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.

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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.

Our Solution

Experience a new way to manage Pharmacovigilance with a fully-integrated, custom, end-to-end PV Software Application.

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PV-SECURE™

Safety Case

Intake

Safety Case 

Processing

Reportabilty-

Submission Insights

PV-SECURE

A solution that ensures your data is clean, healthy, and uninterrupted at every stage.

  • Adverse events case processing (AECP) leveraging automated and configurable business rules

  • Multi-channel entry of safety case data

  • Delivered in a 21 CFR Part-11 compliant, validated environment to meet increasingly complex regulatory environment

    • Automated ingestion via standard E2B format  

    • API (REST, SOAP, Custom) automated ingestion

    • Batch imports  / OCR capabilities to reduce manual data entry

  • Customizable context-based dynamic workflows to  enhance performance

  • Portal access to give visibility to Investigators and sponsors into safety profile of an investigational product throughout its lifecycle 

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PV-SECURE

Get management insights on demand

Automated reporting for complex global regulations, increased AE event volume and rapidly growing sources of data including:

  • Configurable reporting rules by country and recipient

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

  • 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

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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

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Automated, intelligent workflow, to improve the pharmacovigilance function

Contact Us

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

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Corporate Headquarters

855-751-5527