Data Management

We develop secure databases for both paper-based CRFs and electronic CRFs (e-CRFs), with web access compliant with 21 CFR Part 11 regulations. Our databases are designed to ensure the security, integrity, and confidentiality of clinical data.

Additionally, we create detailed Data Validation Documents (DVDs) that guide all validation procedures. These documents include test plans, validation scripts, and compliance reports, ensuring that all data is accurate, complete, and compliant with regulatory requirements.

Our CRF processing services include detailed annotation of forms to guide the data entry process and ensure clear, accurate data collection. We efficiently manage the receipt of paper-based CRFs, tracking, and data entry, using rigorous double data entry processes to validate accuracy.

Our team is trained to quickly identify and resolve any inconsistencies or errors in the data, ensuring that the information collected is reliable and ready for statistical analysis.

Ensure precise coding and data reconciliation to maintain integrity throughout the project.

These systems allow for the consistent classification and coding of medical information, facilitating data analysis and comparison. Additionally, we effectively integrate external data sources into the main database, enhancing the robustness and completeness of the collected information. The reconciliation of pharmacovigilance and clinical data ensures that all adverse events are accurately recorded and reported in compliance with regulatory standards.