Data management
Neuvantics provides data management services that are essential for ensuring the accuracy, integrity, and compliance of clinical trial data throughout the research process. These services help to manage and streamline data collection, validation, analysis, and reporting, ensuring that the final data is reliable and ready for regulatory submission.
Neuvantics also implement risk-based monitoring (RBM), which focuses on identifying and managing high-risk areas of a trial to ensure data quality and reduce costs. eClinical solutions, such as Electronic Data Capture (EDC), ePRO, eConsent, and RTSM, are deployed for real-time data management across multiple sites. We assist with interim analysis, providing critical support in analyzing data at key points during the trial. Data visualization tools enable sponsors and stakeholders to easily assess study progress and make data-driven decisions. Furthermore, we provide audit and inspection support, ensuring that trial data is organized and compliant with regulatory standards during external audits.
Our Data Management services include:
- Design of Case Report Forms (eCRF) in collaboration with Clinical and Biostatistics teams
- Development and implementation of database systems
- Validation, review, cleaning, and management of data queries
- Medical coding using MedDRA and WHO Drug standards
- Complete management and reconciliation of data from third-party electronic data providers
- EDC Help Desk support for troubleshooting and user assistance
- Collection, consolidation and conversion of data, adhering to CDASH and CDISC standards
- Safety management and Serious Adverse Event (SAE) reconciliation