New Flexible Service Through Our Scientific Advice Program

Drug sponsors can now request a flexible service through our Scientific Advice program that can include a shorter time frame.

For Scientific Advice after pivotal trials designs are finalized, the program now offers more timely advice on anticipated key uncertainties or evidence gaps based on the clinical evidence plan. This flexible service can be completed with a lower fee in as little as 4 weeks.  

In addition, the Standard Scientific Advice process is still available before and after pivotal trial protocols are finalized. Sponsors may request a flexible service for the standard process, in as short as 8 weeks instead of the standard 14 weeks between the Briefing Book submission and Scientific Advice meeting dates. Standard fees ranges for this service will apply.    

Please contact us for more information at [email protected]. We are happy to work with you to customize the offering to best meet your needs.