Education/Training  
     
 

International GCP guidelines emphasize the significance and importance of training and education for all clinical research personnel:

Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s) (ICH GCP 2.8).

Adequate qualification is a key prerequisite for the ethical conduct and management of clinical trials: at the sponsor, at Contract Research Organizations (CROs) or investigator sites. Customized education modules and training opportunities are developed together with the client to best serve the audience.

Verdandi offers courses and seminars in the following areas:

Clinical Drug Development: Trial Design and Phases
ICH GCP Requirements for the Conduct of Clinical Trials
ICH Guidelines beyond ICH GCP
FDA IND Requirements for the Conduct of Clinical Trials
EU Clinical Trials Directive
GCP and GMP Requirements for Investigational Medicinal Products
Quality Management Basics: SOPs, Quality Control, Quality Assurance

 
Quality Assurance Audits for Clinical Trials:
Focus, Scope, Approach, Conduct, Follow-up
Quality Issues and Audit Findings in Clinical Trials

 
Regulatory Authority (FDA, EMEA etc.) Inspections of Clinical Trials:
How to prepare – How to manage – How to follow-up
Standard Operating Procedures