Making the complex simple
Are you having trouble designing your clinical trial? Let us help you answer questions like:
• How many subjects are needed to power your trial?
• Should the trial be designed to assess equivalence, superiority or non-inferiority?
• Should the treatment arms be cross-over or parallel groups?
• How many objectives are appropriate?
• How many endpoints are appropriate?
• How to randomize participants?
• Sample size calculation
• How to collect and manage the data?
• What if I can't blind the treatment allocation?
Design and analysis procedures are crucial to ensure integrity in any clinical trial.
Our team will work closely with you to carefully consider every aspect of the analysis
of your trial from input into the statistical section of your protocol, preparation of
the Statistical Analysis Plan (SAP) through to thorough blind review and final analysis.
We will work with you to address regulatory and reimbursement questions and
have experience interacting with the TGA, PBAC, FDA and EMA review process.
On completion, you will receive a statistical report to assist with interpretation which
can be directly incorporated into your Clinical Study Report (CSR).
We are detail orientated and treat your project individually to optimize the quality of