Hammersmith Medicines Research (HMR) is a full-service London-based contract research organization (CRO) specializing in early clinical trials for pharmaceutical and biotechnology companies worldwide. One of the largest CROs in Europe, HMR has earned an impressive reputation for delivering high-quality clinical trials on schedule.
Championing operational excellence is critical for maintaining this position in the context of increasing competition and protocol complexity. One of the ways HMR’s Statistics & Data Management group achieves this is by harnessing Medrio’s innovative Electronic Data Capture (EDC) system. Migrating from paper-based processes, Medrio’s scalable EDC supports the CRO to cost-effectively increase efficiency, safeguard data quality, and deliver exceptional service levels to sponsors.
Standardizing for success
For HMR’s Data Management Team Leader, Meera Patel, a primary benefit of using Medrio’s EDC is building a library of reusable study templates, which helps reduce study build time and promotes standardization.
Meera explains: “The EDC’s user-friendly and has allowed us to develop a template library where we can copy forms into study-specific databases. This helps from both a time-saving aspect and by assuring consistency between our trials, ensuring that – for example – our demography form will always look the same and always be exported in the same way.”
“We specialize in phase I and II trials and most of our databases involve safety procedures. Over time we’ve been able to create template forms in our library for common safety procedures, such as ECGs, vital signs, physical examinations and so forth. We don’t have to start from scratch or reinvent the wheel with each new study. Instead, we can simply reuse or remodel existing forms.”
Controlled deployment
When building a study database and responding to mid-study changes, HMR capitalizes on Medrio’s three-tier environment, offering users a gold standard strategy for development, testing, and deployment.
What does this mean in practice? Simple: enhanced flexibility during the configuration and testing phases, quicker and more controlled deployments.
Meera comments: “All HMR’s databases are built in the development area of Medrio before the user acceptance testing and sponsor review phases, which are managed in the system’s test environment. It’s a process we utilize at the beginning of studies but also for updates that occur part way through.
“The three-tier environment facilitates more controlled deployments by providing ample opportunity to build, tweak, and validate. This nurtures a ‘right first-time’ approach and ensures we can build out a study within an average of just five weeks and effectively respond to mid-study changes as rapidly as possible.”
Robust user management
It isn’t just Medrio’s library of reusable templates and three-tier environment supporting HMR to deliver operational excellence. The EDC’s robust user management features ensure users have appropriate access to real-time data and multi-format reporting.
Setting up new users and associated permissions is achieved quickly, thanks to functionality that enables batch uploads. HMR also creates custom user roles that can be easily adjusted by toggling on/off.
Meera comments: “We can assign and amend permissions as needed as part of an intuitive process. Instead of adding users and assigning permissions individually, Medrio allows us to download a blank user template, add all users, and upload in a single batch. It’s a feature I personally really appreciate as it saves so much time and admin.”
The optimized process for assigning user access and permissions delivers tangible benefits for key study stakeholders. Because the EDC is designed with end users in mind, clinical research staff are empowered to complete tasks confidently. Meanwhile, with read-only access, HMR’s sponsors can monitor real-time performance and generate reports in their preferred format, contributing to more transparent, collaborative, and productive sponsor/CRO working practices.
Driving efficiency and accuracy
Increasing operational efficiencies and improving data accuracy are critical objectives of any digital transformation agenda, and HMR’s migration from paper-based data capture is no exception.
Medrio’s unique product design has allowed HMR to experience new levels of efficiency. The intuitive build functionality – complete with drag-and-drop features – enables them to reach new heights of productivity– with efficiencies increasing with repeated use.
For Meera, functionality like automatic query firing and skip logic help HMR to streamline further: “The difference between using paper and using Medrio EDC is night and day. One of the most obvious ways this presents is through process automation. With Medrio, as soon as you save the page, queries are fired depending on what we need them to do, which is incredibly useful. Similarly, features such as skip logic have also delivered considerable value by minimizing data entry errors, especially when procedures are not done or might not be required. These factors combined allow us to work more efficiently while boosting data accuracy.”
The system also supports HMR to maintain real-time visibility over its trial data while providing a secure clinical database to uphold data quality and complete audit trail visibility. This means HMR monitors and its sponsors can review the data continuously, contributing to expedited closeout processes and potentially lowering costs.
A proven partnership
With eight years of Medrio experience, HMR’s Statistics & Data Management department has become expert in EDC best practices. From working with statisticians, programmers, and data managers to ensure each build meets unique endpoint requirements to developing internal training and support escalation processes: you name it, they’ve got it covered.
But what’s made the partnership work so well for the best part of a decade?
Meera comments it’s not just about having a sophisticated yet user-friendly product with a transparent and competitive pricing structure. It’s the people that make the partnership a proven success.
“We’ve enjoyed a close working relationship with Medrio over the years. Medrio has taken the time to understand our business, processes, and operations, who we are and what we need our EDC to deliver. There’s no hidden agenda; there’s no hard sell. There’s a genuine interest in supporting us to achieve success, offering guidance on opportunities for continuous improvement, and collaborating to deliver the best for our sponsors and patients.”
Learn more about Medrio’s EDC.
