Proof of Concept
Proof-of-concept (POC) studies present unique challenges in both design and conduct. Working with a CRO skilled in both is vital for the success of your study.
Altasciences has designed and conducted a wide range of FIH and stand-alone POC studies.
Our clinical pharmacologists perform background research, and consult with specialists, to ensure we craft the ideal design to meet your objectives, including collaborating with our preclinical colleagues to select the models or biomarkers that translate from preclinical to clinical. Our clinical teams ensure that we capture the endpoints in a consistent manner, training our staff to administer both objective and subjective tests in the exact same way. We also carefully educate participants in what is expected of them.
We routinely perform POC in healthy participants, but also use our access to a wide range of patient populations for indications that do not have models appropriate in healthy participants. Prior to starting a study, our recruiting department produces an accurate estimate of recruitment numbers and timelines. For some indications, we can recruit a large number of patients (i.e., more than 50 patients in areas like diabetes, obesity, and osteoarthritis), while in others, we are restricted to smaller groups.
Consult our NDA-Enabling Fact Sheet
- Healthy Participants
- Patient Populations
- 35 POC studies performed since 2014, including 14 both FIH and POC
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.