In recent years, the application of electronic Clinical Outcome Assessments ePRO/eCOA has surged in the pharmaceutical sector. This trend not only reflects the rapid digital transformation in healthcare but also embodies a profound understanding of patient-centric research methods. Global regulatory agencies, such as the FDA, EMA, CDE, and other national and regional drug regulatory bodies, have explicitly voiced their support and encouragement for the use of ePRO/eCOA.

Furthermore, regulatory agencies in multiple countries have revised their guidelines for ePRO/eCOA, particularly in regions like the United States, the European Union, and China. Documents such as the FDA's Patient-Focused Drug Development and the EMA's Guideline on Computerized Systems and Electronic Data in Clinical Trials have emphasized this. The continuous optimization and updating of relevant regulations and policies have further ensured the security, compliance, and efficiency of ePRO/eCOA data.

As a digital practice in clinical research, the real-world application of eCOA still faces challenges such as limited scope of application, imperfect information systems and user-unfriendly interfaces, which are issues that urgently needs to be resolved in the industry.

To promote broader adoption and iterative improvement of eCOA, the industry is implementing a raft of measures, including strengthening system R&D and innovation to enhance its scope of application and compatibility; refining user interface design for a superior user experience; and ensuring compatibility with complex studies to expand research field support.

ACCMED's ePRO/eCOA solution — ACCMED-eCOA is in a constant state of evolution. What fresh optimizations and highlights does this latest version bring to the table? Let's drive deeper together!

User-Friendliness and High Compliance

In clinical trials, user-friendliness serves as a critical factor that directly impacts patient engagement and data accuracy. Conventional data collection methods often overlook the user experience of both patients and researchers, leading to low data entry efficiency and poor study compliance.

ACCMED-eCOA provides a clear and intuitive user interface along with detailed completion guidance to help subjects better understand operations and data entry processes. The system supports data breakpoint caching and real-time transmission, ensuring data integrity and accuracy even under unstable or interrupted network conditions. Font adjustment functions cater to the reading needs of subjects across different age groups, particularly middle-aged and elderly subjects. Through its user-friendly design, ACCMED-eCOA aims to maximize user experience and minimize difficulties and obstacles during the reporting process.

Broad Adaptability Across Diverse Scenarios and Terminals

Clinical trials often involve multiple scenarios and terminals, each presenting unique requirements for data reporting and management. For example, subjects may self-report data from home while site staff manage data in hospital settings. Traditional solutions struggle to adapt to these dynamic research environments, restricting both the scope and real-time availability of data collection.

ACCMED-eCOA provides deep adaptability to various research scenarios, supporting cross-platform data entry through mobile apps, tablets, and web portals to allow subjects to conveniently submit data from any terminal. The system offers proxy reporting modes for subjects unable to complete assessments independently, while biometric authentication features ensure data accuracy by preventing erroneous entries. This flexible adaptability enhances the breadth and real-time responsiveness of data collection across diverse clinical environments.

Comprehensive Support for Complex Studies

Since complex clinical trials often involve vast amounts of research data and information, how to efficiently manage and analyze such data presents critical challenges. Traditional eCOA platforms lack adequate support for complex scale scoring and multi-dimensional data monitoring, which not only limits the depth and scope of research but also compromises data quality and outcome reliability.

ACCMED-eCOA provides robust support for complex studies by automated scale scoring calculations and streamlined data processing workflows. Its multi-faceted data monitoring capabilities, such as compliance reminders, dashboard surveillance, and medication accuracy alerts, assist researchers in real-time tracking of study progress and data quality. Additionally, built-in validation rules and Composite scale support capabilities further ensure data standardization and accuracy.

The power of ACCMED-eCOA extends far beyond this

Rooted in domain-specific KNOW-HOW

and profound mastery of global regulatory frameworks

From physician-patient training to vast specialized scale libraries,

From logical verification configurations to project audit trail management

From unified data acquisition to cross-system operational oversight

Addressing user needs and pain points

Empowering efficient research execution