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.

Case Study

Clinical Quality Assessment & Corrective Action Initiatives

March 30, 2018

Advarra Consulting helps implement a highly compliant clinical trial infrastructure at a mid-size device company by identifying areas of need with an SOP Gap Analysis, developing new standards and training…