As clinical research becomes more exacting, a need for measuring and controlling quality becomes imperative. This is where a quality management system (QMS) comes in.
A QMS (Quality Management System) is a control system used for planning and maintaining systematic procedures for improving quality. It usually comprises processes, guidelines as well as templates that lay out the standardized procedures needed to achieve high-quality output. This eliminates errors and mistakes, thereby cutting out the expensive costs of correction. In short, a QMS assures quality, reduces operational errors, and makes the clinical research process more affordable.
Some of the document types that a QMS helps clinical research labs to manage are:
Quality Manual: This provides a wide view of the organization and all its quality management processes
SOPs: Outline work processes and define the responsibilities of each staff
Templates: These are forms and document templates used for data entry and reporting
Records: Comprise of data, reports, documents
Importance of a QMS in Clinical Research Facilities
In clinical research, there is a legal obligation for the collection of traceable data and the production of reproducible results. Additionally, there is a responsibility toward research participants. Guaranteeing the dignity and privacy of study participants ranks high in the principles held by researchers and their staff.
To this end, a QMS aids in achieving the following:
- Safety as well as protection of the data of the study participants
- High-quality study data
- Creation of an overview and transparency of the activities of the study
- Necessary documentation
- Increased efficiency
- Guaranteed compliance with ICH-GCP, GDPR and other local and international laws
- Readiness for inspections by authorities
What Should be Included in a QMS?
Clinical research sites should implement a QMS to meet the objectives mentioned above. The staff working at the clinical site need to be adequately trained on the importance of the QMS and how to implement it appropriately. The following activities should be included in the clinical QMS:
Examples of SOPs to be Included in a QMS:
- Source Documents SOP: It describes the processes of generating and maintaining the source documents.
- Documentation Practices (GDP) SOP: It defines the documentation and correction processes of all the regulated data.
- Consent Process SOP: It defines the process of collecting and storing the consent of research participants.
- Continuity SOP: It outlines the process of study handover and training new staff to cover instances when staff change occurs.
- Training SOP: It describes both regulatory and protocol-specific requirements for training staff prior to them being assigned a study.
- Internal Assessment SOP: It describes the process of carrying out internal assessments of specific studies.
- Inspection Readiness SOP: It states the specifics for adequate preparation in case of regulatory inspection.
QMS For Decision Making in Clinical Research
A QMS plays a crucial role in aiding systematic, precise, and standardized decision-making. It is important to eliminate subjective as well as indiscriminate decision-making and base decisions on real data, tangible certainty, and sound judgment.
Quality management in research is typically driven by the industry (CROs, sponsors, and regulators) in a bid to systematically standardize quality across the clinical development activities’ lifecycle.
All stakeholders including physicians, research participants, sites, and site managers need to be conscious of data-driven results in order to make personalized decisions based on their own requirements and goals.
Other Benefits of QMS
QMS implementation should be a standard practice at clinical research labs as its benefits far outweigh its apparent cost. It has a host of other benefits to the sites, patients, as well as sponsors. Some of these benefits are:
- Quality improvement, which ensures data integrity and minimal delays so that drugs reach the market more quickly.
- The sites have a decreased burden brought about by streamlining the processes of clinical trials as well as focusing on eliminating the “pertinent issues”.
- A QMS aids risk management by identifying loopholes well ahead of time and enables labs to survive third-party audits.
- Increased patient data security in the process of clinical trials.
- It aids the sponsors to resolve repetitive issues that affect the quality and result in higher costs.
Choosing a QMS For Your Clinical Research Facility
Looking for an appropriate QMS for your clinical research facility can be quite a daunting task. Here are some pointers you should look out for.
A QMS should be:
- Cloud-based for data accessibility, 24×7, from anywhere
- Interfaceable with other systems for data interoperability
- Compliant with regulatory requirements
- Capable of document control/management
- Compatible with complaint management systems
- Capable of managing correct and preventive actions (CAPA)
The bottom line is that a clinical research facility should have a quality management system that meets its unique needs as the operations of each vary widely from the other. It should also be adapted to meet quality management requirements, both present and future.
QMS Versus LIMS
While a LIMS and a QMS have a number of similarities, however, they are not the same. A clinical research facility needs to determine if they will need one or the other, or both.
A laboratory software for clinical research labs, also known as a Clinical Laboratory Information Management System (LIMS), is an intuitive solution that enables labs to go paperless by digitally managing data and automating processes.
A QMS, on the other hand, helps labs meet their set standards for quality and hence improves overall productivity.
A full-featured laboratory software for clinical research labs can be optimized to carry out quality functions. In other words, a LIMS can double up as the QMS for a clinical research facility. This will not only save on capital costs but will also boost efficiency and productivity by streamlining all lab operations into one software.
Currently, industry guidance for the quality of clinical research happens to be fragmented across several documents from multiple sources. Though quality systems are present in other industries like pharmaceutical manufacturing as well as aviation, an industry-wide conceptual framework is lacking for clinical quality management which aims at addressing quality as well as monitoring the improvement of performance in complex “clinical development-specific” environments.
By way of partnerships between Health Authorities as well as other industry stakeholders, a QMS has come a long way in improving quality across the clinical research industry, and we can only hope for even more improvements in the future.