Raising Quality Awareness in CROs

August 1, 2012

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-08-01-2012, Volume 21, Issue 8

Quality is not just a way to gratify sponsors or authorities, but should be part an established and dynamic QMS.

Quality is often hard to define and "awareness" according to the Wikipedia definition is a "state or ability to perceive, to feel or to be conscious of..." Unsurprisingly, "quality awareness" can be a relative concept that is difficult to understand and that approach should be aimed at both management and employees within a CRO in order to be effective.

Nicky Dodsworth

Quality starts from the top of the organization which defines the culture, values, and vision through various mission statements, policies, and plans, filtering down to the employee level. Management needs to really engage with building quality and spread the message to their teams. Employees observe and reflect on the messages and actions that come from their managers.

Quality is not just a way to gratify sponsors or regulatory authorities, but should be a part of an established and dynamic quality management system (QMS) and incorporated into everyone's daily activities. It is vitally important to establish, actively improve, and continue to develop policies and processes such as standard operating procedures. Although management may be reluctant to lead the way and provide necessary resources, quality assurance (QA) may need to remind them of the costs involved in loss of reputation and business without quality being inherent in daily activities. Often, quality is seen as costly and a distraction from the main business.

The QA group has a high-profile role within all organizations and should be viewed as partners, reporting to senior management, influencing processes and strategies, and as such their ability to communicate effectively despite all these challenges is at times difficult. QA visibility within the organization, either by local support or using a help desk or just knowing who to go to with questions, encourages reporting of quality problems before they become significant issues. Operational teams should respect the role of quality and respond positively and in a timely manner to QA.

The role of QA has changed over the last few years with more time spent on "virtual auditing" and remote reviews of data which are both cost effective and efficient. The ability to do "more with less" actually translates into more interactions throughout the organization, which further raises the quality profile.

All employees need to be respected, nurtured, work with their management teams in defining processes, and made aware of their contribution and their importance in achieving acceptable quality levels. Only by holding the whole organization accountable for working together to focus on quality improvements and metrics to track various quality steps, can quality awareness can be raised.

Quality should be part of everyone's job by encouraging objectives which look at defining better processes or ways to develop a higher quality product or looking at the amount of positive feedback that is received, rather than negative objectives.

Staff training and performance are important to running a successful quality project. Roles and responsibilities define accountability and need to be carefully defined. A good place to start is with a clearly defined contract so everyone knows their part. CROs need to find the right balance between speed and quality. Quality is a "given" and many contracts have conflicting goals which distract from quality through use of unrealistic recruitment penalty clauses. A true partnership approach is required and responsiveness needs to be bilateral.

Raising quality awareness is not just the role of the QA department but it requires buy-in from everyone.

Nicky Dodsworth Vice President, Global Quality Assurance, Premier Research Group E-mail: Nicky.Dodsworth@premier-research.com

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