When you submit your paper, you will need to specify the submission section where you think your paper best fits. Here are the submission sections that have been defined for PharmaSUG 2025:

• Advanced Programming: Comprehensive explanations of sophisticated programming techniques, examples of solving programming problems, examples of specific programming solutions, integrations, and other innovative, high-level technical presentations geared for an audience of intermediate and advanced pharmaceutical and biotech industry programmers. (SAS, R, Python, and other languages/systems).

• Artificial Intelligence and Machine Learning: The section delves into the transformative role of AI and ML in advancing clinical studies and healthcare outcomes. It covers how these technologies are utilized for data analysis, predictive modeling, and personalized medicine, enabling researchers to uncover insights from vast datasets. The section also discusses ethical considerations, challenges in data quality, and the importance of regulatory compliance in implementing AI-driven solutions.

• Data Standards: Discussions of industry data standards such as CDISC CDASH/SDTM/ADaM, compliance, controlled terminology, versioning, implementation strategies and maintaining data quality, validation and acceptance, transparency and traceability, data exchange with partners and vendors, pilots and case studies.

• Data Visualization and Reporting: Explore techniques for creating graphs and tools for effective data visualization. Demonstrate how to apply new technology to better understand and communicate data effectively. Show how to present results to people of every technical level from critical stakeholders, medical personnel, and regulatory authorities to the general public. The techniques presented within this section can be used to better understand the data and improve decision-making in pharmaceutical and biotech industry development. Large and complicated data can be presented in an understandable way.

• e-Posters: e-Posters are focused on innovative topics and practical experiences presenting graphics, source code, statistics, thought-provoking concepts, novel data management, innovative ways to implement data standards, and much more. e-Posters are available throughout the conference and are ideal for displaying high-resolution graphics and presentations without requiring a formal lecture. There are scheduled times when authors are available to answer questions.

• Leadership and Professional Development: Discussions of issues facing programmers, statisticians, data scientists, consultants, executives and front-line supervisors in today’s pharmaceutical and biotech industries. Topics include work life balance, industry trends, interpersonal interactions, career development, leadership and mentoring by helping others develop and reach their full potential, consulting and contracting, networking techniques, recruiting and retention, dealing with global teams and the distributed model of working, or other relevant subjects.

• Metadata Management: The use of metadata within life sciences has increased over the years to support standards and process improvement. This section covers how metadata can be collected, managed, and used to deliver submission deliverables as well as support automation.

• Open Source Technologies, R, and Python: This section explores the powerful capabilities of open source software or tools in data analysis and statistical modeling in clinical research. It highlights the advantages of using open-source technologies such as R and Python, including their flexibility, community support, and extensive libraries. This section also covers popular open-source frameworks and tools that enhance productivity and collaboration in clinical research or data science projects.

• Real World Evidence and Big Data: Discussions about software tools, analytics, visualization, summary reporting, and data mining techniques in healthcare research areas that focus on real-world and big data such as patient-reported outcomes, patient/disease registries, risk evaluation and mitigation strategies, knowledge and behavior surveys, health claims, quality-of-life measurements, call center reports, electronic health records, prescription databases, FAERS/VAERS, and other real-world assessments.

• Solutions Development: Development, exploration, and demonstration of programs, system utilities, integration and productivity tools designed to assist the process of managing data and deliverables for clinical and observational trials. Including decisions, designs, and development process utilizing any programming language. (SAS, R, Python, and others).

• Statistics and Analytics: The implementation of statistical methods, advanced analytics, and innovative ideas to analyze and manage the data in our industry to report results from all phases of clinical trials (PK/PD, exposure-response modeling, pharmacogenetics, etc.), public health studies, and healthcare research. (SAS, R, Python, and others)

• Strategic Implementation: Business operations content dealing with new trends in in hardware and software for managing complex clinical trial programs, strategies for deploying new technologies, programming metrics, temporary workforce challenges, training methods and programs, and effective use of support resources such as technical support, discussion forums, user groups, social networking, and discussions with management to adopt new technology through implementation, training and staffing challenges.

• Submission Standards: Discussions of global submission industry standards, best practices and implementation strategies for deliverables such as Define-XML, SDRG, ADRG and eCTD folder content, the use of metadata repositories and other tools to automate submission documentation, submission experiences, pilots and case studies for regulatory submissions.

• Hands-On Training: Interactive training on a variety of topics that provides attendees with practical “hands-on” experience using industry software tools in a classroom setting taught by seasoned experts. Speakers are by invitation only.

• Water Cooler Chats: Discussions or conversations that are engaging and encompass a variety of topics from some of the papers selected in the conference or new topics. Attendees take a break to recharge from the formal presentations and socialize with subject matter experts in a casual manner. Water cooler chats are a great way to increase opportunities for collaboration at the conference. Speakers are by invitation only.