Standard Operating Procedures

Standard Operating Procedures


Standard Operating Procedures

FCR’s SOPs are based on applicable regulations and are the established standards for conduct of clinical trials within FCR. All clinical staff, including investigators, are trained on and adhere to these standards. Training on SOPs is required at hire, annually and upon revision or addition to the standards.

Quality Control

FCR's quality control includes regular, systematic evaluation of data collection, regulatory documents, monitor feedback and equipment maintenance/calibration, as well as observation and verification of clinical and laboratory skills. Continuous PI and Sub I oversight is ensured by the fact that all study visits are conducted by an MD. FCR adheres to the industry’s most stringent standards.

Quality Assurance

FCR's quality assurance is independent of clinical operations and is responsible for annual inspections of FCR facilities to ensure compliance with regulatory requirements, internal programmatic assessments and quality standards.

 

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