As part of bringing diagnostic and medical devices to market, electronic case report forms are created for databases in which important findings on the effectiveness and safety of results are collected and evaluated.
Tasks
A client is required to conduct clinical studies as part of the market launch of diagnostic and medical devices. During these scientific investigations, large volumes of data are collected, organized, and analyzed within clinical and technical data management processes. Using electronic Case Report Forms (eCRFs), central study data is captured and tracked, enabling important insights into the effectiveness and safety of outcomes.
EXCO supported study teams in designing the required eCRFs, ensuring that data can be collected and prepared in accordance with FAIR Data principles and internationally recognized standards such as CDISC (CDASH, SDTM, ADaM) and LOINC for data exchange, integration, and analysis. In doing so, EXCO provides valuable support for both clinical and technical data management.
Implementation
- Design and specification of eCRFs based on study protocols, requirements review
- Implementation and updates of eCRFs in the client’s preferred system
- Validation of study implementations within the system, including:
- Developer Testing
- User Acceptance Testing (UAT)
- Preparation and maintenance of documentation in compliance with regulatory requirements in a highly regulated environment
“By developing eCRFs, I ensure that clinical study data can be collected according to high quality standards, thereby creating safety and reliability.”
Client benefits
- Enhanced Expertise: The client gains access to expanded expertise in secure and compliant data analysis through the outsourcing of specific software development activities.
- Continuous Support: The client receives ongoing and reliable support for all eCRF-based study projects.
Client
Manufacturer of diagnostic medical devices
