The Baim Institute has proven expertise in study design and execution across all phases of clinical development 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.

Our trial design team can provide sponsors with the following:

• Evaluation of anticipated regulatory pathway
• Assistance in the drafting of white papers and concept sheets
• Drafting of protocol synopses and full protocols, including:

• • Sample size calculations
  • Statistical methods
  • Endpoint definitions
  • Study procedures
  • Schedules of assessments

• Staffing and management of study steering committees
• Medical writing
• Management of Publications Committees