GCP

Good Clinical Practice is at the heart of a viable and consistent clinical study. At any phase, maintaining proper procedures is vital to build good relations with regulators and the public. As with any complex system of guidelines, constant oversight and proper training prove invaluable to a smooth and efficient clinical trial.

Auditing

Compliance with Good Clinical Practice (GCP) is critical in ensuring that organization will avoid expensive delays. Our experts apply industry and regulatory agency experience in ensuring compliance with all aspects of designing and executing a successful clinical trial including:

  • Establishment of an audit program including the review, creation and updating of your Standard Operating Procedures (SOPs)
  • Development of tools and templates for auditing clinical sites, CROs, clinical data, and internal clinical files
  • Creation of a GCP training program that allows your team to develop skills to manage audits autonomously
  • Trend analysis of clinical data
  • Documentation of audit report findings and
  • Review of informed consent requirements and HIPPA privacy regulations

More About Auditing

Training

GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies. GCP compliance provides public assurance that the rights, safety and well-being of human subjects involved in research are protected. To protect these rights, safety and welfare of humans participating in research. To assure the quality, reliability and integrity of data collected To provide standards and guidelines for the conduct of clinical research Good Clinical Practice = Ethics + Quality Data.

More About Training