Case Study
AAHRPP Accreditation Support
Clear and useful guidance enables BC Diabetes to clearly demonstrate its commitment to research excellence during the AAHRPP accreditation process.
GDPR Implementation Support
Expert assistance from Advarra's regulatory consulting team enabled iSpecimen to implement GDPR with no service interruption to their Eurozone customers.
EVAL Case Study with Case Comprehensive Cancer Center
As the Case Comprehensive Cancer Center approached their recent CCSG renewal, their team recognized they needed a better system to store and analyze CCSG requirements, including grants, publications, investigators, pilots, and more.
For-Cause Investigation of Potential Misconduct and/or Fraud at Two of Site Management Organization’s Locations
When the owners of a clinical research organization suspected fraudulent activity that could potentially impact data integrity…
Advarra Consulting helped a site management organization pinpoint and correct suspected fraud at two study sites. Read more about Advarra’s investigation into the misconduct in this case study.
Karmanos Cancer Institute Unites Operational Teams and Creates Optimized Processes
Team members at the Barbara Ann Karmanos Cancer Institute recognized the importance of operational efficiency, and investigated ways they could gather and present operational data they had already collected to identify areas of success and opportunities for growth.
Inventory, Quality Control and Scanning of Trial Master Files
Advarra Consulting assists a small specialty biopharmaceutical company in upgrading storage of TMFs to a comprehensive electronic filing system.
Advarra Consulting assists a small specialty biopharmaceutical company in upgrading storage of TMFs to a comprehensive electronic filing system.
Evaluation of Clinical Systems Requirements
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.
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.
Process Assessments Lead to a Successful Mock FDA Inspection
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.
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.
Clinical Quality Assessment & Corrective Action Initiatives
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 ...
Advarra Consulting helps implement a highly compliant clinical trial infrastructure at a mid-size device company.
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