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Data Management
We offer data cleaning and management techniques, demonstrated excellence in compliance and strong QC/QA functionality. Our in-depth knowledge of databases, combined with domain knowledge of medical terminology, thorough understanding of clinical study protocols and CRF design will prove priceless. Our proven ability to conduct extensive database testing, clinical data reviews and data clarification will provide insights into clinical data management.
In-depth understanding of patient profiles, SAE reconciliation, AE and CONMED coding are part of our product. Expertise in generation and resolution of queries derived from data discrepancies, extensive computer proficiency and understanding of computer technology provides an edge over the competition. Our systems are fully validated and compliant with ICH-GCP guidelines and 21 CFR Part 11. Following are the key features of our Data Management
Study Design and setup
SOP Training and Development
Data sampling
Listings and Graphs
CRF design
Query Management
Dictionary Coding (MedDRA, WHO-Drug)
CDISC data submission
Database creation
Data Export and Import
SAE Reconciliation Tables
(MedDRA, WHO-Drug)