Clinimetrics offers EDC services utilizing the Oracle™ Clinical Remote Data Capture (RDC). Our validated, 21 CFR Part 11
compliant, installation is a complete clinical data management solution. Clinimetrics provides access for live, secure entry
of clinical trial data directly into the database; no data transfer uploads from the clinical sites are necessary.
EDC is a web-enabled process that saves valuable drug development time by streamlining the data validation process and
automating query resolution. Oracle™ Clinical RDC allows the real-time validation of patient data for the investigative
sites and interactive discrepancy management. EDC has been shown to reduce queries and decrease the time needed to lock the
clinical database.
In addition to digital signatures inherent in Oracle™ Clinical, Clinimetrics employs digital certificates to ensure that only
authorized personnel using approved and appropriately configured computers have access to the system.
Benefits of working with Clinimetrics’ staff and EDC system for your clinical trials, vs. the traditional paper-based Case Report Form data flow:
- Reduction in the time from last patient, last visit, to database lock
The EDC system virtually eliminates dependence on couriers, fax machines and email for the processing of clinical trial data and the resolution of data discrepancies.
- Streamlined Discrepancy Management
Virtually all queries related to missing fields and data-type errors can be avoided. Also, the electronic representation of a case report form has color-coding to indicate the discrepancy status.
- Minimization of paper-based storage needs, printing, and photocopying
The on-site space required to store Case Report Form binders can be eliminated.
- Immediate feedback to study coordinators at investigative sites
Feedback is provided immediately to the study coordinators, while the patient charts are still easily accessible. In addition, Sponsors and CROs can use the system to broadcast messages to each investigative site, for purposes of training and information sharing.
- Facilitation and tracking of monitoring and investigator review activities
The system allows various levels of access privileges for investigators, monitors and coordinators. All activities related to source data verification (SDV) and investigator review of the data can be facilitated and tracked within the system.
- Online clinical data management status reports available
Monitors and site coordinators can access reports containing information related to missing pages, outstanding discrepancies, pages awaiting SDV, projected visits, etc.
- Experienced staff available to provide set-up and support during the conduct of the trial
Clinimetrics Project Management and Clinical Research Associate staff have been managing and supporting electronic data capture trials for years, while the Data Management staff has been working with the Oracle™ Clinical system as a database since the department’s inception.
Download a printable brochure: "Electronic Data Capture"
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