Blueprint for Success for Effective and Efficient Clinical Protocols

What You Will Learn

Clinical study protocols are vital to drug development, and when carefully designed, deliver practical clinical care and answer critical research questions. This balance of science and medicine provides the foundation for advancing the next big idea from the laboratory to the pharmacy. Still, this achievement is dependent on each drug’s ability to demonstrate safety and effectiveness during the phases of a clinical trial. Explore with us as we discuss different protocol writing and study design approaches, ensuring protocols are designed to meet both the patients’ and Sponsor’s needs, and maintaining compliance with the International Council for Harmonisation requirements.

Attendees will learn about:

• Key differences in clinical study design among phases of development
• Statistical methods for interpreting analyses
• New efficiencies in clinical study design strategy -Benefits of using the master or subprotocol
• Benefits of tech-enabled templates

Our Experts

• Aaron Burr, Senior Medical Writer, Regulatory and Medical Writing
• Tasnim Hoda, Manager, Regulatory and Medical Writing
• Hung Lam, Principal Biostatistician, Biometrics
• Victoria Murray, Technical Manager, Regulatory and Medical Writing