News

Publications

  • Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials. - Wu, G., Childress, S., Wang, Z., Roumaya, M., Stern, C. M., Dickens, C., & Wildfire, J. (2024). Therapeutic Innovation & Regulatory Science, 1-7.

  • Assessing the performance of methods for central statistical monitoring of a binary or continuous outcome in multi-center trials: A simulation study. Ge, L., Wang, Z., Liu, C. C., Childress, S., Wildfire, J., & Wu, G. (2024). Contemporary Clinical Trials, 107580.

Presentations

2023

  • 30k Secrets to Pre-Competitive Collaboration: Accelerating Open-source in Clinical Trials. Benedict, J. Wildfire, J. Presented at Fierce Clinical Summin, Philadelphia, PA. Sept, 2023.

2024

  • Good Statistical Monitoring {gsm}: An R Package for Risk-Based Moniotring and Clinical Trial Analytics. Wildfire, J. Roumaya, M. Presented at Phuse Connect in Washington DC. March, 2024.
  • Leveraging GitHub Actions and Continuous Integration in R Package Qualification. Roumaya, M. Stackhouse, M. Wildfire J. Presented at Phuse Connect in Washington DC. March, 2024.
  • Open-Source RBQM Software Development. Wildfire, J. Wu, G. Presented at BBSW, San Francisco, Ca. October 2024.

2025

  • OpenRBQM Extended: Endpoint Monitoring, Root-cause Analysis, and Workflows. Childress, S. Wildfire, J. Presented at Phuse US Connect, Orlando, Fla. March 2025. Slides. Paper
  • RBQM Workshop - Building Open-Source Tools paired with Central Monitoring Best Practice. Wildfire, J. Presented at Phuse US Connect, Orlando, Fla. March 2025. Website
  • {gsm.app}: Extensible Clinical Trial Monitoring Apps. Harmon, J. Wildfire J. Submitted for presentation at Shiny Conf, Virtual. April 2025. Abstract. Slides
  • Intro to {gsm.aesimrep} (title TBD). Koneswarakantha, B. Submitted for presentation at SCDM EMEA, Brussels, Belgium. April 2025.
  • Collaborative Industry Open Source Solutions for Clinical Trial Quality Management. Koneswarakantha, B. Submitted for presentation at Phuse CSS, Utrecht, the Netherlands. May 2025. Abstract. Slides.
  • Introducing {grail} an OpenRBQM R package for actioning RBQM Risk Signals. Maxwell, L. Submitted for presentation at UseR in Durham, NC. May 2025.
  • Title: Enhancing Risk Signal and Action Management with ML Prediction and AI-Driven Generation in Risk-Based Monitoring of Clinical Trial Data. Wang, Z. Submitted for presentation at JSM in Nashville, Tennessess. August 2025.