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.
Advarra Integrates IRB with Veeva Vault eTMF, Delivers Unparalleled Efficiency for a Top 10 Biopharma
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.
Advarra Consulting provides in-depth analysis of German, European, and US regulations, allowing a cancer research study to move forward.
Clear and useful guidance enables BC Diabetes to clearly demonstrate its commitment to research excellence during the AAHRPP accreditation process.
Expert assistance from Advarra's regulatory consulting team enabled iSpecimen to implement GDPR with no service interruption to their Eurozone customers.
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 assists a small specialty biopharmaceutical company in upgrading storage of TMFs to a comprehensive electronic filing system.
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 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 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…