Highlights
The client is a startup focused solely on developing a cutting-edge web application that automates the compliance checks for marketing materials in the pharmaceutical industry. Their primary sponsor is a major pharmaceutical company that required a faster, more efficient way to ensure that drug-related materials adhered to regulatory standards. The sponsor needed a solution that could reduce time, cost, and errors in the approval process of marketing materials.
Primary Objectives
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Automate Compliance Checks:
The startup’s goal was to create a system that automatically verifies whether marketing materials comply with regulatory requirements, reducing reliance on manual reviews.
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Reduce Time-to-Market for Pharmaceuticals:
By speeding up the review process, the startup aimed to help their sponsor bring drug products to market faster.
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Enhance Accuracy:
The solution needed to eliminate human error, ensuring that all necessary claims and rules were followed precisely.
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Support Collaborative Work:
The application required functionality for multiple users to collaborate on reviewing and editing the same document, while maintaining version control.
Challenge
How Academy SMART Helped
Business Impact
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Accelerated Compliance Review
The automated system dramatically reduced the time required for reviewing marketing materials, from several months to just days. The system also reduced the need for extensive legal reviews. This allowed the sponsor to move drug products to market more quickly, reducing delays and gaining a competitive edge.
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Elimination of Human Error
By automating the review process, the system minimized the risk of human errors, such as missing required disclaimers or overlooking regulatory guidelines. This increased the sponsor’s confidence in the accuracy of their marketing materials.
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Enhanced Collaboration
The platform’s collaborative features made it easy for teams across departments to work together on reviewing and editing materials. The built-in version control ensured that all stakeholders were working with the most up-to-date and compliant version of each document.
Summary
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