Clinical Data Management

IATEC uses eDM and eDataEntry for (electronic) data capture and data management. eDM, formerly known as DLB Recorder, is an Oracle-based Clinical Data Management System (CDMS) that provides a comprehensive solution for collecting, cleaning and managing clinical trial data in any development environment – from single-site to worldwide operations.

eData Management supports a variety of data entry strategies, from traditional double-key data entry to electronic data capture. Therefore, eData Management supports not only paper-based data capture but also electronic data capture using eData Entry, a comprehensive EDC application providing real-time access to patient data. The current implementation ensures a high-speed, high-capacity and scaleable IT infrastructure that is sized to meet both current and projected data volumes for all clinical trials. With the aid of these ‘end-to-end’ solutions we are able to accelerate your products’ time-to-market while ensuring superior quality and cost containment.

eDM is an industry-supplied software that is fully validated. Each new version of the software is delivered with a validation readiness Kit, which verifies that the process used to create, maintain, and support the software is validated. Each Kit provides information, supporting documentation, guidelines and test suites necessary to document internal systems’ quality assurance activities. Validation kits are consistent with industry understanding of FDA requirements and guidelines such as ISO 9000.

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	IATEC Clinical Trial Services Antiviral Research 1105 BM Amsterdam The Netherlands Phone: +31 (0)20 314 9300 Fax: +31 (0)20 314 9399 secretariat@iatec.com More information about IATEC at www.iatec.com