Proof of Concept Studies

Proof-of-concept clinical studies are a means for rapidly determining the success of a project clinically before significant spending in the later stages of development.

This lean innovation model enables early testing and agile refinement of new products so that progression to manufacturing, scale up and larger clinical studies can be carried out with confidence,

There are several stages during clinical development where a proof-of-concept study could provide the crucial data prior to further investment. These can include:

  1. Scientific feasibility, gathering evidence and understanding of how your product works in vivo; this could be assessing regional absorption parameters or testing different variables such as drug dosing, rate of release or performance in fed vs fasted states.
  2. Early PK data can help a client to optimise their formulation at an early stage. It often goes hand in hand with a bioequivalence (BE) study, comparing the client product against a reference product.
  3. Post-marketing data, gamma scintigraphic studies can provide visual and reliable data showcasing the competitive advantage of their product in the market and using this for commercial and marketing purposes.

BDD can provide the following services during Proof-of-Concept (PoC) studies:

  • PK sampling
  • Gamma scintigraphic imaging of product performance
  • Multiple armed study – testing more than one protype in parallel
  • Adaptive clinical study for agile refinement of product performance and streamlining clinical development.

All of these components can be combined to provide a proof-of-concept study that is right for you.