development strategy, design, and implementation of innovative technology solutions
Innovative Solutions to Total Data Privacy
Cobalt partners with companies that provide cutting edge innovative solutions to blockchain technology.
HOSPITAL IT INFRASTRUCTURE MANAGEMENT
CU's strengths include integrated healthcare systems with a hospital information management (HIM) solution for electronic medical records, patient, pharmacy and inventory management. Technical expertise includes IT Infrastructure, security, asset and application management.
Clinical Biometric Services include set-up of HIPAA-compliant, 21 CFR Part 11-compliant clinical trial data management databases and pharmacovigilance safety databases.
Data Management services include strategy, design, development and operation of databases for any stage of development including electronic data capture (EDC) programming and data analysis.
Biostatistics services include design specifications, protocol development and specifications, data analysis and reporting.
SAS programming services include creation of CDISC standard datasets including SDTM and ADaM datasets, table, figures and listings.
Provide complete infrastructure for biometrics implementation and validation, GXP compliance validation framework package.
Complete Infrastructure Management for RegOps including on-premise implementation of eCTD software
Provide managed services with cloud-based solutions with complete support for Regulatory software installation to implementation
IQ, OQ, PQ per 21 CFR Part 11
Technical troubleshooting and support
ICH Compliant eCTD Submissions