With over two decades of combined expertise in providing Quality Assurance and Data Privacy services to the highly regulated life sciences industry, in pharmaceutical, biotechnology and medical devices, the Axiom Real-Time Metrics Quality Assurance and Data Privacy leadership can address your current needs, reduce compliance risks, and mitigate issues.
1. Client Discussions on Protocol, Data Management Plan Structure • Regular discussions to ensure the protocol/therapeutic requirements are understood and the approach to the DM plans reflects the study needs.
3. Data Breach Management • Documentation, reporting, risk assessment, and mitigation of events that compromise the integrity, confidentiality, or availability of information. • Including unauthorized use or disclosure of regulated data, i.e. personal identifiable information or protected health information regardless of the party responsible for the action (i.e. Site, Sponsor, etc.).
4. Inspection Readiness/Management • Pre-inspection preparation, hosting inspection support, and post-inspection activities ○ Regulatory trend assessments (hot topics of intensified scrutiny for inspectors), assistance with Sponsor departmental/scenario-based storyboards, rapid response team implementation, Inspection conduct training Sponsor/Site level, etc.
5. Internal Audit Plan • Development and / or execution of a Sponsor Internal Audit Plan, or conduct select Internal Audits.
7. Quality Agreement • Establishes the quality assurance activities supporting the clinical trial. ○ Including quality related KPI reporting. • Specifies applicable timelines.
8. Quality Governance Meetings • Platform for clinical quality consultation ○ Discussions of overall compliance with regulatory requirements, industry standards, and continuous quality improvement. – Including the discussion of clinical trial-based scenarios and corresponding mitigative actions.
9. Training Management Plan • Provides training and the retention of training materials and associated evidence of training completion on Axiom or Sponsor procedures. • GCP Training ○ ISO 14155 – Medical Devices ○ ICH E6 – Drug Biologics
10. Vendor Qualification Schedules • Develop and / or execute a Sponsor Vendor Qualification/Re- Qualification Schedule, or conduct select Qualifications/Re-Qualifications.