© 2018 Cobalt United

development strategy, design, and implementation of innovative technology solutions  

Cobalt Informatics

 

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 BIOMETRICS

 

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