GCP 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

Training Programs

Our Experts can assist with the development and delivery of effective training programs to address the following key aspects of Good Clinical Practice specifically tailored to your project:

New Regulations for Expanded Access and Compensation

Investigator Responsibilities - Regulation and Clinical Trials

Informed Consent and Ethical Considerations in Clinical Trials

Ensuring the Quality of a Drug used in a Clinical Trial

  • CMC and the Investigator Brochure (Drugs)
  • CMC and the Investigator's Brochure (Biologics)
Investigator Brochure Development
  • Pharmacotoxicology
  • Clinical pharmacology Phase 1 Trials, Early Drug development
  • Clinical pharmacology Phase 2 Trials
Clinical Trial Protocol Development
  • Design of Clinical Trials
  • Clinical Trial Endpoints
  • Issues in Clinical Trial Designs for Devices
  • Issues in Clinical Trial Design for Diagnostics and Combination Products
  • Analysis of Investigator Data, Sources of Bias and Error
The Application Process
  • General issues in the Safety of Clinical Trials
  • Clinical Discussion of Special Populations
    • Hepatotoxicity
    • Pediatric studies
    • Immune compromised
  • How to put together and application
  • Ensuring the Safety of Clinical Trials, AE Reporting, DSMB's and IRB'
  • FDA Perspective on International Studies