Managing quality at every step, DZS ensures industry leading results
By Kathryn E. Vinson, MS, CCRC, with input from Karyn Thompson, QA Manager, DZS Clinical Services
As the world becomes more and more focused on the clinical research industry with the long-awaited results of COVID vaccine trials, the importance of quality in research has taken center stage. While the lay public seems to have just noticed these aspects, we in the clinical research industry have known the importance of quality since our careers began. But when we refer to quality in research, we mean so much more than crisp data; quality starts at the top and is demanded at every step. Today we here at DZS Clinical Services would like to take some time to discuss how we manage quality and ensure that your trial is the pinnacle of success.
As a CRO, we have a duty to our sponsors to find the best sites for each trial. Just as every trial is unique, every site is as well. From large to small, from multi-specialty to single-specialty, each clinic in our portfolio of partner sites has the ideal solution for your trial. Site selection and feasibility begin with a thorough understanding of not only the protocol and study requirements, but also of the strengths and abilities of potential sites. While a research naïve site may be eager to work on a trial, our project managers know that complicated studies may not be appropriate until they have proven their abilities.
Site Regulatory Compliance
Just as it is vital for coordinators to keep excellent source documentation and case report forms, so is it crucial that sites maintain scrupulous regulatory documentation. Good documentation is crucial in any clinical trial. DZS site monitors work with site staff to ensure essential documents are current and available for audits or inspections. Quality Assurance audits of clinical trial documentation is another layer of oversite to confirm compliance with ALCOA+ standards (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
While every coordinator dreams of a flawless study, with no dings on their QA audits, even the most experienced and successful researcher inevitably has a minor flaw found in their work. While we do our due diligence and hope that audit findings show nothing more than a hard to read date, auditors often show us areas where we can improve. At DZS, we look for sites that employ quality checks by their own SOPs, as well as active monitoring of eCRFs via the Insight Platform. This dual layer of quality assurance provides sponsors with the crisp, pristine data that they need.
Despite the anxiety that may be provoked by inspections, every quality check and every sponsor audit provide research professionals at all levels and at every position with the ability to learn from past mistakes. Be it as simple as clearing up handwriting errors, to incorrect date formats, to more serious protocol compliance issues, we see quality assurance as a way to educate ourselves and sites.