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#FutureReadyHealthcare
Global Biopharma Leverages Generative AI to Develop Informed Consent Forms and Plain Language Protocol Synopsis​
The Need
The customer was desirous of leveraging Generative AI solution to create Informed Consent Forms (ICF) and Plain Language Protocol Synopsis (PLPS).
Indegene Solution
Indegene established an innovation hub for leveraging Generative AI to generate lay language from complex clinical protocols. The team:
Streamlined the creation of lay summaries, enhancing transparency and understanding for non-specialist audiences
Automated the Protocol to ICF conversion process ensuring that ICFs were both compliant and easily understood by patients​
Enabled efficient comparison, summarization, and mapping of global protocols to country-specific requirements, ensuring compliance with local regulations and speeding up the approval process​
Outcomes
Automating document preparation with Generative AI significantly reduced manual effort, allowing the customer to focus more on strategic activities and enhancing overall productivity
Standardized processes for lay language generation and protocol summarization ensured adherence to complex regulatory requirements across multiple regions, reducing the risk of delays and penalties​
The implementation of Generative AI positioned the company as a leader in the use of advanced technologies for regulatory compliance and patient communication, potentially enhancing its reputation with regulators, patients, and stakeholders​
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