End of Phase 2 Meeting
The time will come when you need to review and obtain agreement from the FDA on your study designs for Phase 3 and an End of Phase 2 meeting is necessary. During this meeting you need to effectively present your Phase 3 and submission strategy and ensure that you are aligned with the FDA prior to the start of Phase 3.
Preparation for End of Phase 2 Meeting
To move you to the next clinical trial phase, The Weinberg Group will diligently work with you to prepare for the End of Phase 2 meeting. With your input, we will:
- Develop the End of Phase 2 briefing package to be sent to FDA in advance of the meeting.
- Request the End of Phase 2 meeting.
- Determine meeting objectives and agenda, and script the participants.
- Conduct a meeting rehearsal at our headquarters in Washington, DC.
- Attend the meeting with you, and summarize results in formal notes.
- Conduct a debriefing session to discuss accomplishment of meeting objectives and finalize meeting minutes to be sent to the FDA.
The Weinberg Group: Continuing to Phase 3
Our team of experts will work closely with you to ensure your End of Phase 2 meeting with the FDA delivers the feedback necessary so you may continue with your Phase 3 clinical trials.