There is no doubt that medical science is reaching new heights every day. All processes related to FDA approval are becoming more advanced, systematic, and quick.
The same is true for clinical trial monitoring – a critical activity in drug development and marketing approval to ensure the quality of the research data and the protection of human rights, safety, and the well-being of human subjects.
In this blog, we will learn about the significance of clinical research monitoring services.
The Purpose of Clinical Research Monitoring
The following are some of the most common purposes for clinical research monitoring:
Ensure that the trial data reported and recorded is accurate, complete, and verifiable from source documents.
Ensure that the trial is carried out in accordance with the protocol, GCP (Good Clinical Practice), and the applicable regulatory requirements.
It is also worth noting that there are three types of monitoring in clinical trials:
On-site
Off-site (Remote Monitoring)
Centralized
Importance of Clinical Research Monitoring Service
Protect the Rights, Safety and Well-being of Human Subjects Involved
The paramount responsibility during the trial is to protect the subjects’ rights, welfare, and well-being. This can only be accomplished with the assistance of continuous monitoring of human subjects before, during, and after the trial procedure.
Nonetheless, clinical trial monitoring is a time-intensive and costly endeavour. This is where clinical trial monitoring organizations can help.
The clinical trial monitoring services provider will work with you to provide clarification and guidance, as well as develop educational programs and materials and maintain regulatory oversight. In addition, they advise on ethical and regulatory issues in clinical research.
In a nutshell, the clinical trial monitoring company will be responsible for overseeing everything related to human subjects’ well-being and ensuring their rights, welfare, and well-being.
Zenovel is among the top clinical research organizations in India that provides affordable and innovative solutions and services to the pharmaceutical industry. Some of the key clinical trial services offered by the company include GCP services, Regulatory Affairs Consulting Services, BA BE Services, GMP Audit Services, etc.
Zenovel has a global presence, with offices in India, the United States, Canada, Brazil, Australia and China. Over the course of 17 years, the company has successfully monitored and audited over 1700 clinical studies worldwide.
For more information read our blog: Importance and Purpose of Clinical Research Monitoring