Opinion: Exploring the Concept of Quality Management for Clinical Research Sites

Opinion: Exploring the Concept of Quality Management for Clinical Research Sites

A Quality Management System (QMS) is a formalised system that documents strategies processes, procedures, and responsibilities for achieving quality policies and objectives. Furthermore, quality management in the clinical research setting can often be defined as compliance with requirements of the trial process and the credibility and reliability of the data obtained. One can find significant amounts of information pertaining specifically to quality in clinical research, examinations of initiatives into improving clinical development, industrial QMS’s and the concepts and principles that underpin research Quality Management in general.

But what is Quality Management for a clinical research site? What if we want to explore matters other than deviations or data entry or protocol management, but rather, to examine the core systems that run your enterprise, whether it is very small, new, multicentre, hospital-based and so on? There are numerous conjoint Quality Management considerations for sites exclusive of clinical trial conduct alone. With this in mind, what would a conceptual QMS framework for site management even look like? Do either theoretical or clearly defined QMS principles exist for sites?

This is information you simply won’t find and is a stark reminder that within the Quality Management environment, as an industrial stakeholder, sites are generally behind the mark. This represents a problem but more importantly highlights an opportunity.

To begin examination of this opportunity, let us first consider what a QMS actually is at a business level. To make things easier, let’s take out the word Quality and focus only on the Management System aspects. Quality itself is an inherent essential of any research service, not an added bonus, nor extra inclusion. Although quality may at times define the characteristics of your service delivery, you are employing a management system, or more specifically, systems to operate and develop your research site. Site managers may administer these diverse management system methodologies typically varying in degrees of both scope and effectiveness, mainly as a function of the constant and fluid process of actual site management – there is no end, only change, adaption, and continuously complementary processes.

Traditionally, quality management in research is driven by industry (Sponsors and CRO’s) and regulators in an effort to systematically manage quality across the lifecycle of clinical development activities. This can at times be narrowly focused on efficiency of service delivery (start up, site qualification, therapy to market) as the primary assessment measure of QM performance, which although is definitely related to site QM, we must understand that there remain many strategic business outcomes and quality measures that are unique to sites and are independent of undertaking a clinical trial. To be able to qualify these measures that can engender or further inform the development and implementation of a framework for a site management QMS, an introspective approach within the site landscape is required.

Sites, physicians and site managers as a stakeholder group need to be conscious of just waiting for the industry or others to give you what you want or dictate what your own business performance indicators are. The most compelling and appropriate QMS will always be the one that is unique to your individual site’s needs, not the one adapted from someone else. An external QMS framework or initiative created by anyone else outside your organisation will always be more an interpretation of their own company’s requirements or of the actual developer themselves, rather than the actual QMS framework. Furthermore, this essentially creates a second-hand view of a QMS made third hand by your own interpretation of that system. So, begin to teach yourself to ask the right questions specific to your circumstances and don’t depend on others to do it for you; proactivity is the essence of a QMS.

Initial development and ongoing maintenance can honestly be onerous and at times mundane but the effects of a legitimate and productive QMS can be profound for both business and reputation. Once continuous improvement systems are accepted as standard at your site, proactive identification of key business development criteria becomes realisable and actionable. It may not be within the next day or the next study, but it will get easier over time and then objective benchmarking becomes possible. Really, the ultimate point is that site management develops into a systematised organisation of specific knowledge based simply on the principles of cause and effect and applying validated understanding to the next decision being made. Sites today are presented with a worthwhile opportunity to create a standardised QMS that defines site management and operation best practice while accumulating knowledge and evidence to support such initiatives.

The whole idea of a QMS is to make business decisions systematic, precise and standardised. You want to be able to eliminate subjective or indiscriminate decision making related to almost any decision you make. When you say yes, it is based on real evidence, sound judgement and tangible certainty. When you say no, it is because you cannot jeopardise your standards or business management objectives. It’s a system – one that represents a scalable and reproducible site quality management methodology that has many benefits once it becomes standard practice at site.

