Category: White Paper
Key Trends in U.S. Specialty Pharmacy
The Escalating U.S. Policy Environment
Innovative Financing for Novel Therapies
The Rise of Cost Effectiveness Considerations in the US
Implementing eCTD Through Outsourcing
Using Type 9 NDA Designation to Accelerate Multiple Approvals for Your Drug Product
Considerations for Managing Clinical Trials and Regulatory Filing Strategy During COVID-19
Regulatory Agencies across the world have quickly responded to the COVID-19 pandemic. Your approach to ongoing and new clinical trials and regulatory filing during COVID-19 requires adaptation and new strategies, such as following recommendations and using the fast-track COVID-19 programs recently instituted by Regulatory Agencies. In this white paper, we will focus on the reactions … Continued
Trial Simulator for NONMEM Modelers
Examples Guide Version 1 Applies to: Trial Simulator 2.3, NONMEM 7.3 As a courtesy to Certara’s Trial Simulator users, we have created this guide with 23 hypothetical examples where NONMEM codes and the corresponding TS codes are provided so that users may use these examples as templates to enter their models into Trial Simulator for … Continued