First to File

Watch days disappear from your development timeline!

Being First to File can give generic companies 180 days of potential marketing exclusivity for their product: 180 days of no competition, 180 days to stock shelves with their product, 180 days to build a successful foundation for hefty long-term success. That’s a six month head start over competitors.

Cetero can take you from first dose to final study reports in as little as 25 days. That’s less than half the normal time – an unprecedented achievement in the industry.

Why doesn’t everyone do it? Because they can’t. As the leading early phase CRO, Cetero has resources and experience no one can match. We develop detailed, coordinated project and communication plans that involve multiple Cetero sites (St. Louis, Toronto and Fargo) and multiple functions: study protocol development, the clinical conduct of two studies (fasted and fed), dedicated lab facilities, sample bioanalysis, statistical analysis, and writing of both eCTD final reports. And we pull them all together with unusually nimble project management.

We have shortened the timeline with concurrent work processes. And we do it all while rigorously ensuring quality, protecting participant safety and minimizing risk. First to File requires planning so precise that the duration of many activities is scheduled down to the hour, rather than the typical duration unit of days.

Grab your best shot at First to File. Contact us today for details.