Firstly, an effective QMS significantly helps reduce the burden of stress that usually accompanies any new problem or challenge at sites (e.g. recruitment, contracts negotiation, budgeting, etc) because each of these issues are actually viewed as a necessary, constructive process – it’s less intimidating. Secondly, it contextualises such site management issues because you immediately start thinking about the effects and potential responses to each concern – they can be broken down and analysed easier. Thirdly, it encourages business growth – a QM mentality forces you to adapt and improve on a constantly recurring basis. And lastly, it’s self-perpetuating. Every problem you view or solve this way makes future problems easier to handle, forming a positive cycle of reinforcement.

The added value of having a QMS at a research site is also predominantly based on managing different types of risk that encompass the activities that are most closely aligned to your current or emerging business. The overall (QMS) must consider both risks and opportunities as part of core planning and site managers must promote risk-based thinking. This enables risks and opportunities that affect stakeholders to be identified ahead of time and managed appropriately.

The first type of risk is based on Opportunity. This type of risk comes from basically taking one opportunity over potential others. Examples of this could include launching new services or expanding your research business geographically or into new markets. Opportunity-based risks for a research business may also include:

  • Choosing to do certain studies;
  • Choosing to conduct studies for specific indications;
  • Agreeing to certain CTA terms;
  • Using a certain recruitment method;
  • Choosing a which CTMS to use;
  • Joining a research network.

When managing risks associated with opportunities, a site manager needs to consider the potential advantages and disadvantages of an opportunity, including the type, the magnitude and the likelihood of them occurring and the investment required to position your site to optimally take advantage of these opportunity risks. By deciding to commit your resources to one opportunity, you risk:

  • Missing a better opportunity;
  • Getting unexpected results.

The second risk is based on Uncertainty. This type of risk comes from uncertainty around unknown or unexpected events. It’s hard to predict these events and the damage they can cause. It’s also hard to control the damage once these events occur. For example:

  • Damage by fire, flood or disasters;
  • Unexpected financial loss due to a poorly performed study;
  • Significant unpaid debtors from clients that owe you money;
  • Loss of important suppliers or customers;
  • Cancellation of studies;
  • Decrease in trial opportunity share because competitors or products enter the market;
  • Litigation;
  • Equipment failure.

The last is Hazard-based Risk. These types of risks come from dangerous situations in the workplace and are largely related to issues of WHS.

So, we can see that importantly, risk-based thinking informs business QMS processes which ultimately turns decision making into a systematic process that is free from certain subjectivity. You want to be able to get to a point of study bargaining where it almost doesn’t matter what the protocol requires. For example, you can determine what your cost-benefit or financial break-even points are simply by calculating the per patient fee divided by number of visits, add variables and your overhead and then specific negotiation becomes secondary to plain fact. Proactive financial quality management in clinical trials means considering protocol requirements and budgets items ranging from the minimum feasible to the perfectly ideal. The minimum feasible outcome within the clinical trial quantifies priorities that are indispensable to fulfilling the protocol within a specific time frame and whether your site can cover its fixed or operational costs during that period. These indispensable priorities and fixed operational costs represent the minimum trial budget goal.

If, as a site, you have followed specific processes, used standard fees, and spent the time to calculate the operational costs per week, per month and per study, feasibilities and budgets that come to your site are either acceptable or completely unacceptable based on your institution’s policies and objectives and no one else’s. Despite what other sites or CRO’s or Sponsors may dictate, you’ll know what you are doing is the most responsible business action based on reliable strategic financial planning and sound administration that has been documented and experienced over time that no one else can ever really know.

We must remember that the professional and responsible conduct of a clinical trial alone does not define a site-based quality management system. The responsible conduct of a clinical trial is only a by-product of well-trained staff, in a well-managed facility, within a sustainable company that has appropriate strategic direction and is governed by well written policies, procedures and instructions – a management system. A clinical trial is the end result, not the beginning.


Dom Bailey