Our Solutions

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 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 proof of concept clinical trial teams ensure that we 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 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 proof of concept study, our recruiting department produces an accurate estimate of recruitment numbers and timelines. For some proof of concept study 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.

 

 

PARTICIPANTS

  • Healthy Participants
  • Patient Populations
  • 35 POC studies performed since 2014, including 14 both FIH and POC

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Proof of Concept - FAQs

What is clinical proof of concept (POC)?

Proof of concept clinical studies are an early stage of clinical drug development, when a compound has shown potential for human therapeutic use, after preclinical animal models and early safety testing. This step often links Phase I (first in human) and dose-ranging Phase-II studies. POC is a milestone in drug development, as it is a critical step towards marketing a viable human therapeutic  Read the relevant FDA guideline here.

What are some of the challenges associated with proof of concept study?

It is important to design your proof of concept study in such a way that you maximize your opportunities. Working with our regulatory experts, we provide guidance in consideration of preclinical results for design of POC clinical research, biomarker selection, possible additional evaluations required in the case of CNS activity, such as driving simulation or human abuse potential, and all the other details that should be considered for an efficient and effective proof of concept study.

Does Altasciences offer clinical trial monitoring?

Yes, we have a dedicated team of monitors who ensure your trial stays on track, from site selection and qualification through source document verification, eCRF review, and all other questions related to the successful conduct of your proof of concept study. [there is content for this on the website but it doesn’t seem to have an anchor? https://www.altasciences.com/bioanalysis-cro#bioanalysis-116910831

What services do you offer to help us beyond POC?

We offer CDMO manufacturing for small molecules for all phases of clinical trials (including blinding capabilities), through to commercial manufacturing and packaging. Our bioanalytical labs support trials to Phase IV and offer stand-alone services. In fact, all our research support services can be offered as stand-alone services, to support you up to, including, and beyond your POC clinical research.

THERAPEUTIC AREAS

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.

Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.

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Working as a flexible, attentive extension of your team, we offer all you need to move your molecule forward.