HySynth Clinical Data Repository is used for storing, integrating ,managing and reporting on clinical studies.
It enables pooling of clinical and nonclinical data from multiple sources into a single environment. Better regulatory compliance with comprehensive security, an audit trail, and traceability, More-informed decision-making through pooling and analysis of clinical and nonclinical data
CDR has been developed to revolutionize ability to:
- Address complex health authority questions quickly and completely
- Produce CDISC compliant submissions
- Review safety data in real-time, mine our overall database for scientific and commercial queries
At HySynth provide,
- Business case development and cost analysis
- Requirements and design management
- Best practice analysis and recommendations
- Installation and configuration
- Oracle CDA and LSH pilots and proofs of concept
- Hosting
- Oracle CDA and LSH implementation
- CDA and LSH validation
- CDA and LSH training
- CDA and LSH extension development
LST on the following applications
- Argus Safety Suite
- Oracle Clinical / Remote Data Capture (RDC) /
- Thesaurus Management System (TMS)
- Oracle Inform EDC / Central Designer / Central Coding
- Life Sciences Data Hub (LSH)
- Oracle Data Management Workbench (DMW)
- Oracle Clinical Development Analytics (CDA)
- Adverse Event Reporting System (AERS)
- SAS
10. HySynth BioTechnologies
• CDR is used for storing, integrating ,managing and reporting on clinical
studies.
• It enables pooling of clinical and nonclinical data from multiple sources into
a single environment.
• Better regulatory compliance with comprehensive security, an audit trail,
and traceability
• More‐informed decision‐making through pooling and analysis of clinical
and nonclinical data
• CDR has been developed to revolutionize ability to:
• Address complex health authority questions quickly and completely
• Produce CDISC compliant submissions
• Review safety data in real‐time, mine our overall database for
scientific and commercial queries
Clinical Data Repository (CDR)
14. HySynth BioTechnologies
The CDR system extracts data from both the structured and
unstructured datasets.
Structured data sources ‐ CRO Data, EDC Data, Safety data,
AERS data, Prescription Data, Patient Data, Purchased Trial
data, Dictionary Data and Coding Systems.
Unstructured datasets ‐ the documents such as IVRS.
The Source System Interface Architecture Component
manages the extraction, verification and integration of
“changed data” from the Source System into the “Interface
Design Framework” and facilitates its transfer to the Data
Staging Subcomponent.
Data Sources
Data
Sources
26. HySynth BioTechnologies
Maintenance and Support
confidential
• Help business for Troubleshooting functional issues
• Application maintenance
• Administration of OC/RDC/TMS, Argus, Inform, LSH, CDA, DMW and Oracle Database.
• Regular health checkups
• Applying bug and security Pâtés
• Troubleshooting and fixing technical issues
With multiple support channels:
• Live phone
• E‐mail
• Remote Access
• Knowledge base