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Pharmacovigilance
Case and Content Management

Case Management

Case Management

Case intake, review and management, including E2B R3 capabilities

Secure content storage

Secure content storage

Leverage the scalability and security of CARA for storing Serious Adverse Event (SAE) documents associated with cases

Cost Savings

Cost Savings

From reduced licensing, consolidated (regional) case processing, reduced resource needs, and deduplication of records.

Integrate with other systems

Integrate with other systems

Integration points with other Safety or Regulatory systems to exchange content and data

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…

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