APPLICATION OF REGULATORY GUIDANCE & GOOD CLINICAL PRACTICES (GCP) TO ENSURE CLINICAL DATA INTEGRITY

As pharmaceutical manufactures increasingly outsource various clinical research processes and procedures, accurate and reliable data generation from a trial’s inception to archival is increasingly critical. To mitigate instances of data inaccuracy and corruption, leading regulatory authorities have released various guidance documents and recommendations for validating clinical data integrity as a result of multiple instances involving data inaccuracies, corruption, and violations. To ensure success in clinical studies,  manufacturers must have a thorough understanding of related regulatory requirements and recommendations while taking a cross-functional approach to developing flexible clinical data integrity systems.

• Perspective on Clinical Data Integrity (components, enablers, definitions
  • Differentiating quality from integrity
  • Systems Validation and Data Integrity in clinical development
• Cultural Awareness and Process considerations for global an local clinical teams
  • The evolving role of Clinical Data Scientists and Stewards
  • The dawn of Digital Clinical Data
• Guidance and feedback from regulators in the evolving clinical landscape

 

Speaker:
Thomas Haag
Global Head Digital Development & Transformation QA,
Novartis Development Quality Assurance Operations

Contact:

Brooke Akins | Division Director, Life Science Programs
312.224.1693 | webinars@q1productions.com