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…