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Data Management & Biostatistics.

ERGOMED provides a full data management service through its partner Omega Mediation. Omega Mediation was founded in 1992 with different European locations. Data Management and Biostatistics is done by an long time experienced team in Offenbach, Germany, with the ACCESS-based Tracking and Logging System, a technology platforms that have set industry standards, The clinical data managers, data associates and database developers all have many years of experience in the pharmaceutical and life sciences industries. Omega Mediation is working with the database Clintrial.

The systems and software platform are fully validated to comply with international regulations, including FDA 21 CFR Part 11, and are supported by a full complement of IT SOPs.

Clinical Data Management services include:
• CRF Design
• Database Design
• Data Processing
• Medical Coding (using MedDRA and the WHO Drug Dictionary)
• Biostatistical Services