WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,

FLORIDA,

United States,

ZIP: 33021

Phone: 347 282-5400

Description

Quality and Quality Assurance are very important to virtually all aspects of Clinical Research. The FDA requires certain Quality Assurance practices to know things are being done to the best quality. Clinical trials form the basis for much of the research done for new drug approval. While the study is being conducted QA procedures must be applied to assure good quality results.

 

Areas Covered

 

The course will cover the areas or topics that typically need to be monitored during the three parts of a clinical trial – Study Start-up, Study Execution, and Study Close-out. This will include things done by the Sponsor, The Site seeing the patients, and sites that are supporting the study, such as laboratories.

 

Who will Benefit

 

Those at the sponsor that are responsible for the conduct of the study.
The medical staff that see the patients during the trial.
Those working in a laboratory that is processing samples

 

Richard Chamberlain has a Ph.D. in Statistics and has consulted with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of Computer Systems Validation, Data Management, computerized project scheduling, strategic planning, and Quality Management.