Quality Management

A clear paper trail is essential to the validity and proper management of every clinical trial. Throughout the project, TCA quality management incorporates a systematic evaluation of all trial activity, documents and data. TCA provides Quality Assurance auditing for all clinical trials, assuring conformance to the highest GCP, GMP and GLP regulatory standards. TCA QA also addresses the Food and Drug Administration's (FDA) guidelines on how clinical data is collected, inputted and analysed. We incorporate quality assurance pre-planning into the protocol design and operational conduct of every client's clinical trial: From the pre-trial research stage right through to implementation and data analysis. Our systematic quality assurance methodology allows any potential issues to be identified and resolved at an early stage. Our QA is both consistent and dynamic, adjusting the mechanisms of the trial with changing expectations and requirements as the study evolves. At all times we ensure that every client's clinical trial is performed according to the protocol, standard operating procedure and good clinical practices. This achieves two-pronged quality assurance by securing patient protection with only the highest quality of data – thus ensuring your trial has trusted outcomes for a sustainable product.

Our QA services encompass the following:
  • Auditing
  • Phase I facilities
  • Phase I - IV GCP audits
  • Clinical laboratories (GCP, GLP)
  • Database and statistical tables
  • Computer validation
  • Clinical trial reports
  • Pre-FDA/regulatory inspections
  • Quality Systems Development (GCP, GLP)