Versante provides comprehensive data management services for Phase I-II clinical trials. Our qualified team of Statisticians, CRF Designers, Database Programmers and Data Managers all work together in developing the Data Management Plan specific to your trial.
We have experience in working with paper-based data collection methods as well as with electronic data capture (EDC) systems.
Data Management Services Include:
Case Report Form (CRF and eCRF) design
Database design
Development of Data Management Plans
Development of edit check specifications
Development of CRF Guidelines documents
Data entry (if needed) and validation
Edit Check Programming
Query generation and resolution
Coding of adverse events (MedDRA)
Coding of concomitant medications (WHO)
Preparation of data for Data Safety Monitoring Board Meetings
Locking databases
Importing and exporting data
Providing databases that are CDISC compliant
Conversion of legacy datasets to meet CDISC Standards
Statistical Analysis and Reporting
Clinical Plan Development
Protocol Development and Study Design
Therapeutic Expertise Consultation
Data Management
Electronic Data Capture (EDC)
CDISC Conversion
Copyright © 2009 Versante International, LLC. All rights reserved. Legal Notices | Privacy Policy