The Baim Institute has proven expertise in study design across all development phases and types of trials. The trial design team collaborates with our sponsors both for protocol design and regulatory strategy discussions. This team has a long history of working with FDA and attending pre-submission and panel meetings with sponsors.
The Baim Institute’s engages a cross-functional team of subject matter experts, both from inside and outside the institute; the trial design team includes affiliated faculty clinicians and statisticians who provide the leadership necessary to design a study that will meet its scientific and regulatory objectives. This includes studies spanning all phases of clinical development to post-marketing studies.
Our trial design team can provide sponsors with the following: