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February 2013
By Natascha Kozlowski
One of the main strengths in working with an Academic Research Organization (ARO) is that it combines the scientific and clinical leadership of the academic community with the operational excellence of a Contract Research Organization (CRO). However, there are several myths about AROs that continue to permeate – the most prominent being that AROs are lacking in quality assurance measures for their clinical research.
This misconception may stem from many AROs not having extensive units dedicated specifically to Quality Assurance. This does not translate into a deficit of a research quality system. Academic Research Organizations have reduced functional silos that are typically found in their CRO counterparts. This allows for effective and efficient internal collaborations and processes, including quality assurance.
Like many AROs and CROs, the quality system at the Applied Health Research Centre (AHRC) is guided by regulations, Good Clinical Practice (GCP), and client specifications and expectations. Additionally, Quality is also entrenched in our Research Informatics Platforms, which include Medidata RAVE®, the industry-leading system for capturing, managing and reporting clinical research data. RAVE® is fully compliant with global regulatory requirements, including 21 CFR Part 11 e-signatures, and is a fully CDISC-Compliant system. We are one of only a handful of centres that self-host this electronic data capture system, making us very unique in our capabilities.
A quality system should enhance, not hinder, a clinical research project. A rock-solid research informatics platform like RAVE® helps ensure quality data is collected at the sites, making data management and monitoring more efficient and cost-effective. More importantly, by self-hosting, the AHRC can be both nimble and innovative in design and access to delivering results.
While the AHRC has full-range capabilities, we have also successfully partnered as the methods centre and data coordination centre (DCC) in several projects. This type of partnership allows industry to continue to partner with their trial coordination centre while leveraging the AHRC’s methods expertise and quality research informatics platforms.
The quality of our electronic data capture systems (EDCs) are further enhanced by our Standard Operating Procedures (SOPs) and system validation activities. In addition, the AHRC continues to add strength to employee background, training and experience as our staff are required to document all training and readings in training files. The SOPs are designed to provide direction so there is uniformity in how things are done and that quality is embedded in practices.
At times, SOPs can either be so specific, or so numerous, that research procedures are hindered and do not result in enhanced quality. It is important to identify procedures and processes that absolutely require an SOP to ensure quality. The AHRC’s quality focus is on ensuring that SOPs are adhered to as well as being relevant.
Natascha Kozlowski is the Manager of Research Quality and Process at the HUB.