.

Case Study

Evaluation of Clinical Systems Requirements

March 30, 2018

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.

Case Study

Process Assessments Lead to a Successful Mock FDA Inspection

March 30, 2018

Advarra Consulting conducts process assessments and a mock FDA inspection at a small biopharmaceutical company to support the filing of their first new drug application to the FDA.