ePRO/eCOA Capabilities to better conduct Clinical Studies
ePRO/eCOA tools have revolutionized the clinical research industry. The first concept was raised a decade ago, but the idea of integrations between systems or interoperability was far from easy.
In the past three years, the industry has experienced a boom of new technology development, broadening the data source and protocol design possibilities for Sponsors, sites, and CROs, as well as each country’s research field. Indeed, the COVID-19 pandemic affected and challenged the speed, efficiency, patient focus, and data capture capabilities were already needed.
Reporting electronically and centralizing the patient-reported data have led to great benefits in terms of accuracy, real-time metrics, and data entry time reduction.
In 2021 the FDA published the Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Guidance for Stakeholders, acknowledging that data capture increase opportunities to connect participants and investigators, performing decentralized clinical trials. In addition, “remote data acquisition address challenges associated with centralized trials, such as the burden of traveling to the trial site for participants, especially for the ones with physical or cognitive limitations, time constraints, or for those who may be geographically dispersed”(1).
Clinical Trial in Latin America: A Fertile Field
Latin America has become a great opportunity for researchers. Among others, due to the population (600+ million), large cities with top healthcare services (+18.000 hospitals), diversity, light-cost healthcare (44%-89% less than US vs. Costa Rica ), high efficiency, clinical results, and quality.
Additionally, vendors like Integra IT have adopted international standards and regulations that guarantee compliance and software security best practices. Likewise, we have innovated in developing our TrialPal (eCOA/ePRO) tool features to achieve high-performance rates and deliver efficient clinical trial operations in emerging countries and vaccine clinical trial operations.
Here we share the top ePRO/eCOA capabilities that have contributed to delivering successful clinical studies in Latin America:
- Patient-centered solutions: TrialPal (eCOA/ePRO) tool is designed and tested in different groups of ages from multiple Latam countries; as a result, we improve user experience by customizing features like font size, button size, icons, navigation, dark or light modes, and workflows. These have a great impact on UX, adoption, and reporting rates.
- Offline and online mode (Works without Internet access): Access to a broader range of patients, even in rural zones with limited internet access. TrialPal saves the report on the device; once it is back online, all the pending data is sent automatically.
- BYOD – Device provision and management: This capability will enable to make diverse recruiting, more easy set-up, and improve the reporting adherence rate. It is important to coordinate logistics to give participants access to reliable mobile devices with internet access, as well as complete training and support. In Latin America, 72% of the population has internet access (3).
- Fast start-up capabilities: Time is the most valuable asset for all stakeholders in clinical studies. Having the ability to reduce the start-up time and make a fast set-up will accelerate the study timeline. TrialPal is designed to have an agile, customizable and remote deployment where: The eDiary is set up in 2 hours, with screenshots ready for EC Submission in just one day. TrialPal and its modules, eDiary, active and passive forms, eConsent, etc., are already integrated into RAVE EDC through a proprietary API that can also be integrated with other third-party systems.
- Local and in the same language technical support: According to ClinicalTrials.gov, from the 432,983 registered studies, 53% are non-U.S. Therefore, having a regional and globally experienced vendor delivering empathic support is key to an efficient performance, including Sites. The latest feature enables site conciliation to record the physician’s notes to subjects’ reports easily.
- Ease to use Site Console to Manage Subject Visits and reporting: TrialPal has embedded the TrialPal Site console where Sites can see in real-time subject report status, eDiary Cards, and form submissions, and together with automated alerts and notifications, they can quickly take decisions toward the clinical study objectives.
- Newest USSD eDiary for emerging countries: Integra IT has developed an eDiary through a dial pad flow vía USSD. A mobile communication channel that doesn’t require internet, just a telecom network. USSD broad access to clinical trials in countries or regions lacking internet coverage, like Sub-Saharan Africa, through basic cell phones; thus reducing operational costs and technology adoption barriers.
In conclusion, ePRO/eCOA capabilities and tools must adapt to the context of the region. Integra IT TrialPal App, together with its modules and API, is the perfect match for Latin America and emerging markets-located studies, thanks to its high efficiency, compliance, and patient-centered approach.
Integra IT has a completely modular ecosystem for Sponsors, CROs and sites, under a light-cost and high-efficiency model, aiming to expand the clinical research possibilities with accessible and flexible eSources capabilities.
Learn more about TrialPal and its features at:
- FDA, 2022. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Draft Guidance for Industry, Investigators, and Other Stakeholders. Link:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations [Cited: November 2, 2022]
- Jantra, 2022. An overview of Latin American healthcare systems. Pacific Prime Latin America. [Cited: November 4, 2022] Link: https://www.pacificprime.lat/blog/an-overview-of-latin-american-healthcare-systems/
ClinicalTrials.gov, 2022. Trends, Charts, and Maps. Resources. [Cited: November 8, 2022] Link: