EDC and ePRO Solutions
Two key services that leverage technology to streamline and improve clinical trials are Electronic Data Capture (EDC) and Electronic Patient-Reported Outcomes (ePRO).
Electronic Data Capture (EDC)
System Selection and Implementation: CROs help clients choose the most suitable EDC system based on their specific needs and regulatory requirements. They also assist with implementation, configuration, and user training.
​
Data Entry and Management: CROs can handle data entry, ensuring accuracy and completeness. They also manage data quality, including data cleaning, validation, and query resolution.
​
Data Analysis and Reporting: CROs provide comprehensive data analysis services, generating reports and visualizations that help clients understand trial outcomes and make informed decisions.
​
Regulatory Compliance: CROs ensure that EDC systems and processes adhere to relevant regulations, such as Good Clinical Practice (GCP) and FDA guidelines.
​
Integration with Other Systems: CROs can integrate EDC systems with other clinical trial tools, such as electronic patient-reported outcomes (ePRO) systems, laboratory information management systems (LIMS), and clinical trial management systems (CTMS).
Electronic Patient-Reported Outcomes (ePRO)
Assessment: Identifying the most suitable ePRO system based on the specific requirements of the clinical trial.
System Configuration: Customizing the ePRO system to match the study's data collection needs.
Integration: Integrating the ePRO system with other systems used in the trial, such as Electronic Data Capture (EDC) and laboratory systems.
Training: Providing training to study staff and patients on how to use the ePRO system effectively.
Data Entry: Ensuring accurate and timely data entry by patients.
Data Validation: Implementing data validation rules to identify and correct errors.
Data Security: Protecting patient data privacy and confidentiality.
Data Backup and Recovery: Implementing measures to prevent data loss and ensure data recovery in case of emergencies.
Regulatory Guidance: Ensuring compliance with relevant regulations and guidelines for ePRO data collection and management.
Documentation: Maintaining appropriate documentation to support regulatory submissions.
Audits: Assisting with regulatory audits and inspections.
Patient Education: Providing patients with information about the importance of ePRO data and how to use the system effectively.