Advanced Postgraduate Diploma in Clinical Research & Quality Assurance

Clinical research industry has achieved significant growth in the last 10 years. This growth is closely linked to an increased focus on quality in executing clinical trials. Quality systems need to be incorporated into the clinical research processes right from the planning stages and strict regulatory standards need to be maintained by all responsible parties throughout the conduct of the clinical trials. Although Quality Assurance was initially a concept limited to manufacturing, over the years Clinical Research Quality Assurance has turned out to be an important tool, in guaranteeing that developments are carried out within a rigorous quality framework.

“Quality is never an accident; it is always the result of intelligent effort” ... J. Ruskin

Maintaining Quality throughout a clinical trial is an ongoing process. The Quality Assurance (QA) function within an organization includes all Quality Control (QC) activities and serves as a link between the tasks conducted during clinical trial monitoring and the regulatory inspections (e.g. FDA inspections). Clinical Quality Assurance facilitates achieving standardization and maintaining consistency at each step of the clinical trial process. Clinical Quality Assurance (QA) tasks include developing and maintaining compliant standard procedures within the organization; planning, scheduling, and conducting site and system audits; assessment of quality level; & compliance with local & international guidelines and regulations as may be applicable.

This Advanced Clinical Research and Quality Assurance Training Program has been conceptualized and designed to meet the growing demand of the industry for professionals with clinical quality assurance training.