What is Quality Assurance?

The importance of quality in clinical trials is fundamental to ensure patient safety and the validity of the results obtained. According to a survey conducted by @TransCelerate BioPharma, 86% of the surveyed companies consider quality assurance important to certify the quality of the data generated during clinical trials. It is necessary to implement measures and controls that ensure data integrity, patient safety, compliance with ethical and regulatory standards, and various tools can be mentioned for this purpose:

  1. Risk analysis is a crucial tool in clinical trial management. According to a study by the @Tufts Center for the Study of Drug Development, risk analysis has become a standard practice in risk management in drug development, with 80% of respondents considering it essential for risk management in clinical trials. Additionally, according to a report by the @FDA, risk analysis can also help reduce time and costs in drug development, allowing for faster commercialization. In summary, risk analysis is a crucial practice in clinical trial management that can improve safety and efficiency in drug development.
  2. A document system is a fundamental tool in clinical research management, as it allows for ensuring the integrity and traceability of the data generated during the study. According to a study by the @Society for Clinical Data Management, 63% of respondents consider the document system important to guarantee data quality in clinical trials. Furthermore, the same survey revealed that 42% of respondents identified the lack of a document system as the primary cause of data quality problems in clinical trials. The implementation of an adequate document system can help avoid errors, ensure data consistency and integrity, and facilitate compliance with regulations and ethical standards in clinical research. Therefore, it is essential for clinical researchers to consider the implementation of an effective document system at all stages of the study to ensure the validity and quality of the data generated.
  3. Audits are a vital tool in clinical trial management, as they allow for identifying and correcting errors and deviations in processes, ensuring compliance with regulatory and ethical requirements. According to a study by @Applied Clinical Trials, 67% of respondents consider audits essential to ensure compliance with regulatory requirements, ethical standards, and procedures established in clinical trials. Additionally, an FDA study found that 45% of the problems detected in clinical trials could have been avoided if effective audits had been conducted. In conclusion, audits are a key tool in clinical trial management and must be implemented effectively to ensure the quality and safety of the data generated during the study.

According to a report published by the FDA, effective quality assurance implementation can reduce the number of errors and problems by 50% during the clinical trial development process. Furthermore, a systematic review of studies published in the journal Therapeutic Innovation and Regulatory Science found that the lack of quality assurance in clinical trials can lead to inaccurate or imprecise results in up to 30% of cases. These statistics highlight the crucial importance of ensuring that a solid quality assurance system is implemented in all phases of clinical research.

The quality assurance department plays a fundamental role in the development of clinical trials. It is responsible for ensuring that regulatory requirements, ethical standards, and established procedures are met during all stages of the study, ensuring the validity and quality of the results obtained.
Do you want to know more about how the quality assurance department handles risk management in clinical trials? Or perhaps you are interested in learning how audits are conducted to ensure compliance with regulatory and ethical requirements? Do not hesitate to ask! We are here to help you understand the importance of this crucial department in the success of clinical trials.

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