Electronic Data Capture – Clinical Research Data Management System (EDC-CRDMS)
Electronic Data Capture - Clinical Research Data Management System (EDC-CRDMS) supports the full life cycle of clinical studies from study inception, through data field/form, definitions/specifications, data entry, query resolution, data transfer and export, and study close-out.
EDC-CRDMS also streamlines the conduct of clinical trials within the Command while providing for greater visibility of the clinical trial process and simplifying the preparation of reports and publications. EDC-CRDMS is 21 CFR Part 11 compliant.
EDC-CRDMS is used by DHA R&D ORA, Walter Reed Army Institute of Research (WRAIR), United States Army Medical Research Institute of Infectious Diseases (USAMRIID), and Naval Medical Research Command (NMRC) for both clinical and non-clinical study data.
Features
- Creation of templates for Common Study Designs
- Reuse of Electronic Case Report Forms (eCRFs)
- Informed Consent
- Demographics
- Medical History
- Physical Examinations
- Vital Signs
- Labs
- Adverse Events
- Termination
- Coding with the Medical Dictionary for Regulated Activities (MedDRA)
- Coding with the World Health Organization (WHO) drug dictionary
- Adoption of Electronic Data Standards (CDISC)
- Customizable Reports
Training & Demos
A variety of training options and demos are available for EDC-CRDMS.
If you would like to schedule a demo or training, or have any questions, please contact us.