By: Andrés Escallón, Vice President, eCOA Solutions Strategy
Snapshot:
- eCOA and IRT enable better decision-making: Together, they enable faster, more accurate actions during key trial moments.
- Unified platform helps data integrity: A shared data layer reduces synchronization errors and provides the most up-to-date information.
- Improved operational efficiency: A single, intuitive interface for site users and consolidated support teams simplifies trial management and reduces the learning curve.
As eClinical technology advances, sponsors have more and more requirements and options to help manage their clinical trial operations. This increasingly complex technology landscape can add stress to the study start up period, which can push sponsors to fall back on (for good reason) the tried-and-true solutions that have worked well for them.
When it comes to Electronic Clinical Outcomes Assessments (eCOA), traditionally, it has been used as a standalone system or paired with Electronic Data Capture (EDC), a combination that has worked in many ways. And yet, as trial complexity has grown and technology capacity has expanded, it’s worth considering how we can innovate in eCOA to address new trial needs. Those needs might include:
- Flexibility and configurability based upon a protocol’s schedule of events, for example, in the case of changing visit schedules, common in oncology trials.
- Responsiveness to mission-critical moments in a patient’s progression through a trial, especially for complex therapeutic areas like oncology and rare disease.
- Ability to adjust based on real-time data entry, like responding to eCOA compliance rates for difficult-to-reach populations like adolescents.
- Real-time alerts if something doesn’t go as expected.
Those requirements, and more, can be satisfied when eCOA is on a platform with Interactive Response Technology (IRT). Together, they connect patients, sites, and data in real-time across trials, in the most mission-critical, time-sensitive moments like screening, randomization, visits, post-visit diaries, and end-of-cycle reporting.
Here are 5 reasons why eCOA belongs with IRT:
#1: More accurate decision-making when it matters most
Clinical trials are complex, with strict timelines and increasing demands for efficiency and accuracy. When eCOA and IRT sit on the same unified platform, they operate as a single system, with all of the capabilities of both solutions working together seamlessly to support sponsors and sites to manage time sensitive, in-the-moment actions. For example:
- At Enrollment: The eligibility status of patients can be updated immediately based on eCOA data collected for screening, without having to wait for an EDC update.
- During Visits: eCOA questionnaire windows can adjust in real-time to changes in visit schedules, essential for trials with complex and changing schedules such as oncology studies.
A unified eCOA and IRT system means that eCOA data is instantly synced to IRT, and vice versa, so that things like dosing changes prompted by eCOA data are accurately reflected.
One of our Suvoda customers shared how this was important for their studies, "Suvoda IRT and eCOA share a single database—something I found to be crucial. Randomization relied on eCOA data, which was instantly available with no integration concerns. Unlike other studies, site users had seamless, immediate access through one system.”
#2: Single source of truth for data integrity
A shared data layer on a unified eCOA/IRT platform results in greater data integrity, giving all stakeholders access to the most current and accurate data to facilitate timely actions. This setup minimizes the risk of data synchronization errors and time-consuming data reconciliation, while still supporting smooth API-based integrations with EDC systems.
#3: Visibility across major systems for day-to-day trial operations
The combined view of patient data, drug status, and site operations across key eClinical systems—IRT for drug logistics and eCOA for data collection—enhances operational coordination all while maintaining the study blind. This consolidated oversight aids study teams in making informed decisions swiftly and accurately and helps them quickly identify potential compliance or data issues that may need to be resolved before data is passed to EDC.
#4: Streamlined support and service
When selecting a platform, sponsors are also selecting the people and teams who will be there to support their trial. A single support team that understands both systems can provide expert consultation to assist with protocol implementation and amendments, as well as help with integrations to other eClinical technologies through an API layer.
#5: Familiar user interface for site users
A majority of all eClinical users are site personnel, so their experience really matters. A unified eCOA and IRT system offers a consistent and intuitive interface for site users managing critical tasks, whether they are involved in dispensing drugs or completing clinician-reported outcomes. This consistency reduces the learning curve and burden of switching between systems and ultimately improves operational efficiency.
Decision-maker checklist: Should eCOA pair with IRT?
eCOA makes sense with IRT
Joining eCOA with IRT on one unified system like the Suvoda Platform empowers clinical trial teams to make informed and insightful decisions swiftly, thanks to the real-time, accurate data shared across all trial tools. Other approaches may provide some aspects of data sharing via integrations, but they can struggle to operate as a single system that works simply, elegantly, and quickly. With the Suvoda Platform, sponsors have a powerful technology ecosystem to handle the most urgent moments of their clinical trials with more streamlined and efficient operations and with shared data to drive insight-based decisions.
Author
Andrés Escallón
Vice President of eCOA Solutions Strategy,
Suvoda
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