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.
Join 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
Join us 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.