We have extensive experiences in applying statistical methodologies in medical product development. We design advanced pre-clinical and clinical studies and conduct sophisticated statistical analysis to evaluate your medical product and prepare for your regulator approval submission.
We design innovative and complex pre-clinical and clinical studies. By applying flexible Bayesian or frequentist methodologies, we will work with your team to develop pre-clinical experiment plan and clinical protocols that will save your cost and time.
Our experts in medical therapeutic and diagnostic devices will design clinical trials to meet the special FDA 510(k) or PMA submission requirements.
The amount of real-world data collected from sources other than protocol-driven clinical studies is increasing ultra-rapidly. The clinical evidence that can be derived from analysis of these real-world data can complement the knowledge derived from traditional well-controlled clinical trials. We have developed novel methods that have been accepted by the FDA for leveraging real world evidence in clinical trial design and anlysis.
