Synterex Blog

The U.S. Food and Drug Administration's (FDA) draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, offers a comprehensive framework for the integration of artificial intelligence (AI) in drug development. For regulatory professionals, understanding the various engagement options beyond traditional FDA meetings is crucial for effectively navigating AI applications in clinical trials.

Artificial Intelligence (AI) is revolutionizing the field of cancer immunotherapy by accelerating the discovery, development, and delivery of innovative treatments. Here is a breakdown of its potential role: Drug Discovery: AI algorithms can analyze vast amounts of genomic, proteomic, and clinical data to identify potential drug targets and predict the efficacy of immunotherapies.

As clinical trials evolve in the digital age, e-consent has emerged as a promising tool to enhance patient engagement, streamline processes, and improve regulatory compliance. While the benefits of e-consent are significant, implementing this technology also presents several challenges that sponsors and clinical teams must navigate.

Establishing early alignment with the FDA on the rolling submission approach is pivotal to your success. Before you initiate any submission activities, ensure you have secured the FDA's agreement on both the timing and the scope of your rolling submission.

<p>When pursuing a Biologics License Application (BLA) or New Drug Application (NDA), meeting timelines is crucial. However, the path to approval is often fraught with potential delays. Understanding these risks—and knowing how to mitigate them—can make or break your timeline. Top 10 most common risks and expert tips on how to manage them effectively 1.&hellip;</p>

In the fast-evolving biopharmaceutical industry, the integration of artificial intelligence (AI) into clinical documentation processes presents an unprecedented opportunity to enhance efficiency and accuracy across the entire value chain. By adopting a technology-agnostic AI system, biopharma companies can significantly streamline operations, reduce costs, and accelerate drug development, ultimately delivering innovative therapies to patients more quickly.

In today’s rapid digital transformation of the clinical trials space, artificial intelligence (AI) is becoming an indispensable part of meeting business goals and improving patient care and treatment.

Introduction In the rapidly evolving landscape of healthcare, artificial intelligence (AI) is transforming the way clinical documentation is managed. As biotech and pharmaceutical companies, academic institutions, and healthcare systems increasingly adopt AI tools to improve the accuracy and efficiency of clinical information, the need for robust governance structures becomes imperative.

Toward the end of clinical document development, a quality control (QC) review is needed to verify data, check facts, ensure structure is internally logical and meets regulatory requirements, and proofread for typographical errors or inconsistencies.

Prepare for a successful Quality Control review! Download this poster, presented by Synterex at the 2023 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version.