News & Events
May 16, 2019
Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials (May 16, 2019)This webinar provides an overview of the issues related to the use of paper backups in studies for which PRO data is collected electronically. Viable strategies to eliminate the necessity of a paper-backup system are provided. Presenters: Cindy Howry, MS (.assisTek) and Paul O’Donohoe, MSc (Medidata Solutions) PDF version...
- May 16, 2019
May 1, 2019 - May 3, 2019
2019 Annual INC Neonatal Scientific WorkshopMay 1-3, 2019 Hyatt Regency Bethesda, Maryland Meeting Objectives: Share regulatory perspectives on developing safe and effective therapies for neonates. Provide foundational knowledge on innovative, regulated medicines development and factors influencing Go/No-Go decisions throughout the development pipeline. Discuss endpoints for clinical trials to evaluate pain medications. Address neonatal opioid issues through optimizing trial design for......
April 24, 2019 - April 25, 2019
Tenth Annual Patient-Reported Outcome Consortium WorkshopApril 24 – 25, 2019 Sheraton Silver Spring Hotel 8777 Georgia Avenue Silver Spring, MD 20910 On April 24-25, 2019 the Tenth Annual Patient-Reported Outcome Consortium Workshop was held in Silver Spring, Maryland. The overall Workshop objectives were to: Provide an update on FDA’s Clinical Outcome Assessment (COA) Qualification Program and other initiatives; Describe new and emerging......
April 17, 2019 - April 18, 2019
2019 PSTC Japan Safety Biomarker ConferenceSummary With the cooperation and support of RIKEN, NIHS, JSOT and JPMA, the Predictive Safety Testing Consortium (PSTC) of the Critical Path Institute hosted the 2nd PSTC Japan Safety Biomarker Conference from April 17-18, 2019 in Yokohama, Japan. The utilization of biomarkers in guiding drug development decisions through clinical trials and post marketing studies is......