Clinical data is a key deliverable from a clinical research study. To this end we have organized our Clinical monitoring and Data
Management groups to work together as a specialized Data Collection Team. The team’s goal is to provide clean data for analysis
in a timely and efficient manner.
Clinical Monitoring and Data Management
Data Management is an integral component of Clinimetrics' global capabilities. At Clinimetrics, we provide comprehensive data
management plans prior to study initiation, along with ongoing accurate reports in order to deliver quality study results and
reports.
Electronic Data Capture
Clinimetrics has coupled its clinical and data management groups together to take full advantage of the efficiencies offered by
Electronic Data Capture (EDC). We recognize the important impact that this technology has on the biopharmaceutical industry,
including highly efficient data collection and processing. EDC allows the investigational sites to electronically record data
directly into the clinical database, for availability to the sponsor once it has been reviewed for accuracy and completeness by
the clinical monitoring and data management staff.
State-of-the-Art Technology Platforms
We use Oracle™ Clinical database software, a validated clinical data management system, as well as SAS™ and S-Plus Analysis™
software. At Clinimetrics we combine state-of-the-art technology with professional expertise.
- Oracle™ Clinical (Web enabled)
- Oracle™ Clinical TMS (Thesaurus Management System)
- Oracle™ Clinical AERS (Adverse Event Reporting System)
- Oracle™ Clinical RDC (Remote Data Capture)
- SAS™
- MedDRA™, WHO Drug™
- InteractiveTrials™ Management System
- Device Tracking
Data Management services include:
- CRF design
- Database design
- Programming
- Data quality validation
- Query management
- Thesaurus coding/Lab data administration
- Study close-out/database lock
- Quality control and assurance (queries and data)
- Status reports (any format, including web-enabled secure access)
- Pre-planned and “ad hoc” summary reports
- Electronic data transfers
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