Regulatory

Approval for trials

We understand and have experience in the regulatory requirements for statistical proof and can assist you in the preparation and delivery of presentations to regulatory authorities (FDA and European) including

• Study design
• Choice of endpoints
• Sample size and power calculations
• Proposed statistical analysis
• Clinical feasibility and justification
• Final report

Dossier

• Analysis and writing for ISS / ISE
• Independent dossier review prior to submission to the regulatory bodies to ensure that the information is optimally presented.

Responding to questions

We have extensive experience in responding to questions from FDA and other regulators.

We are able to

• Perform additional analyses where required
• Design and implement meta-analyses
• Support appeals procedures