Pharmacovigilance
Case and Content Management
Case and Content Management
Case Management
Secure content storage
Cost Savings
Integrate with other systems
CARA – competitive advantages over traditional PV systems
- Large volumes of data (many TB) causes performance issues in maintaining documents in other PV systems – CARA provides high performance
- Data redundancy – multiple copies of same document kept in other PV systems due to the need of the same document that needs to be tied to multiple cases – CARA allows linking of content to multiple cases
- Costs – CARA provides a lower license cost option than other PV Systems
- CARA provides the central repository for maintaining and archiving documents in a validated system, missing from other PV systems
- CARA provides full integration with documents which are then used in submissions or other safety systems (whether based on CARA or not)
CARA / Content Management
- CARA is used for document initiation and sending over to the CARA Case Intake area
- CARA stores documents associated with cases for archival with better compression method.
- Processing of documents (such as redacting) is done in CARA using proper permissions and version controls.
- Medical Records, workflow checks, and validations built into the process
- Completed case information is updated in the CARA Case Management process and documents are moved into a completed folder.
- Automated QC process for moving input records to QC check folders
- Intake Worklist – Includes metadata around patient cases along with the file
- Metadata for cases include data points such as Country, Data, Product, Event
CARA / Case Management
- Patient cases are created in CARA using Case Management screens
- Document Intake area created to receive input files so files don’t have to be entered as part of a case
- Documents are added to either a new case or a follow up to an existing case
- Same document from CARA content store is used in multiple cases for faster processing times and increased in efficiency
- Cost savings from reduced licenses
- Full CARA security privileges on both content and cases, including granularity down to individual fields for country-specific data privacy
Single Point of Truth
- Partners USDM provide a VAP (Validation Accelerator Pack) for CARA
- Enables customers to meet industry regulations such as 21 CFR Part 11
- Single Point of Truth is maintained in CARA for regulatory purposes
- We provide additional project management / implementation services
Over 400,000 users and growing…
