What is a Global Risk Mitigation Plan & how can you use it to ensure a successful drug launch? Blog What is a Global Risk Mitigation Plan & how can you use it to ensure a successful drug launch? A Global Risk Mitigation Plan (GRMP) is a critical step in drug development as it…CertaraMay 4, 2023
FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers Press Coverage FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project…CertaraMay 3, 2023
How digital communication tools will revolutionize your medical conversation On-Demand Webinar How digital communication tools will revolutionize your medical conversation Medical Affair, Market Access, and Sales & Marketing teams at most of pharmaceutical companies use…CertaraApril 24, 2023
Innovating Sales & Marketing Digital Engagement for Pharma and Med Tech Blog Innovating Sales & Marketing Digital Engagement for Pharma and Med Tech The regulatory environment for Pharma and Med Tech creates business challenges for digital engagement. Many…CertaraApril 21, 2023
Transforming Trial Success: AI’s Role in Clinical Trial Meta-Analysis On-Demand Webinar Transforming Trial Success: AI’s Role in Clinical Trial Meta-Analysis Published research and literature-based content holds valuable insight that can inform clinical trial execution and…CertaraApril 19, 2023
Antibody-drug Conjugates in the Clinic: Key Considerations & the Role of Modeling in Expediting Development On-Demand Webinar Antibody-drug Conjugates in the Clinic: Key Considerations & the Role of Modeling in Expediting Development Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a…CertaraApril 17, 2023
Stepwise PIPs: A Solution for the Challenges of Pediatric Drug Development Blog Stepwise PIPs: A Solution for the Challenges of Pediatric Drug Development Early paediatric investigation plan (PIP) submissions – an unnecessarily bitter medicine? In the European Union…CertaraApril 14, 2023
Why Performing Key CMC Activities Early Can Aid De-risking Your Drug Development Program White Paper Why Performing Key CMC Activities Early Can Aid De-risking Your Drug Development Program This white paper focuses on best practices for developing a CMC strategy for orally administered…CertaraApril 13, 2023