Our Services and Methodology
Our statisticians develop statistical analysis plans, which reflect study goals and closely follow the ICH guidelines for the design of case report forms (CRFs), database structure, data plausibility checks, and quality control procedures as well as choice of study objectives, sample size calculation, inclusion/exclusion criteria, study endpoints, randomization, sample size and power, safety monitoring, and interim and final analysis of data. We produce final datasets directly from the electronic data capture database; this includes all relevant metadata and the accompanying final dataset documentation.
In addition, we offer state-of-the-science, objective health economics and outcomes research (HEOR). Our economists, clinicians, and biostatisticians perform analyses that clients use to assess the costs and benefits of potential and existing clinical and public health interventions. We assess the interventions’ impact on narrow populations with a very specific diagnosis, on broad populations, and on community health, and we communicate the return on investment to providers, payers, and society as a whole.
Work with us. Contact us to learn how we can find the right solutions for all of your clinical research needs.