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New Drug Application (NDA) Submissions 505(b)(1) Or 505(b)(2)

There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough.

Uncovering the Hidden Insights in Clinical Trial Documents: Critical Steps to Intelligent Document Processing

In clinical trials, pharmaceutical companies are seeking to optimize operations and improve efficiency by automating and enhancing processes through Artificial Intelligence (AI) and Machine Learning (ML). One area where this can reap tangible benefits across clinical trials is in data processing. A typical clinical trial generates over 13,000 documents in various formats (text, voice, video, apps, and web entries), making data gathering, organization and analysis challenging. It’s here that implementing automated Intelligent Document Processing (IDP) can significantly benefit clinical trials, boosting productivity, speeding up processes, improving accuracy and delivering cost savings. IDP uses AI and ML to process structured and unstructured documents, allowing technology to read and understand content like a human, This article outlines the steps to implementing IDP in clinical trials’ digital content flow using transformative technologies like digital twinning, AI/ML, na

eCTD 4 0 is changing the regulatory landscape – what you need to know

eCTD 4 0 is changing the regulatory landscape – what you need to know
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LEXISNEXIS® REED TECH EXPANDS PORTFOLIO TO OFFER ELECTRONIC COMMON TECHNICAL DOCUMENT SUBMISSION PUBLISHING SERVICES

LEXISNEXIS® REED TECH EXPANDS PORTFOLIO TO OFFER ELECTRONIC COMMON TECHNICAL DOCUMENT SUBMISSION PUBLISHING SERVICES
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