In a classic episode of Seinfeld, George Costanza is terrified of the potential ramifications of his “worlds colliding” when his fiancée, Susan, becomes friendlier with his dubious pals Elaine, Kramer and Jerry. “Everybody knows you’ve got to keep your worlds apart,” George rants (but when does George not rant?) “If Susan is allowed to infiltrate this world then George Costanza as you know him ceases to exist. If Relationship George walks through this door, he will kill Independent George! A George divided against itself cannot stand!”
| Organizations overlook benefits that
can be achieved by applying the same tools
and methods in the clinical space that they
are already using for quality management.
The worlds of clinical and quality share the same collision anxiety. Many companies mistakenly believe that quality and clinical are completely separate departments that should maintain their data and processes in discrete silos. What these organizations are overlooking are the benefits that can be achieved by applying the same tools and methods in the clinical space that they are already using for quality management.
What is a QMS?
To understand how quality management strategies can be beneficial in clinical settings one must first understand what a quality management system (QMS) is and what it does. A QMS is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements. In a nutshell, it is the organizational structure, documents, policies, procedures, processes and resources needed to implement quality management. These systems are most commonly used in the manufacturing business areas to manage quality of product output. The average electronic QMS on the market today includes software solutions for managing documents, training, quality events and analytics. Some electronic QMS products also feature modules specifically tailored for the management of audits, suppliers/vendors, electronic batch records, standard operating procedures (SOPs), or other quality-related processes.
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The main objectives a QMS is intended to fulfill are:
- To document SOPs for roles and activities.
- To ensure adequate and proper training of personnel participating in activities.
- To establish methods of managing processes and formalizing the steps that should be taken in order to respond to various events (i.e., issue management, deviation management, and corrective and preventive actions).
- To cover the auditing aspect of business processes (i.e., knowing that what must be done is actually being done and being adequately prepared to manage events when they arise). To ensure partners and suppliers meet acceptable levels of quality.
- To analyze outcomes, trends and actionable events.
What is the FDA’s perspective on quality management and how does it fit into clinical?
In 2012 a biophysicist from the FDA’s Office of Good Clinical Practice named Jean Toth-Allen hosted a presentation titled “Building Quality into Clinical Trials – An FDA Perspective” in which he discussed various ways the FDA is encouraging companies to “embed quality practices” into the clinical trial process. The enlightening presentation connected the dots between what the clinical world should be doing and what quality manufacturing world is doing already. For example:
- Qualified investigators: When selecting a site and an investigator for your trial, quality and risk mitigation can be done by filtering which investigators are specialized in the given area, which doctors and hospitals have the staff to support a trial in that area, and which sites are best equipped to support the variances of the particular study. Just as a QMS is used to qualify which manufacturer’s suppliers are approved for some parts but not others, that same component could be applied to determine which sites are qualified to do some types of studies and not others.
- Adequate training: In the clinical world, each study has its nuance, those variances that make certain aspects of a study unique but also involve a higher degree of risk. Risk can be mitigated by highlighting those nuances—the high-risk areas—in study training. In the quality management world, QMS solutions are used to disseminate exams and tests for training purposes in order to highlight certain aspects of the materials where more focus is needed (i.e., areas of risk).
- Adequate monitoring: Because, as previously noted, the nuances of a study are often the higher areas of risk, the FDA in 2013 issued the guidance “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring”. Essentially, the guidance states that organizations should spend 80 percent of monitoring time/resources focusing on the 20 percent area of higher risk. This seems to indicate that the cookie-cutter “box ticking” method of monitoring every single aspect of a site is not an efficient use of time—areas of greater risk demand more focus. In the quality world, QMS users typically have some type of customizable electronic form for similar purposes. Bringing this type of “customized” monitoring form into the clinical world would allow for more focus on areas of risk in monitoring visits.
Embedding quality into clinical
So, if you’re going follow the FDA’s lead, how do you go about embedding quality into every step? You start by recognizing that quality does not end at clinical quality. It doesn’t end with writing SOPs on clinical activities. It doesn’t end when you finish training users on procedures. But a standard QMS leaves gaps that only can be filled by a holistic, integrated system. Having two separate systems for clinical QA and clinical operations creates silos and inoperability that impedes the ability to embed cross-functional best practices across clinical research.
The solution is a clinical quality management system (CQMS) that truly brings clinical operations and clinical quality together. A complete CQMS approach provides three distinct and powerful benefits:
A complete CQMS can breathe new life into your worn-out clinical trial management system (CTMS) by providing a multitude of benefits, such as: increased data integrity; better deviation prevention; improved risk mitigation; more control over corrective actions; reduced costs; and streamlined operations.
