Overview

Purpose-built with users at the center to make it easier and more efficient to get quality patient outcomes data for submissions and approvals. 

Collecting quality data on patient outcomes is often one of the most important parts of a clinical trial. It is also challenging, and many eCOA solutions make it feel even more difficult with complicated processes, lack of questionnaire reusability, slow set up, and difficult to use tech.    Suvoda eCOA, coupled with our expert scientific and operational guidance and streamlined licensing and localization, relies on our patented software architecture to solve those problems so teams and implementations are more efficient, especially in the most urgent moments. Suvoda eCOA supports sponsors and CROs to:  

• Accelerate eCOA questionnaire creation and deployment, taking eCOA off the critical path so trials can launch more efficiently 
• Minimize the many stresses that plague traditional eCOA solutions and delivery
• Streamline the collection of accurate patient data for high-quality study submissions
• Empower sites to focus more time on patients Sponsors can partner with Suvoda’s scientific advisors and licensing experts to guide eCOA implementation. 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 just like IRT and eConsent, Suvoda eCOA is supported by our intuitive user experience, standard and ad-hoc reporting, and customer support.

Features

Robust functionality that drives data integrity, streamlined questionnaire licensing and localization, and efficient implementation.

With exceptional functionality to solve common and unique challenges of eCOA implementations, Suvoda eCOA and our expert scientific, licensing and localization, and operations services teams can do exactly what your study needs, efficiently. The result? High-quality data that studies need for regulatory submission. Efficient Implementation Patented questionnaire design tool, Suvoda Questionnaire Design Language: 

• Expedites questionnaire creation, translation, layout, and deployment. 
• Empowers study teams to seamlessly implement a single questionnaire across multiple studies. Suvoda’s Questionnaire XD:
• Decouples questionnaire management from the system build, so localization can start earlier and allowing mid-study changes if necessary.
• Simplifies localization and translation implementation.
• Enables collaborative, efficient, and agile translation management in electronic, compliant workflows. Support for BYOD (bring your own device), provisioned device, and hybrid models. Centrally Managed Licensing & Localization
• Repository of translated and validated questionnaires that can be used across modalities, devices, and studies.
• Suvoda’s in-house experts manage questionnaire licensing, translation, and localization. Translation vendors work directly in the system to streamline localization.
• Established partnerships with license holders and translations vendors to simplify reusability and validation. Drive Data Integrity Single platform and database:
• Enables seamless flow of information between IRT and eCOA.
• Reduces duplicate data entry.
• Supports clean data transfers to EDC.
• Allows control over patient eligibility, randomization, stratification, and dose management, based on questionnaire inputs.
• Allows mid-study analysis.
• Delivers an inspection-ready and submission-friendly archive. A suite of standard, pre-set, and ad hoc reports:
• Provide real-time visibility to patient data across eCOA and IRT.

Built on our single clinical trial technology platform, Suvoda eCOA and IRT simplify outcomes data collection and submission.

To your study and site users, Suvoda eCOA and IRT administration activities will appear in a single unified interface. Why? To simplify your day to day. You can be more efficient with data that is seamlessly shared, streamlined workflows, and a process that is completely controlled. Suvoda eCOA set up is done easily when the IRT functionality is used during a patient’s first study visit. Our shared application logic across eCOA and IRT will enable accurate and complete data collection. And site users can proactively monitor patient compliance in real-time. Added benefits to a seamless eCOA and IRT architecture? Accuracy, integrity, accessibility. With eCOA built on the same platform as IRT, sponsors reduce manual data entry at sites, creating an always-on, single source of truth. This reduces errors, increases accuracy, increases data integrity, and delivers real-time visibility to patient data that can inform drug supply.

Digital experience that makes eCOA equally simple for clinical trial professionals and their patients. 

Study and site teams, as well as their patients, will find the user experience to be intuitive, easy to navigate, and well-designed, as validated through usability testing conducted by RWS Life Sciences.1 That’s because we based it on the minimalist look and feel, straightforward navigation, and patient-centric processes of our proven IRT system, implemented in over 1,500 trials worldwide. The collection of clinical outcomes data is an activity increasingly in the hands of patients, often at home, to complement outcomes data reported by observers and clinicians. So, we put the system user at the center of our eCOA design process to ensure that patients, observers, and clinicians find their interactions with eCOA questionnaires and diaries to be simple. Even the initial setup of the eCOA device at the site through a shared workflow with our IRT system is managed through a simple, secure, QR code download. It’s an elegant way to give patients a better clinical trial experience—and produce higher quality outcomes data.

Real-time eCOA status at your fingertips through Suvoda IRT’s pre-set and ad-hoc reports.

Do you need to see how specific countries, sites, or patients are complying 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. Though it’s our software, it’s your data. Our goal is to give you what you need to make informed decisions, quickly.