Industry
- Life Sciences
Patient-centered Care Models Taking Center Stage in Life Sciences
Highlights
- AstraZeneca partnered with TCS To streamline patient safety and regulatory process workflows across its regional centers.
- TCS’ workflow solution and integrated processes ensured real-time tracking of products across global delivery centers.
- The solution enabled AstraZeneca to streamline and standardize its patient safety and regulatory process workflows across seven regional centers.
In this article
In this article
Overview: Complying with regulatory standards
Being a multinational pharma major, AstraZeneca has to comply with various standards in the regions of its operations.
It aimed to meet the regulatory and safety standards through scientific excellence and effective global processes.
The challenge: Streamlining patient safety processes across regional centers
The company wanted to streamline and standardize all patient safety and regulatory process workflows across its seven regional centers.
It partnered with TCS to implement a solution that integrates safety and regulatory maintenance activities.
The solution: Integrated processes, end-to-end lifecycle maintenance
TCS integrated processes in patient safety and regulatory services and undertook end-to-end post-approval lifecycle maintenance and surveillance activities.
This was done for more than 70 established products and over 100 products in development, in over 130 countries for AstraZeneca. TCS’ workflow solution ensured real-time tracking of products across global delivery centers and employed more than 500 experienced pharmacists and physicians to form the safety-plus-regulatory teams.
The benefits: Streamlined workflow, regulatory compliance
TCS’ adverse event case processing operation was inspected by the Food and Drug Administration (FDA), US, Medicines and Healthcare products Regulatory Agency (MHRA), UK, and Swedish health authorities with no critical or major findings.
The TCS’ solution enabled AstraZeneca to streamline and standardize all patient safety and regulatory process workflows across its seven regional centers.
What Made it happen
TCS ADD™ is a suite of modern and open technology platforms for clinical research and drug development that helps make clinical trials more agile and safe.
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