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What we achieved

  • Cloud native solution

  • Modernized UX for collaboration and onboarding

  • Real-time change management

To who

Overview

  • Part 1

    Challenge

    Third-party solution costly to maintain, unsupportive of all communication channels with lack of visibility to REMS Registry processes.
  • Part 2

    Solution

    Modern platform with the ability to track progress, eliminating manual processes, and real-time updates.
  • Part 3

    Results

    Cloud native solution with a modernized UX adhering to FDA (Food and Drug Administration) requirements and provides dynamic dashboards for reporting.

The Challenge

Business challenge story

A multi-billion-dollar biopharmaceutical company was looking to modernize their REMS (Risk Evaluation and Mitigation Strategies) registry solution. They were utilizing a third-party solution that was costly to maintain and didn’t support all their communication channels. There was an inability to track progress; REMS Registry admins had no end-to-end visibility across various REMS registry processes including tracking non-compliance and wholesalers/distributors registration. There were several manual processes making it difficult to adhere to strict regulation and compliance requirements from the FDA.

The Solution

Transformation story

HCL’s Digital Experience Manager offers a cloud native solution enabling TCO (Total Cost of Ownership) and faster time to market for the biopharmaceutical company. They are gaining a modernized UX enabling better collaboration and ease of onboarding for internal stakeholders and digital validation to automate the REMS registry process for external stakeholders. HCL DX Manager pulls in the data to provide tracking ability and assists in managing audit trail reporting to take correct actions accordingly and ensures compliance with FDA regulations.

The Results

Results story

For this biopharmaceutical company, the results are all positive. With HCL DX Manager, they’re able to meet FDA requirements by providing audit controls for governance, compliance, and reporting. Dynamic dashboards provide reporting capability that allows early identification of actions. They are empowered with real-time change management capabilities, removing the reliance on others and giving them full ownership and control. They are traversing forward into progress with removal of manual processes, cost efficiency, and accountability by partnering with HCL Digital Experience.

About the company

This is a leading fully-integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Working across 100 countries, they offer a deep understanding of patient and physician behaviors and market dynamics. They share insights, use the latest technologies and apply advanced business practices to speed customers’ delivery of important therapies to patients.

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