Suvoda - Model eCOA - Unify eCOA and IRT Systems
Overcome the traditional challenges of electronic outcomes data collection and submission for complex clinical trials.
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Details
Device deployment, returns, resupply, and reporting. Assessment licensing and localization. Multilingual tech support for sites. These, and other, operational challenges have historically plagued the deployment of eCOA systems.
But putting together the products, people, and processes that can smooth complex logistics behind mission-critical, time-sensitive patient interactions is what drives all of us at Suvoda. So, leveraging decades of global experience, our IRT and eCOA experts set out to redefine the bar in electronic outcomes assessments tools.
The result? Suvoda eCOA. An application that works in conjunction with our Suvoda IRT to minimize workflow frictions from patient consent to data submission. A system that’s built with the same rigorous development processes and supported by the exceptional client services teams that we’ve become renowned for. A tool that empowers you to manage the movement of devices and assessments—as securely and flexibly as our IRT system manages your drug supply—and makes complete, accurate, and protected outcomes data available whenever you need it.
Architecture
To your study and site users, Suvoda eCOA administration activities will simply appear as additional functionality within our IRT system. Why? So that data is seamlessly shared, workflows are fully streamlined, and the process is completely controlled. Suvoda eCOA device allocation and account set up is initiated within the IRT environment during a patient’s first study visit. Fully aware of all patient interactions within the eCOA system, our IRT logic will enable accurate and complete data collection. And site users can proactively monitor patient compliance in real-time for diaries and questionnaires required by your protocol.
An added benefit to this seamless eCOA and IRT architecture? It minimizes the human errors and data duplications that result when users must manually enter information between two systems, and eliminates the data integration cost and effort when working with disparate systems.
Design
Receive a submission-ready archive that can support your New Drug Application (NDA) submission. Ensure clean data transfers to your EDC system. These are the end goals Suvoda experts have designed into every aspect of our eCOA offering.
In practice, it means our client services teams can more intelligently configure our modular system to both capture and compile patient outcomes data based on a client’s unique trial protocols, data standards, and regulatory considerations both at trial start and for mid-trial amendments. So site teams will find the complex logistics of getting the right questionnaires to the right patient at the right time are easily and securely managed—just like the drug supply in our IRT system. And study teams will be able to quickly and accurately ingest or export appropriately-formatted clinical data sets, for mid-trial analysis, final submission, or follow-up audits, on demand.
UI
Study and site teams will find the user experience to be calming, familiar, and focusing. That’s because we based it on the minimalist look and feel, intuitive navigation, and patient-centric processes of our well-regarded IRT system.
But the collection of clincal outcomes data is an activity increasingly in the hands of patients, often at home, without supervision, rather than by trained clinical trial professionals. So we’ve taken added steps to ensure that patients find their interactions with eCOA questionnaires and diaries to be simple. Even the initial setup of their eCOA device at the site through our IRT system is managed through a simple, secure, QR-code-driven download. It’s a wise way to give patients a better clinical trial experience—and get you higher quality outcomes data.
Reporting
Do you need to see what countries, sites, or patients are struggling to comply with eCOA requirements? Are you looking to determine the activation, battery level, and sync status of all in-clinic or at-home eCOA devices? Will you want to perform an audit of all eCOA data changes? No problem. They—and others—are all standard, pre-set reports in our IRT system.
Even better, our much-loved IRT ad-hoc reporting function is available for eCOA as well. So you can build your own analyses, on the fly. Because though it’s our software, it’s your data. Our goal is to simply give you the wisest possible access to it.
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