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PHARMACOVIGILANCE

Pharmacovigilance (from "pharmakon" and "vigilare"), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

Pega PV Framework

Improve speed, compliance and risk management for drug and device safety.

Pega Pharmacovigilance is a ready-to-use solution that, by streamlining case processing, providing case tracking, reducing duplicate activities, and automating tedious tasks, allows for up to 50% reduction in case processing time. The solution can be configured with minimal effort. And, thanks to Pega's low-code approach, the solution can also be further extended in record time. 

 

Create new or follow-up cases

 

You have the option to create new or follow-up case. If you select follow-up case, then data from the previous case is copied over.

 

Capture product information using intuitive product search UI

 

Supports different industry standard Product data models to search data from different data sources from a single UI

Drug role characterization and identification

 

Identify the drug details, using various data entry fields and, on the same screen, identify also the dosage and indication information

Capture adverse event using MedDRA codes

 

Search UI provides ease of browsing through MedDRA catalog. Alternatively, identify adverse event by providing Verbatim in the comments field

 

Adverse event questionnaire

 

Capture important adverse event information using dynamic questionnaire form which can be easily configured using Pega Survey capabilities

Other benefits include:

  • Classification of the adverse event: The provided logic can be configured, for example: to auto-classify the assessment as serious case, when the patient has been hospitalized. Authorized users have the option to override some of the generated outcomes, with an audit entry automatically capturing what was modified, when, and by whom.
     

  • Duplicate check support: Application can automatically find duplicate cases to improve data quality and reduce manual interventions. Intake users can preview existing cases and take appropriate action.
     

  • Auto-narrative: application auto-generates narrative from the case data, when auditors wants to quickly review the case details.
     

  • CFR Part 11 audit & reauthentication: Several screens in the application are configured to trigger the CFR part 11 audit (previous and new value) and re-authentication of the user. This can be further extend into other existing or new screens.
     

  • Mapping MedWatch to E2B R3 data: Step-by-step user interface where user can simply upload a MedWatch form (PDF). Data is presented in the MedWatch format, allowing easy comparisons with the original. It also converts it to E2B R3 data model.
     

  • Medical and Quality reviews: The application is configured to automatically route cases to Medical review specialist (MRS) or Quality review specialist (QRS) when certain conditions are met. This improves the overall quality of data by identifying potential errors and correcting the data.
     

  • Bulk editing cases: Bulk edit interface where multiple cases can be updated in bulk, while preserving the audit entries. This is specialy helpful for quick updates to common details, for reassigning multiple cases to a different user, for adding notes to selected cases, or for just withdrawing cases.

Pega PV Outbound Module

Aditional benefits for large pharma companies with the outbound module:

  • Automates the global distribution of safety reports and submissions to affiliates, business partners, regulators, and other interested parties

  • Supports a variety of integration methods to retrieve incoming safety data from various sources

  • Automatically delivers approved submissions to a submissions management system for pickup and delivery

  • Supports monitoring of response files from external submissions management systems

  • Route case details as well as reports to affiliates/business partners based on country or region for review and update

  • Can support any scenario form a single partner managing a single product for single country, all the way to complex multi-region/multi-product agreements

  • Full auditability is always provided, even if partner mappings change over time

  • Generates regulatory reports for distribution to regional regulatory agencies

  • When certain conditions are met, the application can auto resolve the cases, without needing manual reviews

  • SLA’s can easily be extended further to match those of your organization

  • Comes with pre-configured PDF templates for standard FDA 3500A (MedWatch) and CIOMS PDF reports

  • The PVX module helps ensure regulatory compliance, and monitoring functionality, and prevents duplication of pharmacovigilance activities by various partners

HOW CAN WE SOLVE BUSINESS CHALLENGES
AT THE SPEED OF STARTUPS?

Innovation Sprint: 2-week collaboration to discover more and reduce risks at a low cost!

At the end of this 2-week collaboration you get:

  • Business Outcomes - Business outcomes mapped to current pain points, and journeys KPIs, allows to continuously track progress on value delivery

  • Solution Prototype- User-tested demo of possible features, directly captured in Pega. Validates ideas and assumptions. And it can be reused for the final solution

  • Product Backlog - Translates the product vision into a backlog if work, allowing to estimate delivery and total cost of ownership

  • Delivey Approach- Flexible model to fast-track delivery, enable internal teams, and accelerate overall return on investment

  • Effort Estimates  - Weighted Agile estimation of effort for the MLP, and for the overall program, also enables decisions on investment priorities

  • Program Roadmap - Iterative plan to rollout the solution. Allows incremental  delivery, learning cycles to further improve the solution, and review of investment priorities

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