Scientific Affairs

A Menu of Services to Support Your Early Phase Clinical Research Study

We offer a full range of scientific affairs services, all combining the same high level of scientific expertise and attentive relationship-building that clients expect of Cetero. Whether you require comprehensive scientific affairs services or just one or two, we are ready to provide whatever is needed to support your early phase drug development program. Our services include:

Our strong scientific background and industry experience can enhance early phase study designs across virtually all therapeutic areas.

We provide expert consultation for pre-CTA/pre-IND, end of phase I, and pre-NDA meetings.

We consult on appropriate study designs and endpoints, provide all types of PK/PD analysis including global population PK/PD analyses and reporting, and develop modeling and simulations.

We develop analysis plans to present statistics most effectively, generate randomization schemes, create and validate SAS programs, generate tables, listings and graphs, and prepare statistical reports.

Cetero has a proven track record of delivering accurate data when you want it, in a format that is fully compliant, safe, reliable and easy to use. You can also rest assured that our electronic data capture is fully 21 CFR Part 11 compliant.

We provide protocol and informed consent development and review, ICH-compliant study reports (including SAS generated tables and listings) and clinical study reports for FDA, Health Canada and EMEA.

Whatever your scientific affairs needs, we’ll be happy to put together a package that gets you where you want to go.