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Conference

PSI 2025 Conference

Conference: PSI 2025

Date: June 8-11

Location: Wembley Stadium, London, UK

Booth: #13

Certara is proud to return as a Gold Sponsor of this event and to support the mission of Statisticans in the Pharmaceutical Industry (PSI).

Learn about Generative AI tools for statisitical analysis plans (SAPs)

Medical writers are using Certara’s CoAuthor GenAI software to gain efficiences and transform the process of drafting regulatory documents. The same technology is here to help biostatisticians achieve time savings of 40-50% when drafting SAPs.

Stop and see us at PSI (booth #13) to hear more about how GenAI can not only speed up SAP writing but also increase quality by alerting you to applicable guidelines and recommending methodologies based on similiar study objectives.

CoAuthor speeds up the SAP writing process by:

  • Extracting relevant information from the protocol (objective, endpoints, study design, and preliminary statistical selection) and incorporating it into the SAP template
  • Alerting biostatisticians of potential requirements among applicable regulatory guidelines
  • Suggesting methodology that’s used for the analysis of endpoints with similar study objectives
  • Generating related output templates (tables, listings and figures) along with their programming code for production

Advanced biostatistics consulting and CDISC-compliant statistical programming

Clinical trial data is the foundation of drug development, and a poorly designed study can jeopardize even the most promising therapies. Certara’s expert biostatistics consulting team ensures high-quality data collection, validation, and analysis, enabling smarter decisoins and reducing risks. With comprehensive support across all phases of drug development, we can help you conduct efficient and cost-effective trials in a way that increases the odds of regulatory approval.

Additional Resources