BDD SWIFT is an adaptive clinical trial design that integrates formulation development, GMP manufacturing and clinical testing into one streamlined service: offering a more flexible approach than the conventional clinical trial design structure.
BDD Swift uses real time clinical data to inform formulation choices in successive arms within a single study. This platform enables rapid iterative clinical testing of formulation variants and speeds up successful product development.
Key stages in a successful BDD Swift clinical study:
Incorporate carefully considered variables within a pre-determined design space to allow optimisation of formulation performance in vivo.
Clinical Trial Design
An adaptable clinical trial design enabling rapid optimisation of your product with a minimal number of study arms.
Rapid evaluation of pharmacokinetics
Quick and accurate results from each study arm allows time to evaluate data and quickly initiate formulation changes before the next dosing.
Why Use BDD Swift?
Traditional pharmaceutical development pathways perform product development and clinical testing sequentially, even though current in vitro tools cannot predict in vivo performance. This can result in a ‘trial and error’ process with product performance not fully understood until the last stages of lengthy, expensive development and scale-up cycles.
BDD Swift provides an alternative to this classical model by enabling product performance to be optimised using continuous feedback from real clinical results to direct formulation design in real time.
Additional benefits include providing early indications of development project feasibility without the significant financial and time commitments traditionally associated with manufacturing larger scale clinical trial batches. This enables products to get into the market faster, bringing significant gains to our clients through early revenue generation.
At BDD we do not see ourselves as just a service provider, we work collaboratively with our clients, ensuring success through our combined expertise.
Advantages offered by BDD Swift Studies
By engaging with both our formulation scientists and clinical experts from the beginning we work with you to develop an adaptive clinical plan, which delivers:
- Science enabled decisions that ensure optimal results.
- Clinical data to intelligently inform formulation development.
- A more efficient route to market.
Our clinical team are co-located with and work closely alongside our formulations lab to share expertise and knowledge to ensure that what we deliver goes beyond your expectations.