Klindat is a next-generation electronic Case Report Form (eCRF) for the pharmaceutical, biotech & medical device industries. It is a 100% cloud-based EDC for clinical trials, accessible from any Internet browser, without the need of installations. With a simple and intuitive design, the system is very easy to use, allowing an unlimited number of sites and users. The eCRF offers a great variety of clinical forms: diagnosis, pathology, clinical tests, treatments, medical evaluations, patient visits, concomitant medication, adverse events, and follow-ups, among others. All the forms and fields are customized according to the needs of each study. Customization includes logotype, access address (URL) and the colors of the visual interface. The solution integrates a complete hard edit check, automatic and manual queries mechanism, which ensures fast and efficient data cleaning, by detecting erroneous or incomplete fields. Edit check and automatic query conditions are customized. Each field has a button for source data verification (SDV)
and remote reviews that facilitate precise monitoring. The software is HIPAA compliant. Data security and integrity is guaranteed through an access control module. Access is limited to authorized users with individual passwords, and all connections and disconnections are registered in an auditable record. The tool causes automatic session disconnections after predefined inactivity periods and the blocking of user accounts after repeated unsuccessful access
attempts. Data are hosted in highly reliable servers, with constant backups, ensuring a continuity of service without interruptions.
- Data capture
- Data cleaning
- Clinical monitoring