ECG provides Accelerated Approval guidance by:
- Assisting you in devising a communication plan that addresses public health sensitivities as well as issues concerning unmet need and proposed treatment
- Facilitating message construction and issue resolution
- Helping you build your statistical argument
- Supporting your development of a strong rationale for a surrogate or substitute endpoint
- Working with your team to present a compelling plan for Phase 4 confirmatory trials
- Preparing your team to be clear, concise, and persuasive in telling the story of your product's development
Accustomed to working with companies on the Accelerated Approval path, ECG is well-positioned to guide your team successfully through the process.
Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information about our Accelerated Approval services.