Have you ever observed a health informatics project in your (other) organization? Please provide a brief introduction.
I am currently employed at an eClinical Solutions company in Canada. We specialize in Electronic Data Capture (EDC), a technology used in clinical research to electronically collect, manage, and analyze clinical trial data, thereby replacing traditional paper-based methods. EDC systems are meticulously designed to streamline data collection processes, enhance data accuracy, and improve the overall efficiency of clinical trials and healthcare data management.
Our EDC system, known as the “Fusion eClinical Suite,” is an easy-to-use and cost-effective eClinical solution that caters to small to medium-sized device, pharmaceutical, and biotech companies. It boasts over 15 fully integrated modules that seamlessly connect within a unified platform. These modules include eSource, ePRO/eDiary Mobile App, IWRS/RTSM/Cohort Management, Central/Local Lab Import, data management and so on, they are all accessible with a single sign-on.
How can this health informatics project help to improve the current practices?
Efficiency: EDC automates many manual processes, such as data transcription and data entry, leading to significant time savings and reduced administrative burden. Researchers and healthcare professionals can focus on analysis and patient care rather than data management.
Real-time data entry: EDC allows for immediate data entry and verification, reducing delays and ensuring that data is up to date. This is especially valuable in clinical trials where timely decisions are critical.
Remote data collection: EDC enables remote data collection, reducing the need for on-site visits and allowing participants to input data from their own locations, which can enhance patient recruitment and engagement.
Data monitoring: EDC systems offer real-time data monitoring and auditing capabilities, making it easier to identify and address issues promptly, ensuring data accuracy and compliance.
Unified customization: EDC systems can be tailored to the specific needs of research studies and healthcare facilities, offering flexibility while maintaining data standardization.
Data archiving: EDC systems provide efficient data archiving and retrieval, making it easier to store and access historical data for future reference or regulatory audits.
Are there any challenges or difficulties in implementing the project?
Integrated system improvements: EDC systems need to further investigate and integrate seamlessly with other healthcare or research systems. Data has not been completely imported/interpreted from another system or error e.g. to import data from Central/Local Lab Import into Fusion eClinical Suite is not fully triggered in real-time.
System downtime and reliability: EDC systems need to be highly reliable to avoid disruptions in data collection and analysis. Downtime or system failures can lead to data loss and delays in research activities e.g. Study Monitor was unable to access files within eTMF module, the report was error upon generating or taking too long when to generate the applicable report for All Sites.
User-friendly improvements: Due to language barrier for non-English native speakers (for patients) that they had difficulty to utilize the ePRO/eDiary Mobile App or eConsent Portal upon their completion, and there are too much information for users within user guideline documents upon their training completion to gain access into the system.