Data Management
Encorium’s Data Management experience extends from phase I through to large phase III and IV trials (>61,000 subjects).
Our Data Management group consists of more than 60 experienced Data Entry Operators, Data Managers, Medical Coders, Programmers and Database and Case Report Form Designers located in our offices in Estonia, Finland, Turkey and USA.
Our Data Management group is powered by a complementary suite of the latest industry-leading technologies, including Oracle® Clinical, Clintrial™, DataFax™, and various electronic data capture (EDC) systems. Whether your needs are paper-based, electronic, or a combination of the two, our data management systems conform with accepted industry standards and have been subjected to rigorous documented system validation and acceptance tests to meet regulatory requirements.
We develop in-house systems tailored to the clients' needs including, small scale web-based EDC systems, web-based questionnaires, web-based CRF tracking system and emergency envelopes for randomized studies and Interactive Voice Response System (IVRS).
Our IT staff continually monitors our technology infrastructure, allowing us to transfer data management activities between locations. All database applications are fully validated and in compliance with 21 CFR Part 11 regulations. Our staff works to the highest standards by following Good Clinical Data Management Practices (GCDMP) and we are also compliant with CDISC standards.
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