Electronic Data Capture [EDC]
Electronic Data Capture (EDC) has become an increasingly valuable tool in clinical research. PROMETRIKA is an experienced EDC service provider, currently providing comprehensive EDC services using several leading EDC platforms (Medidata RAVE®, Oracle® Clinical RDC, Oracle® Inform, Medrio eClinical, BioClinica Express, and DATATRAK eClinical®).
PROMETRIKA is a Medidata RAVE® Partner and conducts a number of phase 1 through 4 RAVE® studies for pharmaceutical companies as well as a leading international cancer institute. PROMETRIKA conducted a comprehensive standardization program creating standard eCRFs in Medidata RAVE® based on CDISC SDTM standards which are used for a variety of trials sponsored by a number of pharmaceutical companies.
Our comprehensive EDC services include:
- Study design and build using industry’s best practices – PROMETRIKA’s study build process includes comprehensive design specifications consistent with the sponsor specifications and CDISC standards, collaborative design review meetings, study-specific edit checks and listings development, test planning, optimal workflow configurations, batch data uploads, and site / user administration.
- User Acceptance Testing (UAT) – Data managers create test data and document results of screen review (field presence and labeling, code presence and accuracy, clarity of data entry instructions) and edit check testing (scenario testing of edit specifications). The UAT also verifies that the roles assigned in the EDC system function as intended and exports adhere to the specifications.
- Real-time browsing and summary reporting – PROMETRIKA’s EDC offering includes comprehensive reports, giving sponsors both real-time and summary views of existing data.
Streamlined data cleaning, validation, and locking – Edit checks and listings are programmed into the system, providing accurate and consistent data cleaning. PROMETRIKA provides customized workflow options to allow real-time data cleaning and locking at the form, visit, patient, or site level.
- Integration and/or validation of third-party electronic data – PROMETRIKA has extensive experience importing, integrating and validating electronic data from external sources in EDC trials (e.g., data from central clinical laboratories or core imaging laboratories).
- CDISC SDTM capable – PROMETRIKA’s EDC offering assures data exports that are as close as possible to SDTM standards, reducing the time needed for back-end SDTM conversion programming.
- Clinical monitor training and support – Data managers provide comprehensive training and support to monitors to ensure the workflow and system are easy to use. The data managers provide system entry compliance monitoring and trends analysis to maximize the efficiency of the monitors’ on-site visits.
- Site training and support – Data managers and clinical monitors provide study-specific data capture training and ongoing support to site personnel.
- Subject interactive devices – Through third-party vendors, subjects can be provided with hand-held devices for direct data entry into the EDC system. Similarly, interactive phone-in systems or study site terminals can be arranged.
PROMETRIKA has a comprehensive, collaborative eCRF building and testing process to ensure the eCRFs are ready within the study start-up timelines. A study EDC build usually takes six to ten weeks. PROMETRIKA Data Management and Database Programming services include:
- Design and drafting of the eCRF and eCRF Completion Guidelines
- Database design, development, and validation
- Data Management Plan development and maintenance
- Data review and validation
- Generation of queries and verification of resolved queries
- Generation of real-time metric reports and data listings (safety listings)
- Development and maintenance of protocol violations table within the EDC system
- EDC-based SAE collection, reconciliation, narratives, and MedWatch/CIOMS
- Web-based randomization and cohort management
- AE, medical history, signs and symptoms, and medication coding
- Third party electronic data integration and verification within the EDC system
- Legacy database integration
- Subject closure (freezing and locking data points, forms, visits, subjects, and sites)
- Providing eCRF submission-ready files
- Archiving of project documentation, testing, and study data files