Synthetic and External Controls

Enabling regulatory submissions of your single arm trial data by developing appropriate comparisons

Synthetic and External Controls

Customer problem

Increased use of single arm trials in oncology or rare diseases requires appropriate comparisons to be developed to document the benefits of the new treatment. Deriving such comparisons from real world or historical trial data is not straightforward and requires data source and methods expertise.

 

What we do

We select the most appropriate data source based on the requirements of the comparison to be performed. We then harness the latest advances in Bayesian dynamic borrowing, propensity score adjustment and epidemiological microsimulation modelling to derive synthetic controls capable of standing up to clinical and regulatory scrutiny.

 

Customer outcome

More streamline clinical development program. Time and cost savings. Rigorous scientific evidence presented to the regulators.