ISO 15189:2012: The New Normal

Over the last decade, the U.S. Food and Drug Administration (FDA), and other global regulatory agencies, have been placing increased scrutiny on clinical data quality. It has become clear that the traditional paradigms of sample testing management will not be sufficient in the future.

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In order to avoid putting clinical trial programs at risk, the pharmaceutical industry will need to place a greater emphasis on meeting the new standards for testing data quality and documentation. The need to do so has become more pronounced with the increase in esoteric testing that has been seen in recent clinical trial programs. For example, the rise in genomics testing, immunohistochemistry (IHC) markers and flow cytometry panels has increased the volume of tests being sent out to referral laboratories. The frequency of warning letters from the U.S. FDA has also increased dramatically in the last few years.

Quality Management at the Forefront

This increased regulatory scrutiny has been a stimulus for the development of more effective and consistent quality management systems. Currently, the International Organization for Standardization’s accreditation for medical laboratories, ISO 15189:2012, is quickly becoming the global standard of excellence for medical laboratories, including new quality standards for central laboratories and referral laboratories.

Regulators want assurance that the quality of clinical testing work, regardless of where or by whom it is conducted, is up to appropriate standards, and they are holding both sponsors and CROs accountable. Sponsors are therefore pushing for both the central labs and referral labs they entrust their samples with to conform to ISO 15189:2012 standards and other international standards such as Good Clinical Laboratory Practice Guidelines (GCLP).

Quality Enhancements Driven by Global Standards

The ISO 15189 standard was developed to bring globally consistent standards to the quality management system requirements for medical laboratories. Adherence to this standard is not yet required by the U.S. Food and Drug Administration (FDA) or the College of American Pathologists (CAP). However, the standard is being increasingly recognized worldwide as containing important new quality provisions that, when followed, can minimize the risk of compromising clinical trial outcomes resulting from insufficient quality management and governance.

The latest revision, ISO 15189:2012, introduces specific language concerning the quality management and performance monitoring of external testing run by central laboratories for clinical trials. Simply put, if the data from external testing is placed into the central lab’s database, the central lab becomes responsible for ensuring that the quality management leading to those results meets regulatory standards. This removes a longstanding source of ambiguity in quality accountability, and suggests that a new model for external testing may be needed. While the ISO 15189:2012 standard helps medical labs develop their management systems and assess their own competence, it is also used by customers, regulatory agencies, and accreditation bodies to confirm or recognize the competence of a medical laboratory.

In order to demonstrate our commitment to our Quality Management System and continuous improvement, Covance Central Laboratory Services (CLS) waited until ISO 15189:2012 was clearly defined, and then began preparing for accreditation at our five central labs located in the United States, Switzerland, Singapore, China and Japan.

Sponsors’ Needs Drive  Our Path to Accreditation

We have received frequent inquiries from clinical trial sponsors concerning how our processes and practices align with the ISO 15189 international standard.  Our Quality Management System and procedures have been enhanced to align with the ISO 15189:2012 standard and are preparing our laboratories for accreditation.

In 2010, we began a systematic process of enhancing our Quality Management System to align our processes with the ISO 15189:2012 standard. Accreditation bodies such as CAP are already making appropriate adjustments to accommodate the 2012 standard and will begin providing accreditation this year.

We selected CAP, which is respected worldwide for their commitment to ensuring quality laboratories, as our ISO 15189 accrediting body. CAP has demonstrated an in-depth understanding of the ISO 15189 requirements and is thoroughly familiar with our labs and processes.

Our Geneva, Switzerland lab was the first of our labs to go through the ISO 15189 accreditation process. Europe has led the way toward requiring this accreditation for medical labs and our sponsors with significant European patient populations were specifically asking for it. In October 2013, our Geneva laboratory was assessed for ISO 15189 compliance, and received accreditation shortly afterward. The CAP team performed the audit with full understanding and scrutiny that Covance is pursuing the more stringent ISO 15189:2012 compliance.

In June 2014, we expect our Singapore laboratory to be the first of our labs to be assessed to ISO 15189:2012 requirements. Indianapolis will follow later in the year. We will continue this process until all of our labs are accredited.

The Quality Journey is Easier When It’s Shared

With the increased complexity of trials, heightened regulatory scrutiny and increased globalization of clinical trial testing, pharmaceutical companies need to reduce risk and focus on their core competencies. By choosing the right central lab partner, sponsors can reduce the time they spend overseeing the generation of clinical data that forms the majority of their new drug application, while feeling increasingly confident about the quality of that data. ISO 15189:2012 accreditation is one way we ensure our partners that their technical data will stand up to the higher scrutiny of regulatory agencies.

Covance CLS is committed to delivering the highest possible data quality, through global optimized processes. However, this is not a single event that can ever be completed, rather a journey we will continue to take side by side with our sponsors, enabling them to be more confident in bringing new treatments to market sooner.

High data quality and reduced risk are a continuous journey on the path to revealing new treatment opportunities. With a partner relentlessly focused on exceeding industry expectations for quality, your journey is smoother.  Let’s begin the conversation about transforming your quality journey.

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