Date: Tuesday, June 10th, 2014
Presented at: Bay Area CDISC Implementation Network
We frequently give this presentation to new clients, to let them know what to expect when planning a submission. Topics of this conversation include:
- Strategy and planning
- Specifying project deliverables
- Production and QC of analysis datasets and TFLs
- Evaluation of project deliverables
- Assembling and auditing the data submission
- Fielding FDA requests
- 120 Day Safety Update
- Preparing for the Advisory Committee meeting