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Future-Ready Clinical Trials: Embracing Pre-Trained AI for CDISC-Compliant Documentation


The number of clinical trials has been growing at an exponential rate over the last 2 decades. There were 10 times more trials in 2023 compared to 15 years ago. In parallel, GMP, CDISC, FDA and other organizations are continually evolving the GDP requirements to ensure trail efficacy and outcomes. 

For Sponsors and Contract Research Organizations (CROs), there's a surge in documentation that is unmanageable using traditional methods. Relying solely on manual human efforts to intake, format, classify, extract, and validate this data against the TMF standard has become impractical. These challenges compromise operational efficiency and can lead to significant business costs, including prolonged delays and potential FDA rejections.

Watch our panel of industry experts as they delve deep into:

  • The persistent industry challenges in clinical trial documentation and the reasons behind their perpetuation
  • The costly implications of manual documentation workflows, misclassified clinical data, and TMF non-compliance with CDISC
  • The importance of data completeness and auditability, and how AI-based solutions can ensure conformity to highest GMP, CDISC and FDA standards
  • The necessity of interoperability and seamless data workflows between DMS, CTMS, eTMF and RIM systems
  • The power of automation through a pre-trained AI model and how it can significantly expand trial management capabilities without increasing the team

Watch this session to equip your organization with the tools and knowledge to navigate documentation challenges more effectively and stay ahead in the competitive world of clinical trials.




Drawing on its training from thousands of clinical trial documents, this AI combines machine precision with human-like intelligence to categorize and extract vital data elements.

"We've put in thousands and thousands of pages to help the system get to a base understanding of the eTMF folder structure and the types of documents, but there are going be some unique differences potentially in your environment. As we keep adding thousands of pages, the system becomes that much more intelligent. As we get the human in the loop and they start correcting some of the low confidence values, the system is benefiting from that human interaction and learning over time."

- Anthony Vigliotti, CPO, Adlib Software.


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roger chan



Roger Chan | VP & Head of Clinical Data Management

Roger's extensive career spans over two decades in the pharmaceutical realm, including pivotal roles at FibroGen, Amgen, Allergan, Novartis, and Pfizer. His vast experience covers a range of therapeutic areas and global markets, showcasing his adaptability and expertise. Roger's journey has been marked by his dedication to revolutionizing data management practices, ensuring operational excellence and driving innovation in clinical trials. His leadership at major pharmaceutical companies has been instrumental in setting new standards for efficiency and efficacy in clinical research. Roger is set to share his invaluable insights, proven strategies, and a wealth of knowledge at our upcoming webinar, guiding attendees through the complexities of clinical data management and showcasing paths to success.




Keith Parent | President 
Court Square Group

Court Square has managed over 5,000 servers for global Life Science clients, including CTMS systems, Global Submission systems, eCTD systems, FDA Gateways, Adverse Event Reporting systems, as well as numerous Clinical Trial systems with 100,000+ users. With over 35 years of technology and leadership experience in the Life Science industry, Keith has a clear understanding of regulatory challenges and the Good System Practices (GSPs) required to maintain a Qualified state for the company’s clients. Keith has been a consultant to Pfizer for over 27 years and has held other leadership positions in the Life Science Industry.

Anthony Vigliotti



Anthony Vigliotti | Chief Product Officer 
Adlib Software

Anthony has 20+ years of experience in Business Workflow and Intelligent Document Processing segment with prior roles at Kofax, Nuance, Notable Solutions (NSi), and Xerox. Anthony brings a well-rounded set of experiences with solution-related roles in Product Management, Alliance and Partner Management, and Product Development. He holds a bachelor’s degree in Mechanical Engineering and a Master’s Degree in Information Technology, both from the Rochester Institute of Technology. In his spare time, he enjoys the outdoors with a good bike ride or hike, learning to play guitar, or wrenching on cars in the garage.