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ClinAccess™ Clinical Data Management System
ClinAccess™ 5.1 is the next generation of our industry leading Clinical Data Management System based entirely on SAS® 9. It leads the way in simplifying clinical data management, clinical trial analysis and preparation of electronic submissions. Having your data keyed directly into SAS® data sets enhances your staff’s productivity by eliminating the time spent transfering data from Oracle/SQL into SAS. ClinAccess™ is designed expressly for ease-of-use study definition, data entry and management with features to monitor the progress and quality of ongoing clinical trials. Whether for review, analysis, or FDA submission, your data is always in SAS®and ready for analysis. The database structure is designed to support and accelerate statistical analysis and reporting. The result is less time and effort for data analysis and a shorter time to market. For reliability, auditing and security, there is no better solution than ClinAccess™.
Additionally, our system provides a highly affordable return on investment. By requiring very little IT Infrastructure and no exclusive database administrator, you can devote fewer resources to Clinical Data Management System maintenance and concentrate on what you do best, bringing drugs to market. The result is that ClinAccess™ allows you to achieve your clinical trial goals faster, with greater ease at lower cost.
Features of the ClinAccess™5.1 integrated solution include:
- Rapid Study Definition via User Friendly Wizards
- Sixteen Types of Data Entry (including Double-Key Entry and a complete Audit Trail).
- Electronic Data Capture
- CRF Imaging
- Forms Control
- Query Capture, Reporting, and Resolution
- Dictionary Coding of Adverse Events (AEs) & Medical Terms
- Clinical Data Review Tools
- 21 CFR Part 11 and CDISC Compliant
- Prepares Data and CRF Images to FDA e-Submission Standards
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