When a life-sciences organization has an effective quality management system (QMS) in place, it is demonstrating to its end-users and the regulatory agencies that its products/services are of the highest industry standards.
Similarly, when the sponsor of a clinical trial (e.g., a pharmaceutical, medical devices, biotechnology) company or a clinical research organization (CRO) has a holistic quality management system, namely, a clinical quality management system (CQMS), it will help assure that the trial participants, health agencies, regulatory agencies, and stakeholders that the clinical research is of the highest standards. The CQMS will benefit CROs to find out whether a new treatment, such as a new drug, diet, or medical device is safe and efficacious.
Considering that clinical research is complex and time-sensitive wherein clinical trial processes may last several years to conduct, a delay of even a few days because of quality events will not only add to your costs but also, will give your competitors the chance to catch up. When you have an effective CQMS in place, you will not be giving such a chance to a competitor CRO or sponsor.
However, it can be quite challenging to implement a CQMS because its components are not well-structured and different regulators may have different requirements. There are no guidelines for a holistic CQMS yet.
In this article, we will cover the needed elements that will help you achieve a holistic clinical quality management system. We will also highlight the value of QMS software solutions that will help you in the implementation of an effective clinical quality management system.
But first, let’s start with the basics:
- What Is a Clinical Quality Management System?
- What Are the Benefits of a Clinical Quality Management System?
- What Are the Regulatory Requirements for a CQMS?
- Clinical Quality Management System Framework
- The Role of Digital Clinical Quality Management Systems
- Frequently Asked Questions About Clinical QMS
What Is a Clinical Quality Management System?
A clinical quality management system (CQMS) is a quality management system that is specific for clinical research.
With the assistance of a CQMS, your organization (for example pharmaceutical, biotechnology, medical devices company, healthcare institution sponsoring clinical trials, or the clinical research organization conducting such clinical trials) will be able to implement the applicable regulatory standards, concepts, and methodologies needed to achieve the goals of clinical research.
When you have an effective and efficient clinical quality management system in your organization, you will enhance the management of all protocols, processes, documents, and audits that take place during the entirety of the clinical trial.
You will be improving your organization’s efficiency, enhancing risk management practices, advancing risk mitigation, and accelerating the set goals, which is to find out whether a new drug, treatment, medical device, or diet is safe and efficacious.
Let us say that you are a pharmaceutical company conducting a clinical trial to test the efficacy of a combination of cabotegravir and rilpivirine for the treatment of HIV/AIDS. A competitor pharmaceutical company is also testing the same combination. Because of the efficient CQMS in place, the clinical trial that you conduct is accurate and there are no hassles. Your competitor is beset with problems because of the poor CQMS they have. Your organization is the first to apply for a new drug application (NDA) to the US FDA.
With a proficient QMS software solution such as SimplerQMS in your organization, you are assured of cloud-based integrated QMS software that has enhanced capabilities that will help you in implementing a holistic clinical quality management system.
Such QMS software solution will also help you streamline all the required processes and become compliant with current applicable international regulatory requirements such as Good Clinical Practices (GCP), the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA), and others.
What Are the Benefits of a Clinical Quality Management System?
When you have a clinical quality management system that is personalized to the requirements of your organization, you will accrue many benefits.
The main ones are the following:
- Patient and consumer safety: This is assured by the generation of reliable data that your organization, your partners, regulatory and healthcare authorities, and other stakeholders can use for improving the lives of patients. Also, you guarantee clinical trial participants that the generated data will be used solely for the advancement of scientific knowledge. Furthermore, the end-users of the results of clinical research are assured that the medications/treatments that they receive are based on proper research.
- Regulatory compliance: You will be able to methodically and universally manage quality through the entirety of clinical research. This will range from first-in-human trials to post-marketing studies. This also means that you will assure compliance with all the applicable regulatory requirements.
- Quality assurance: You will reduce or eliminate repetitive quality issues such as intentional/unintentional non-compliance, insufficient staff training, reduction in resources, insufficient supervision by management, lack of protocol clarity, and insufficient quality control in the collection and recording of data. All of which threaten patient safety/data integrity.
- Holistic approach: The CQMS will support your organization to systematically and holistically manage quality across the entire gamut of activities. By this, you can achieve both the objectives of the organization and the clinical research you are conducting.
