RegDocs365

New Podcast Episode: Overcoming Challenges in Selecting CROs and Clinical Trial Vendors. https://lnkd.in/e3r_TxY5 Season 1 Episode 1: Keith Parent, CEO of Court Square Group discusses the importance of vendor management in life science with Kalyan Obalampalli (KO), CEO of ClinAI. KO shares his experience in managing $100 million in vendor contracts and the challenges of using Excel for RFPs and vendor comparisons. He highlights the benefits of ClinAI's platform, which streamlines vendor selection and management, providing analytics and data-driven decision-making. KO emphasizes the need for fit-for-purpose vendor selection, the importance of clear templates, and the potential of AI in predicting costs and ensuring fair vendor payments.  #podcast #AI #clinicaltrials #lifescience #pharma #biotech

New Podcast! Driving the Business of Science 🚀 https://lnkd.in/dm7G_33c Science alone isn’t enough to bring new therapies and devices to market. Success in pharma, biotech, and medical devices requires the right technology, processes, and partnerships at every stage.   That’s why we’re launching Driving the Business of Science—the podcast designed for clinical operations, IT, and business leaders navigating the complex world of life sciences.   Join host Keith Parent, serial life science CEO, as he speaks with industry leaders sharing real-world experiences and practical insights to help you stay ahead. #podcast #AI #clinicaltrials #lifescience #pharma #biotech

Bring Order to Your Rescue Trials with the Power of AI Court Square Group’s advanced AI-driven solution streamlines the rescue trial process by automatically classifying, cross-referencing, and integrating critical regulatory documents. Our tool ensures a seamless transition by bringing structure to the disorder, reducing stress, and saving valuable time and money. Learn more https://lnkd.in/eAEr35H6 Call (413) 746-0054 or email [email protected] #clinicaltrials #clinicaldata #ai  

Bring Order to Your Rescue Trials with the Power of AI Court Square Group’s advanced AI-driven solution streamlines the rescue trial process by automatically classifying, cross-referencing, and integrating critical regulatory documents. Our tool ensures a seamless transition by bringing structure to the disorder, reducing stress, and saving valuable time and money. Learn more https://lnkd.in/eAEr35H6 Call (413) 746-0054 or email [email protected] #clinicaltrials #clinicaldata #ai  

Can #AI Improve Clinical Operations? Yes. https://lnkd.in/dfv7qiAQ There are many ready-to-go AI solutions that can save you time and money and increase efficiency in your clinical operations. Court Square Group offers AI-powered tools for TMF Autoclassification, Intelligent search, M&A, Generative AI (RAG), Applications decommissioning, and more. Learn how AI can improve your clinical operations. Call (413) 746-0054 or email [email protected] #clinicaltrials #clinicaldata #ai #RAG

RSIDM Starts Today. Meet us at booth 200. Meet Court Square Group at #DIA's 2025 Regulatory Submissions, Information, and Document Management Forum #RSIDM, February 3-5, Bethesda, MD. https://lnkd.in/eQETrRuy Speak to Keith Parent, Rob Johnston, MBA, and Bryan Reynolds about the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)! #clinicaltrials #clinicaldata #ai #Quality #Validation #compliance #21cfrpart11

Let’s meet at DIA's 2025 Regulatory Submissions, Information, and Document Management Forum, February 3-5, Bethesda, MD. https://lnkd.in/eQETrRuy Meet Court Square Group and talk about the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)! #clinicaltrials #clinicaldata #ai #Quality #Validation #compliance #21cfrpart11

The US Food and Drug Administration (FDA) has issued the first guidance on the use of artificial intelligence (AI) for the development of drug and biological products.  The draft guidance provides recommendations on the use of AI to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality.  Specifically, it provides a risk-based credibility assessment framework that may be used for establishing and evaluating the credibility of an AI model for a particular context of use (COU).  The draft guidance is available now on the FDA website. Interested parties are invited to submit comments by 7 July 2025.  

Get a Fit for Purpose Content Repository https://lnkd.in/eKJF9TSz It is difficult for early-stage Life Science companies to find tools that are both right-sized and designed for Life Sciences. Meet Life Science LaunchPAD with RegDocs365 - A single, scalable repository that organizes, streamlines, and effectively manages your organization’s content and document needs. Learn how RegDocs365 and Life Science LaunchPAD, a Fit for Purpose solution, is cost-effective, scalable, and efficient through every stage of your growth. Request a demo. Call (413) 746-0054 or email [email protected] #21cfrpart11 #validation #qualified #compliance #clinicaltrials #clinicaldata #ai