Hitting new heights of clinical quality with Qualio
The Wellcome-HRB Clinical Research Facility (CRF) is a state-of-the-art clinical research partnership between Saint James' Hospital and Trinity College Dublin.
From its research pharmacy to its aseptic compounding suite, the Facility specializes in delivering clinical trials with optimal standards of quality and regulatory compliance.
The Facility sponsors its own trials, and works with external sponsors such as Pfizer and Novartis.
Consistent Good Clinical Practice is of critical concern to Wellcome-HRB's quality team: Kishor Santhosh and Sruthy Thoniparambil Vinesh.
Kishor and Sruthy are responsible for managing the organization's quality and compliance activity, and ran monthly quality reviews to spot nonconformances and protocol deviations.
But their QMS was run entirely on paper.
Maintenance of documents, management of protocol deviations, of nonconformances, change controls, suppliers: everything was paper-based.
The organization's grown leaps and bounds in the last 4-5 years, and it became extremely difficult to manage all those.
The Facility's paper-based quality processes took up significant time, with CAPAs difficult to build and close out.
Staff training was difficult to track, and there was no effective way to ensure that employees actually understood their operating procedures.
And with no centralized system for quality and compliance, the team found it difficult to prepare for audits and sponsor reviews, with some nonconformances and protocol deviations only spotted by sponsors.
It was clear that a more modern quality approach was required to keep up with the CRF's rapid growth and new trial expectations.
In 2023, Wellcome-HRB decided to transition to an electronic quality management system (eQMS).
After evaluating several vendors, including Q-Pulse and Veeva Vault, the team selected Qualio as the optimal choice due to its user-friendly interface, price, and its ability to meet the organization's specific needs through flexible configuration.
Qualio fit our needs better, in terms of performance, design, dashboard, ease of use, how cost-effective it was, what we could do to it - and what it could do to us!
After a detailed scoping exercise, Wellcome-HRB became Qualio customers in late 2023.
Qualio's Onboarding Manager Casey Huxtable guided Sruthy and Kishor through their implementation process, ensuring all departments within the Facility - from quality team to pharmacy lab, nursing staff and doctors - were trained on the system and ready to begin their new paperless approach.
Wellcome-HRB went live with their new eQMS in January 2024.
Qualio delivered dramatic results for Wellcome-HRB immediately, with Sruthy and Kishor beginning with the Documents, Training, Events and Analytics areas of the system.
The impact of Qualio became clear when Sruthy and Kishor conducted a comparative 'before and after' review, adding their findings to a poster presentation which took first prize at the UKCRF Annual Conference 2024.
The agility and efficiency unlocked by Qualio empowered Kishor and Sruthy to move from monthly to daily quality reviews, building a more proactive and real-time approach:
This, in turn, allowed more protocol deviations to be detected, with faster resolution and better QMS visibility bringing the number of non-conformances and significant deviations down by 50%:
Process speed also took a dramatic boost, with Kishor estimating a week saved for every single new SOP publication - down to 3 days from 10.
Cleanroom monitoring processes for the Facility's aseptic compounding suite were moved into Qualio, too, improving the quality and integrity of those key areas.
And staff satisfaction skyrocketed, with Qualio's intuitive UI and high levels of automation removing the headache from quality and compliance and helping a collaborative quality culture take root.
The Facility's optimized digital quality has paid off, with improved sponsor satisfaction bringing a jump in Phase I trials in the pipeline from 1 to 5, and the Facility being widely recognized by key sponsors as an optimal, GCP-centric operation to trust with complex trials.
Sruthy and Kishor are only just getting started with Qualio, and plan to expand user numbers and bring their suppliers and vendors into Qualio Suppliers for more effective supply chain auditing.
The future is looking very bright for the Wellcome-HRB CRF - and for the thousands of patients set to benefit from the gene therapies trialled within its walls.
We couldn't do daily checks with our old system. It was too difficult to document it and get it running. But now we can.
Findings are logged as Qualio events and triggered for the right person, and they get fixed.
The quality of the entire research facility is up. Findings are drastically down.
And we get that feedback from our sponsors who notice that as well.
We are super satisfied.
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