- Proactiveness: An organization involved in clinical research may be dealing with issues reactively. Rather, with an up-to-date, systematic, and holistic CQMS, you will be able to eliminate/reduce errors before they arise. By being proactive, you can avoid wasting time and precious resources.
What Are the Regulatory Requirements for a CQMS?
The main regulatory requirements that your organization will face when conducting clinical research include:
- ICH E6 (R2) Good Clinical Practice
- ISO 14155:2020
- Regulation (EU) No 536/2014
Let’s look at them in more detail.
ICH E6 (R2) Good Clinical Practice
The document describing ICH E6 (R2) Good Clinical Practices states:
“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 is an international quality standard, which governments can translate into regulations about how to manage clinical investigations of medical devices for human subjects.
ISO 14155:2020 is described as, the following:
“This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
This document 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.”
However, the document does not apply to in vitro diagnostic medical devices.
Although ISO 14155:2020 and ICH E6 (R2) have some overlap, ICH E6 (R2) is focused on pharmaceutical companies, while ISO 14155:2020 standard is focused on medical device companies.
European Medicines Agency Clinical Trials Regulation (Regulation (EU) No 536/2014)
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.”
To put it concisely, an organization conducting clinical research must comply with good clinical practice in the design, conduct, recording, and reporting of all clinical trials where human participants are involved. By complying with this standard, you are assuring both the public and the regulatory agencies.
Clinical Quality Management System Framework
ICH E6 (R2), ISO 14155:2020, and Regulation (EU) No 536/2014 show that the guidance that you will need to conform while doing clinical research can be diverse, across multiple documents and multiple agencies.
As per the guidelines put forth by the FDA and other regulatory authorities, the requirements that are pertinent to the manufacture of drugs and medical devices will also be applied to clinical research, right from the initial stages of an investigational to a marketed product.
This means that the quality management system that your life-sciences organization has developed to oversee clinical operations is a clinical quality management system.
The non-profit organization, TransCelerate BioPharma Inc., partnered with various national health authorities and other industry stakeholders to explore ways and means to improve and streamline quality across the clinical research industry. This initiative resulted in the Clinical QMS Conceptual Framework. The analytical report detailing this project was published in the Develop Innovate Advance (DIA) Journal, Therapeutic Innovation, and Regulatory Sciences, in 2016.
The paper TransCelerate’s Clinical Quality Management System: From a Vision to a Conceptual Framework highlights the foundational aspects and core elements of a clinical QMS Framework that is relevant to all organizations in the field of clinical research.
In the following sections, we will take a deeper look at each foundational aspect and core element that is essential for a holistic CQMS. You will also better understand how a QMS software, like SimplerQMS, can help your organization streamline the entire QMS process.
The underpinning aspects are as follows:
- Understand the concept
- Leadership commitment to quality
- Organizational commitment to quality
- Continuous improvement
Understand the Concept
As mentioned previously, when you are a sponsor of a clinical trial or a clinical research organization involved in clinical research and trying to find out a new drug, vaccine, treatment, diet, or medical device that is safe and effective for humans, you must have a CQMS in place.
For this to happen, you will need to, first of all, appraise and appreciate the milieu (both external and internal) in which this CQMS needs to work.
The external milieu to be taken into consideration will include the environment (political, legal, technological, economic, and social) in which your organization is operating. This also includes the applicable laws and global regulatory authority regulations and your external stakeholders.
The internal milieu includes your organizational structure, internal stakeholders, and the information you have gathered from previous development programs.
Leadership Commitment to Quality
You will need to define the quality that you expect from your employees.
The message of quality will be tangible, trustworthy, and consistent, such that employees at all levels within your organization will support and follow it.
For example, in a medical devices company, the quality policy which is written by the senior management will highlight the overall goals of the company. The quality policy will direct employees at all levels of the hierarchy to create and deliver top-quality medical devices to the end-users.
Organizational Commitment to Quality
When the senior leadership has taken the onus of quality, the entire organization will become accountable.
All employees must have equal opportunities to talk about quality, raise concerns, and be proactive.
The clinical QMS is dynamic and tailor-made for your organization. You will proactively enhance both the efficacy and efficiency of the CQMS.
This is possible via self-assessments, internal audits, and feedback from employees.
With an eQMS software like SimplerQMS, you are provided with unique features like automated assigning of tasks and reminders, electronic signatures, and much more. This will put the onus on each individual within the organization to take ownership of quality irrespective of their role and to hold not only themselves but also others, accountable for quality.