- Improved access to data—getting the right data in the right hands at the right time
- Increased focus on training that allows you to take knowledgeable, informed actions
- The application of corrective and preventive action (CAPA) techniques to clinical operations, which helps study managers mitigate risk and cope with exceptions more effectively
Risk mitigation vs. risk management
We all do our best to mitigate risk each day by making decisions that will improve our chances of a positive outcome. The same approach should be taken to mitigate risk in clinical trials. With increased complexity in clinical trials, comes increased level of risk. Some ways companies may choose to mitigate risk can include:
Whenever possible, risk should be mitigated in all aspects of a trial. When mitigation is not possible, those aspects should be clearly highlighted and addressed in a risk management plan.
- Role-based training: Designing custom GCP and protocol training based on users’ roles (i.e., CRA, monitor) to highlight areas most critical to those roles.
- Vendor Qualification: Selecting clinical partners (i.e., CROs) best qualified to support your clinical studies, factoring aspects such as geographic location, therapeutic areas, study aspects and other areas that one vendor may be better qualified to support than another.
- Site Qualification: Like selecting a vendor, selecting the best sites to enroll in a study can include not only their qualifications but also past experience and history based on past monitoring and audits of sites.
Components of clinical quality management (and examples of each)
Organizations looking to implement an electronic clinical quality management system (CQMS) should use the following list to consider the thoroughness of a solution. A holistic CQMS should include:
- Document Management: For the management of clinical quality (i.e., GCP SOPs) as well as clinical operations (i.e., Trial Master File [TMF]) documentation
- Training Management: For the management of training activities, preferably integrated to utilize GCP documents as materials to easily configure role-based training
- Quality Event Management: For the management of quality process templates designed for quality activities such as site monitoring, protocol deviation management, issue management and clinical CAPA
- Audit Management: For the management of various types of audits executed through a clinical trial on GCP compliance, studies, vendor and sites
- Vendor Management: For the management of information and ongoing relationship between sponsors and clinical vendors (i.e., CROs)
- Site Management: For the management of information and ongoing relationship between study sponsor and clinical study sites
- Reporting and Analytic: A holistic integrated CQMS provides greater transparency, tracking and trending and a through reporting and analytical component provides real-time information for essential critical business decisions
CQMS is not a CTMS
The fear of the clinical world and the quality world colliding is unfounded. In fact, there is more to be gained by bringing the worlds together. CQMS and CTMS are complementary solutions. Although some overlap may exist between a CQMS and a CTMS (such as monitoring, site management and other aspects), a CQMS focuses on aspects of clinical research that a CTMS does not, such as:
In summary, a holistic Clinical Quality Management System (CQMS) can and should bring together all of the quality management and risk management efforts managed by both clinical quality and clinical operations under a single clinical research organization. Doing so will lead to a reduction of silos and increased transparency, which will lead to greater quality and efficiency and reduced duplication of efforts across clinical research. There’s nothing to fear when clinical and quality worlds collide!
- GCP document management
- TMF management
- Training management
- Protocol deviation management
- Clinical CAPA management
- Audit management – study, vendor, sites, etc.
- Vendor management
This article is taken from European Pharmaceutical Contractor August 2016, pages 20-22. © Samedan Ltd.
Patricia Santos-Serrao is a life sciences professional with almost two decades of experience in regulatory affairs and clinical areas of the pharmaceutical industry. She is currently MasterControl's market segment manager, global pharmaceutical, blood & biologics.
Prior to joining MasterControl, Patricia held the position of manager, global regulatory safety for QUMAS, a company specializing in quality and compliance management software for life sciences, where she helped drive the development, sales, marketing and implementation of solutions for the R&D areas of the pharmaceutical industry with a particular focus on submission document management for regulatory affairs and clinical trial master files (CTMF) for clinical.
She's worked for several Tier 1 pharmaceutical companies, including Schering-Plough and Boehringer Ingelheim, both in regulatory affairs and clinical. She has assisted various pharmaceutical, biotechnology and medical device companies in implementing electronic document management and submission solutions, and in compiling electronic common technical documents (eCTDs) and other submission format filings worldwide.
A graduate of Western Connecticut State University and University of Phoenix, Patricia holds a Bachelor of Science degree in Business Administration. Patricia is a member of the Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA). She has also earned her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Regulatory Affairs Certification Board (RACB).