Proof of Concept Studies: Phase IB-IIA

Demonstrate efficacy and dosage with enough power to convince new investors

As your project proceeds into Phase Ib-IIa trials, our translational science group provides the necessary foundation for success, moving the data derived from healthy humans into those in a disease state to confirm that the biochemical processes are the same.

The big focus here is determining dosage requirements. We administer the drug to a group of patients in various quantities to investigate dosage and the optimal frequency of doses — working to generate data powerful enough to show investors that the drug successfully treats the disease state and is ready to move into the next stage of development.

We have several groups and techniques to support this goal.

Proof of concept

Our adaptive pharmacology and proof of concept studies give you support for new clinical development no matter the therapeutic area. This range of knowledge makes us flexible enough to complement your capabilities with biostatistical know-how and eClinical technologies for any development focus. We also have interactive voice and web response systems ready to assist with everything from randomization and drug inventory to electronic data capture.

Super sites network

To help find the right volunteers for your development, we’re proud to offer super sites capabilities to connect you with the strength of a global investigator network. With our hospital-based clinical pharmacology research units and our databases, we can also help connect you with more volunteers more quickly, potentially cutting the number of investigator sites to decrease time and cost.

Bridging studies to demonstrate global efficacy

Global drug markets require global drugs whose safety and efficacy have been demonstrated for a wide range of populations. By intentionally recruiting subjects across a range of ethnicities during Phase II, you can minimize the need for later studies to confirm efficacy in other populations.

We are the only company in the industry that builds ethnobridging studies into clinical trials this effectively, from the beginning. This saves time, money, and propels your asset forward through global development.

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