An added advantage of the SimplerQMS QMS software solution is that it promotes constant quality improvement. This is made possible by automating change control tasks, and automatic tracking of changes in instructions, SOPs, product processes, and products. All these changes are sent through an automated approval process.
The Core Elements of a Clinical QMS Framework
The core elements include processes:
- Roles and responsibilities
- Risk management
- Issue management
- Knowledge management
- Documentation supporting the achievement of quality
You must clearly define and characterize the course of action and then determine which of these need supporting procedural documentation.
The procedural documents are fit-for-purpose. They include policies, SOPs, and work instructions. These documents are concise, clear, and may be cross-disciplinary. These documents will also highlight the role of leadership in quality.
Procedural documents will help your employees identify their roles and responsibilities. You will also need to streamline the training of staff on these procedural documents.
SimplerQMS makes your tasks as a Quality Assurance specialist so much easier by providing a centralized cloud-based repository for all your SOPS, documents, and policies. This makes it easy for relevant staff to search and retrieve them when required. This is particularly useful during audits and inspections when you need to retrieve current documents as required by the inspectors.
Recommended Reading: SOP Management in Pharmaceutical Industry
Resources, Roles, and Responsibilities
For achieving the goals of clinical research, you will need to appraise what resources and skillsets are needed.
Senior leadership will guarantee the availability of staff and material resources like systems, standards, and training facilities.
Throughout the organizational hierarchy, you will clarify the roles and responsibilities of each and every member. Additionally, all members, be they permanent or temporary staff/contractors, will need to be suitably trained. They will also need to have sufficient experience in the performance of the tasks they are assigned.
Electronic QMS like SimplerQMS helps you in the implementation of organization-level quality principles. It connects managers to their respective protocols, procedures, records, and documents. These include work instructions, SOPs, and training certificates.
You will be able to easily and efficiently send documents via automated workflows for review and approval based on user roles and responsibilities using SimplerQMS.
Irrespective of the partnerships you have in the setting of clinical research, all parties need to take ownership of their role in quality.
You will ensure that each party has their tasks/activities laid out. Also, it must be made clear about the expectations, key performance indicators, and risks involved in such a partnership.
The SimplerQMS supplier management software module will help you automate your vendor selection process. The system does this by allowing you to evaluate and qualify each vendor against a set of performance criteria.
The software will maintain a list of approved suppliers. It also provides forms for record keeping of all contracts, surveys, certificates, and supplier evaluations.
Additionally, the SimplerQMS software will notify the relevant persons at the appropriate time when a vendor needs to be re-qualified.
Recommended Reading: The Simple Guide to Supplier Qualification in Life Sciences
Risk management means that your organization will take into account all possible uncertainties before achieving both organizational and quality objectives.
Such risk management needs to be integrated into your day-to-day decision-making, and its value must be communicated to all levels of the organization.
With the SimplerQMS software solution, you can easily manage your organization’s risk files by connecting risk management documentation with your equipment, components, products, customers, and suppliers. Throughout the lifecycle of a product, the software allows you to link risk management documents and assignments as risk control actions and design controls to reduce risk.
You will be able to get a clear overview of your current risk documentation and get an accurate representation of all risks across processes and products. You can then take corrective action to mitigate them.
With an effectual issue management framework in the CQMS, you can enhance the identification, communication, escalation, and investigation and assessment of important issues that can impact patient safety, data integrity, or trust in your organization.
QMS software solution with built-in issue management capabilities automatically notifies the concerned staff when quality issue tasks are assigned to them. As a result, the software helps you quickly and easily generate CAPAs and track their progress.
Additionally, you will be able to monitor incomplete and overdue CAPAs and review quality issues by data points such as product, processes, components, equipment, customers, and suppliers, using customizable dashboards.
You will also need a knowledge management framework for the successful implementation of a CQMS.
The goal is to get the correct information to the correct people at the correct time. When knowledge is lost or you fail to apply it, there can be negative and disastrous consequences for you and your patients.
Let’s imagine the following – because of staff insufficiency, a new clinical research associate (CRA) has been put in charge of a clinical trial study center. This CRA hasn’t yet completed training. The consequences can potentially be disastrous for your trial participants and your organization.
