Pharmacovigilance

Minimizing adverse event management in a dynamic case processing workflow

Taking Samples

Today's Pharma companies face growing complexity in global regulations and increases in adverse event volume, all while adapting to changing technology of data sourcing.

 

This requires a different approach to Pharmacovigilance management; one which is automated, intelligent and outcome driven to improve product quality, optimize treatment plans, reduce costs, and improve patient safety.

Safety Challenges

Global AE case volumes are increasing 15-20% annually and doubling in the next few years, leading to increased workload and more potential errors.

Image by Thomas Jensen

Hiring more resources or investing in standard technologies will not solve your problem. 

Chemical works

Legacy PV systems cannot adapt to meet rising AE case volumes and the increased regulatory oversight.

Pharmacovigilance (PV) Solutions

Experience a new way to detect, assess, understand, and prevent adverse events with a fully-integrated, custom, end-to-end PV Software Application.

Pharmacist

Safety Case Intake

  • Adverse events case processing (AECP)

  • Multi-channel entry of safety case data

  • Automated ingestion via standard E2B format  

  • API (REST, SOAP, Custom) automated ingestion

  • Batch processing/delivery via import utility or sFTP

  • OCR capabilities to reduce manual data entry

  • Customizable context-based dynamic workflows

  • Full compliance reporting on intake process

  • 21 CFR Part-11 compliance and validation

  • Fully configurable to enhance performance

Safety Case Processing

  • Dynamic case processing workflow

  • Configurable AI rules for auto-coding

  • Industry standards - MedDRA, WHO drug, NDC, etc.

  • Auto-generated case narratives

  • Fully configurable templates

  • Ability to override/lock at the case level

  • Configurable business rules for reviews

  • Auto-generation of standard case reports 

  • CIOMS, MedWatch, E2B and eMDR

  • Reconciliation with external case data

Reportability - Submission - Insights

  • Configurable reporting rules by country and recipient

  • Reporting to Regulatory Agencies, Competent Authorities, Ethics Committees and Clinical Trial Investigators

  • Standard case types: SUSAR, SESAR, UADR, SAE, Line Listing and Annual Reports

  • Auto-generated templates and Cover Letters

  • Multi-channel package delivery: secure email, fax, portals, courier and hand delivery

  • Automated tracking and field-level auditing

  • Monitoring based on SLAs with escalation 

Contact Us

Learn more about our ability to innovate and deliver measurable value.

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Corporate Headquarters

855-751-5527