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Data Management & Biometrics
Systems & Technology |
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Covance has invested in industry-leading data management technology and has implemented it consistently around the world. Through consistent technology, we manage clinical data for a new drug, from Phase I through Phase IV, in the same system, adhering to consistent data standards.
The results are combinable, fully-integrated clinical and laboratory data across an entire regulatory submission. In addition, the global consistency in systems yields the highest degree of quality and process efficiency.
Our technology includes:
Oracle Clinical v4.03. Oracle Clinical has been adopted as the standardized platform from Phase I through to Phase IV. The system is deployed globally, with centralized database servers accessible from all data management centers, allowing us to coordinate data from large international trials within a single study database.
Integic® CRF Imaging System. This system allows Covance to closely manage and coordinate studies and global resources to ensure deadlines are achieved. The system is integrated with Oracle Clinical, and enables the acquisition of data from faxed and/or scanned CRFs using optical character/mark recognition or manual data entry from the images. This allows a paperless system: Our staff members work with images rather than paper CRFs.
Direct Access Solutions. Covance has a wealth of experience with direct connection into sponsors' clinical data management systems. This access ensures that processes and standards are followed, while the sponsor maintains control over data. Covance has worked with more than 10 different sponsor companies and more than 60 global Phase II to IV studies in the last 5 years alone.
Electronic Data Capture (EDC). Covance has relationships with most of the industry EDC vendors. We offer clients flexible options for EDC tool selection based on systems' features and/or client preference. Our approach to EDC means that we support your system of choice or we can recommend systems that will meet your study needs.
eDiaries/ePRO. Covance has relationships with many eDiaries and other eRO vendors. However, we offer a vendor-independent approach to these technologies so that we can advise you on the best approach for a study.
Direct Data Retieval — CODAQ. For those programs not suited to an EDC approach, Covance offers alternative methods that reap the EDC benefits. For example, soon after patient visits have occurred, Covance can retrieve data independent of a monitoring visit.
Clinical Trial Portals. Covance can design and provide Web-based portals that allow study teams to view, query and generate reports on all data derived by Covance, including graphical summary and review of safety and enrollment data. |
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