Cevaxin a Site, a research Site located in Panama, used TrialPal to achieve an outstanding eDiary reporting compliance rate in a Phase I vaccine clinical trial with older adults.
While developing clinical trials, research sites usually face common challenges, such as technology adoption regarding participant reporting and timely monitoring. Understanding this and the particularities of the vaccine clinical trials require large participant groups, multiple ages, and strict surveillance. Integra IT has worked closely with the site network to guarantee successful outcomes and conduction.
In a Phase I clinical trial, which objective was to evaluate the safety, reactogenicity, and immunogenicity of an influenza vaccine in the Cevaxin Site in Panama City. Integra IT provided the TrialPal Mobile and web application for the data gathering process.
TrialPal, subjects’ best friend in a clinical trial, is an eCOA/ePRO intuitive and easy-to-use application tailored for vaccines that allow symptoms reporting, monitoring and notification during each phase of a vaccine clinical trial. TrialPal includes a self-customizable setup tool, symptoms grading, alerts, and a consolidated set of real-time dashboards with a study symptom executive view for timely decision making.
Participants provide information through two modules; eDiary for daily reports during the first seven days post-vaccination and the Surveillance module for AE and SAE during the entire trial life cycle.
eDiary Strategy Pinpoints
- Integra IT built a quick and practical training program for the participants, led by an experienced team who also trained the site staff and physicians in using TrialPal.
- The Integra IT team understands the native language and cultural barriers. To close the gap, a specific local on-site support team was chosen to stay close to subjects as well as to the healthcare professionals during the enrollment process, always open to answer questions in the same terms.
- The development team has created a user-friendly flow and design interface. They have tested the TrialPal App usability in different age groups and provided adaptation features such as font size, button size, and graphic helps.
- The first seven days of the vaccine clinical trials are essential to the CRO and the sponsors, therefore critical notifications and alerts were set up so participants don’t forget to complete the eDiary, and the Site staff is notified to act immediately when grade 3 or high-intensity grading is reported or just for monitoring.
- Automatic reports for the site staff to perform patient follow-up
- The 97.6% eDiary reporting compliance rate in older adults results from a good design, high-end technology tool, and a personalized support strategy.
- This case helped the Site identify findings and improvement opportunities during the point of care.
- Due to the high adherence rate, the stakeholders could access real-time and reliable data about the trial outcomes.
- Participants had a better experience and satisfaction rate.
- TrialPal sped up the analysis process and gave early insights to sponsors.
- The Site delivered excellent results and retained the client for more trials.
Moreover, the new version of TrialPal includes the TrialSite management console, which enables participant enrollment and set-up study protocol, forms, notifications, alerts, and reports.
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