Services and solutions we provide
Data management
Dr. Amos Ndhere MD, MS2024-01-25T12:08:18+00:00QUALITY DATA FOR BETTER OUTCOMES Comprehensive CDM Compliance Meeting Regulatory and Industry Standards such as CDISC& CDASH, 21 CRF Part 11, ICH E2A, GDP, and HIPAA CONTACT US RIGHT DATA FOR EXPEDITED PRODUCT REGISTRATION Our CDM experts work closely with clinical trial teams to collect complete, accurate, and free from inconsistencies, which helps to boost confidence of stringent regulatory agencies and secure marketing authorization. eCRF design SAP Development Statistical Analysis TLFs ADaM / SDTM Standards Consulting Database development and testing Data entry and tracking Database closeout and archiving activities. Discrepancy management External data reconciliation Medical coding Lab safety data and Biomarker data management. With our CDM services, you can be assured of high-quality data to support regulatory submissions for marketing applications for your new [...]