Proof of Concept
Our comprehensive, integrated proof of concept study services help you achieve your critical milestones faster. Our experts in the design and conduct of phase I clinical trials will deliver your POC clinical research efficiently, effectively, and on time. With the research support of regulatory experts, bioanalytical scientists, experienced biostatisticians and medical writing teams, you can trust Altasciences with your proof of concept study. 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 Phase I clinical trial program. Altasciences has designed and conducted a wide range of FIH and stand-alone proof of concept clinical trials.
Consult our NDA-Enabling Fact Sheet
Proof of Concept Study Conduct Expertise
Our clinical pharmacologists perform background research, and consult with POC research 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 trial teams capture the endpoints in a consistent manner, training our staff to administer both objective and subjective proof of concept study tests in the exact same way. We also carefully educate participants in what is expected of them during a Phase I clinical trial.
We routinely perform POC clinical research in healthy participants, and leverage our access to a wide range of patient populations for indications that do not have models appropriate in healthy participants. Prior to starting a proof of concept 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 conduct POC research with smaller groups.
- 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 comprehensive support research services and bioanalytical expertise.