Clinical trial design is one of the most important steps on the path to assessing or establishing the viability of a novel drug, device, biologic, diagnostic, or intervention.

At the Forefront of Trial Innovation

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:

  • 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

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