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    Ethics and Compliance

    Each day, our employees engage patients and healthcare organizations as part of our clinical services programs. We recognize that every aspect of our activities, from how we conduct clinical trials, to the way we interact with customers, partners, and colleagues must be guided by our Ethics and Compliance Program, which encompasses our values and a clear understanding of legal and regulatory requirements, company policy and procedures.  At ProMedDx, we do more than comply with law and regulations.  We aim to do what is right, each and every day.

    An essential element to our Ethics and Compliance program is our Bioethics policy.  How we engage, conduct, and protect patients, their rights and private information is woven into all of our core processes.  These include:

    Clinical Protocols

    Reviewed and approved by: Institutional Review Board (IRB) and/or Ethics Committee

    Clinical Programs

    Conducted in accordance with:

    • Good Clinical Practice (GCP, ICH E6)
    • Health Insurance Portability and Accountability ACT of 1996 (HIPAA)
    • Declaration of Helsinki
    • Department of Health and Human Services (DHHS):
      • 45 CFR 46, 160 and 164
    • US Federal Regulations:
      • 21 CFR 50 Protection of Human Rights
      • 21 CFR 56 Institutional Review Boards
      • 21 CFR 54 Financial Disclosure by Clinical Investigators

    BioRepository Operations

    Governed by Stringent Processes and Expert Staff

    • 75+ Standard Operating Procedures (SOPs)
    • Quality Management Program (QSR, 21 CFR 820)
    • Good Manufacturing Practice (cGMP)
      • Biologics (21 CFR 606)
      • Human cells, tissues, and cellular – tissue-based products (HCG/Ps; 21 CFR 1271 Subpart D)
    • Good Laboratory Practices (GLP)
    • 21 CFR 11-compliant Rockhopper™ data management system
    • 21 CFR 11-compliant temperature monitoring system
    • Certified Clinical Research Associates (CCRAs)
    • Full-time quality assurance team, responsible for the monitoring and oversight of all clinical operations.

     

    Testimonial Header Image

    "ProMedDx’s team support and Biorepository has allowed us to quickly troubleshoot, identify, and respond to client observed performance of our testing systems.”

    - Senior Quality Project Engineer, European-based global provider of Diagnostic Assays