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European Pharmaceutical Contractor

Best of Both Worlds

The worlds of clinical and quality share a 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 organisations overlook 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 learn 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 objectives to meet customer requirements. In a nutshell, it is the organisational structure, documents, policies, procedures, processes and resources needed to implement quality management.

These systems are most commonly used in the manufacturing 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 to the management of audits, suppliers/ vendors, electronic batch records, standard operating procedures (SOPs) or other quality-related processes.

The main objectives a QMS is intended to fulfil 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 formalising the steps that should be taken in order to respond to various events (for example, issue management, deviation management, or corrective and preventive actions)
  • To cover the auditing aspect of business processes (like 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 analyse outcomes, trends and actionable events
FDA on Quality Management

In 2012, a biophysicist from the FDA’s Office of Good Clinical Practice (GCP) – named Jean Toth-Allen – hosted a presentation titled ‘Building quality into clinical trials: An FDA perspective’, in which he discussed various ways the Agency 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 the quality manufacturing world is already doing. To name a few examples:

Qualified Investigators
When selecting a site and an investigator for your study, quality and risk mitigation can be achieved by filtering which investigators are specialised 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 trial has its nuance: those variances that make certain aspects of a study unique, but also involve a higher degree of risk. This can be mitigated by highlighting those nuances – the highrisk areas – in study training. In the quality management world, QMS solutions are used to disseminate exams and tests for training purposes in order to emphasise certain aspects of the materials where more focus is needed (like areas of risk).

Adequate Monitoring
Because, as previously noted, the nuances of a study are often the higher areas of risk, the FDA issued a guidance in 2013 called “Oversight of clinical investigations: A riskbased approach to monitoring”. Essentially, these guidelines state that organisations should spend 80% of monitoring time/ resources on the 20% area of higher risk. This seems to indicate that the cookiecutter ‘box ticking’ method of monitoring every single aspect of a site is not an efficient use of time – areas of greater risk demand more attention. In the quality world, QMS users typically have some type of customisable electronic form for similar purposes. Bringing this type of personalised monitoring form into the clinical world would allow for more focus on areas of risk in monitoring visits.

Embedding Quality into Clinical


Following the FDA’s lead, how do you go about embedding quality into every step? You start by recognising that quality does not end at clinical quality. It does not end with writing SOPs on clinical activities; neither does it end when you finish training users on procedures. But a standard QMS leaves gaps that can only be filled by a holistic, integrated system. Having two separate processes for clinical quality assurance and clinical operations creates silos and inoperability, which 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:
  • Improved access to data – getting the right data into the right hands at the right time
  • Increased focus on training that allows for 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
A complete CQMS can breathe new life into a 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.

Risk Mitigation versus Management


We all do our best to alleviate risk each day by making decisions that will improve our chances of a positive outcome. The same approach should be taken in clinical trials, as increased complexity comes with increased levels of risk. Some ways companies may choose to mitigate risk can include:
  • Role-based training: designing custom GCP and protocol training based on users’ roles (such as clinical research associate, monitor) to highlight areas most critical to those functions
  • Vendor qualification: electing clinical partners (like CROs) best qualified to support your clinical studies, considering aspects such as geographic location, therapeutic areas, study aspects and other elements that one vendor may be better qualified to support than another
  • Site qualification: like selecting a vendor, choosing the best sites to enrol in a study can include not only their qualifications, but also past experience and history based on prior monitoring, plus audits of sites
Whenever possible, risk should be mitigated in all aspects of a trial. When this is not possible, those areas should be clearly highlighted and addressed in a risk management plan.

CQMS is not a CTMS


The fear of the clinical and quality world colliding is unfounded. In fact, there is more to be gained by bringing them together. CQMS and CTMS are complementary solutions, and although some overlap may exist between a CQMS and a CTMS (such as monitoring, site management and other areas), a CQMS focuses on aspects of clinical research that a CTMS does not, such as:
  • GCP document management
  • TMF management
  • Training management
  • Protocol deviation management
  • Clinical CAPA management
  • Audit management – study, vendor, sites and so forth
  • Vendor management
In summary, a holistic CQMS can, and should, bring together all of the quality and risk management efforts managed by both clinical quality and operations under a single research organisation. Doing so will lead to a reduction of silos and increased transparency, which, in turn, will result in greater quality and efficiency and reduced duplication of efforts across clinical research. There is nothing to fear when clinical and quality worlds collide.

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Patricia Santos-Serrao is a life sciences professional with almost two decades of experience in regulatory affairs and clinical areas of the pharma industry. She is Market Segment Manager at MasterControl, and has previously held the position of Manager at QUMAS. Patricia earned a Bachelor of Science degree in Business Administration from Western Connecticut State University and University of Phoenix, US.
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Patricia Santos-Serrao
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