Just like any company engaged in pharmaceutical research, MRN lives in an environment of continual audit. Our audit schedule each year is populated with Sponsor/CRO audits, internal audits, and audits of our vendors. Audits may appear, to some, to be an unwelcome additional overhead to our day jobs, but the truth is that audits are a vital part of ensuring patient safety and trial data integrity. Audits are part of business as usual, and they ensure that, collectively, MRN, sponsors, and vendors keep patients safe. Whilst, of course, no one wants to receive a finding during an audit, they are one of the greatest opportunities for a company to improve its processes or systems. Findings, especially those leading to a CAPA process triggered by any audit finding help MRN drive continuous improvement that ultimately benefits our customers and patients.
How is this so? Once the root cause analysis has been completed here at MRN we immediately put in place any corrective actions to remedy the identified risk or issue. But when we start to drive through Preventative Actions we have an opportunity to frame the work through continuous improvement change initiatives.
At MRN our Continuous Improvement Office (CIO) and our Information Technology (IT) Application group operate using Agile methodology. Any change program, whether it be process, IT, or both is structured into 2-week ‘sprints’ that enable us to deliver tangible benefits to the business rapidly. Many of our projects are initiated by strategy and business needs, but we also dedicate substantial resources to implementing change programs that are driven by CAPAs, Quality Processes, and operational experience. Preventative Actions inevitably lead to a change in process, IT, or both, and the most important aspect of any change is how you manage that change. Everyone will have experienced poorly managed change that resulted in poor implementation and/or discontent. This is why, at the MRN, we employ dedicated change managers whose focus is on delivering effective change, utilizing consistent methodology.
Change Management initiatives, even with short 2-week sprint cycles, need to be carefully managed to ensure that our busy operational teams can buy in to and understand the underlying requirements to change the way we do something. We aim to operate with a benefits realization focus that encompasses safety, commercial and personal factors. We wrap all changes up with aligned training and standard operating procedure documentation to support people in their roles.
MRN has been operating for nearly 17 years, leading the Decentralized Clinical Trial (DCT) market, and whilst MRN has been pioneering approaches through deep understanding and interpretation of legislation to better support patients, it is only post-pandemic that Regulators and auditors are beginning to really understand our model. Industry narrative would suggest that the “D” in DCT is all about digital. It isn’t. Digital is one way to support DCT, and at MRN we use digital tools to support our Home Trial Support and Site Support work which above all else is focused on innovation and people whilst meeting regulatory requirements – whether HCPs, client representatives or patients. As Regulators and Auditors develop their understanding of decentralized clinical trials and become more aware of innovative models that can support trial delivery, this becomes an exciting opportunity to benefit from their understanding and experience to further drive change in how we operate – In isolation, we will all become stagnant, and so we welcome change and exchange of ideas, whether as a result of an audit, updates to legislation, or based on our experience.
At MRN we have the processes and the teams to drive changes, but at the heart of it all, we are one MRN and we all work together – Quality, Operations and Business support functions – to ensure that we deliver benefit driven change to everything we do.
Authors:
Malcolm Horsley, VP Business Quality Development
Julian Meekings, Executive Director Quality Management