The SimplerQMS software solution has robust training management capabilities that will help you automate all your training activities. It can contain all your employee records and allows you to efficiently handle all functions from planning the training sessions to executing them.
It automatically sends notifications when new training material is released. At the end of the training sessions, it generates relevant certificates with electronic signatures.
Documentation Supporting Achievement of Quality
Since you are involved in clinical development, you will understand that the level of documentation needed is proportionate to the significance of the activity and the risks involved.
Before documentation, you need to establish how, duration, and where the documentation needs to be retained.
SimplerQMS software solution is the automated document control software that enables your organization to automatically generate documents in the approved formats with all the required approvals. It also ensures that the staff can only access the correct and updated versions.
SimplerQMS provides you with ready access to documents stored in a centralized file repository. You are saved the trouble of manual record-keeping in all the critical departments of your organization.
Recommended Reading: What is Document Control in Life Sciences?
Management Review and Assessment of the Clinical QMS
Lastly, you will assess the overall condition and efficacy of the CQMS via management reviews and assessment of the CQMS.
Assessment of the Clinical QMS
You will assess the core elements of the CQMS individually and collectively.
Not only should a baseline assessment be conducted, but periodic evaluations are needed as part of continuous improvement.
The inputs you gather from these assessments will be helpful during the management review.
Your organization will need senior management with the necessary authority to review the CQMS regularly.
This will ensure that the CQMS is fulfilling the quality objectives of your company and that the benefits accrued are worthwhile.
With SimplerQMS you will get real-time dashboards and KPI reports that are timely and beneficial for your management review meetings. With these inputs, the senior management will be able to assess the quality of the products and quality process performances during the lifecycle of any given product.
The Role of Digital Clinical Quality Management Systems
When you are conducting a clinical trial, you will realize that from the day you start the pre-trial planning to the completion of the trial, the challenges can be overwhelming. In addition to the actual research involved, you are also faced with a huge amount of documentation, including investigator’s brochures, clinical study protocols, case report forms, study reports, informed consent forms, trial master files, and much more.
You need to continually monitor the clinical trial sites, staff must be properly trained, and all stakeholders must be compliant with regulatory requirements.
These processes will become extremely difficult if you are using manual paper-based systems with their inherent drawbacks – storage, multiple documents, safety, costs, and environmental impact.
With the SimplerQMS quality management software suite, you are assured of managing both quality and compliance in accordance with applicable life science standards and regulations.
We provide an all-in-one solution, made specifically for life science organizations, that enables you to automatically document all processes and protocols, automate workflows, have full traceability, access from anywhere in the world, save time and resources, and ensure compliance.
The SimplerQMS software solution streamlines clinical QMS by providing you with a holistic and dynamic solution with integration to other quality processes – from document control and training, to issue management and CAPAs, to suppliers and risk management.
Frequently Asked Questions About Clinical QMS
What Is a Quality Management System in Clinical Research?
A quality management system in clinical research is referred to as a clinical quality management system (CQMS). Effective CQMS provides you with an integrated, dynamic, and flexible solution wherein your quality targets are methodically achieved.
Why Is Clinical Quality Management Important?
Clinical quality management is important because of the many benefits associated with it. These include enhancing patient safety during the clinical trial, being compliant with international regulatory standards, lowering costs and time, and being able to accelerate the goals of clinical research, specifically, drug development and delivery.
How Do You Ensure Quality in Clinical Research?
You can ensure quality in clinical research by incorporating an electronic CQMS such as the SimplerQMS software solution. Its key features include automated document workflows, assignments, and reminders for your SOPs, documents, and records.
This helps ensure that studies are conducted according to the protocol and that the data collected is of high quality. Furthermore, you can be sure that every required step is followed to avoid roadblocks during the clinical research process.
With an efficient, dynamic, and adaptable CQMS, your organization will emphatically assure your patients, other stakeholders, and the regulatory agencies that the clinical research/clinical trial that you are conducting is of the highest standards. You will emphasize that the drug, treatment, vaccine, or medical device is safe and efficacious.
Well-structured clinical QMS will also help you reduce errors, time, and costs.
If you are in the process of streamlining your CQMS through the implementation of a QMS software solution or planning to do so, we recommend you book a demo today and talk to our experts at SimplerQMS.
The software has many in-built features that will help you access the market faster and ensure compliance with the applicable regulatory requirements.