Clinical QMS – Choose Agatha Quality as your clinical quality management system

Improved patient and consumer safety

A clinical QMS generates reliable data that an organization, its partners, regulatory and healthcare authorities, and other stakeholders can use for monitoring and improving clinical products and the lives of patients. Using a clinical QMS such as Agatha Quality gives clinical trial participants and end users of the results of clinical research the assurance that medications/treatments that they receive were developed using proper research.

Guaranteed regulatory compli­ance throughout the research process

Managing quality through a central application ensures regulatory compliance during the entire clinical trial process. This risk mitigation will include first-in-human studies to post-marketing surveillance of new pharmaceutical products.

Improved clinical research quality management

Reduce or eliminate repetitive quality issues during clinical studies such as unintentional non-compliance, insufficient staff training, insufficient supervision by management, lack of protocol clarity, and insufficient quality control in the collection and recording of data threatening patient safety/data integrity.

Agatha Quality clinical QMS offers a strong organizational structure to help pharmaceutical businesses systematically improve the overall performance of their clinical research, accomplish their quality control and training goals and complete clinical trials efficiently.

Proactive approach to quality assurance

A reactive approach is not enough for a quality management system (CQMS): good risk management practices are essential. Proactively managing clinical quality with a well-designed CQMS instead of reacting to issues related to investigational products when they occur avoids wasting valuable time and resources.

The main regulatory requirements for any project of clinical research or clinical investigation conducted by an organization are:

Good clinical practice (GCP)

“Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).”

ISO 14155:2020

The ISO 14155:2020 “specifies general requirements intended to:

• protect the rights, safety and well-being of human subjects,
• ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
• define the responsibilities of the sponsor and principal investigator, and
• assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.”

European Medicines Agency clinical trials regulation

Regulation (EU) No 536/2014 states that:

“In a clinical trial the rights, safety, dignity, and well-being of subjects should be protected and the data generated should be reliable and robust. The interests of the subjects should always take priority over all other interests.”

The core elements of an effective digital quality strategy involve the following elements:

• Processes;
• Resources;
• Roles and responsibilities;
• Partnering;
• Risk management;
• Issue management;
• Knowledge management;
• Documentation that supports achieving quality;