During an E2E consultation, the evidence required by various stakeholders (e.g. regulators, payers, patients, healthcare providers, and physicians) to make informed decisions will be identified and incorporated into the design of a prospective study. We will work with the investigator to design a study that includes both efficacy and effectiveness endpoints, provide advice on suitable populations to include in the effectiveness phase of the trial, create a statistical analysis plan, and identify the role of the Data Safety Monitoring Board in moving from the efficacy to the effectiveness phase.
To select this service on the intake form, please choose “Other” and enter “E2E Consultations”.