Quality Control and Assurance

Our comprehensive quality control and assurance program ensures that all clinical trials comply with Good Clinical Practice (GCP) guidelines and our internal quality standards.

Quality and regulatory MC Research experts thoroughly review and customize the protocols to ensure they are specifically tailored to each research project and meticulously align with all relevant laws and regulations.

This study focuses on providing an overview of the quality control and assurance plan for clinical research services in the pharmaceutical and biotech industry. 

The study design and protocols cover various aspects such as inclusion/exclusion criteria, endpoints, procedures, and data collection instruments. Quality control and assurance processes are outlined, including data validation, source data verification, monitoring, auditing, and training.

Quality control and assurance

The study management and oversight, investigator training, data management, vendor qualification, risk management, safety reporting, training and education, recordkeeping, and quality metrics are also described to ensure adherence to ethical and regulatory requirements and to evaluate the success of the quality control and assurance plan.

Comprehensive Quality Control and Assurance

The Quality Control and Assurance – MC Research Service summarizes the critical components of the quality control and assurance plan and reiterates the importance of complying with all applicable laws and regulations.

By upholding these standards, the plan safeguards the accuracy, completeness, and ethical conduct of the research, instilling confidence in the outcomes and promoting the well-being of study participants.

Quality Control and Assurance - MC Research Service

Ensuring Compliance and Quality are the Key Elements of the Quality Control and Assurance Plan at the MC Research

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