What role can a Statistician play in regulatory support? What kind of support is best?

Carrying on in our Statistical Consultancy Speed Dial series, this week we’re looking at when you need support for regulatory interactions.

At various points during the drug development journey, the sponsor will need to meet with regulators and answer questions about the trial. Whether reviewing a proposed trial design, attending an end of Phase 2 meeting or preparing for submission, no CMO would walk into any such make-or-break discussions without the support of a knowledgeable Statistician. 

The support of a flexible, highly skilled Statistician is fundamental during this process, and can support the sponsor either directly, playing a key role within the room, or behind the scenes, preparing regulatory responses and briefings. 

Having an established, ongoing relationship with a statistical consultant that has experience of regulatory interactions is invaluable. Statistical consultants have the background knowledge and understanding of the trial programme, build established relationships with the sponsor team, and provide the necessary flexibility and expertise to respond quickly should questions arise. 

An example from the team:

An example where Veramed provided regulatory support on a consultancy basis can be seen recently with a client who needed to discuss various aspects of their study design with the FDA. One of our statistical consultants produced simulations for a range of scenarios that were included in the briefing document provided to the regulatory agency. They were also able to attend the meeting alongside the sponsor to answer questions about the design and influence a successful outcome. 

Understanding when to use statistical consultancy for regulatory support starts with open and direct communication, which is where we come in. We’re able to provide a highly flexible statistical consultant who can give you the right support when you need it.

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