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We are statistical regulatory experts

If you are ready to:

  • Anticipate questions from regulators
  • Obtain independent statistical regulatory reviews of meeting documents and study-related documents
  • Define study endpoints (including patient-reported outcomes) and analyses that are acceptable to regulators
  • Seek guidance on trial design and analyses
  • Obtain an independent statistical regulatory evaluations and interpretation of clinical study results
  • Stay focused on key topics at your regulatory meetings and advisory committee meetings
  • Glean regulatory insights from a highly qualified ex-FDA Master Reviewer

Then we are here to guide you.  Upfront preparation leads to the best possible regulatory submissions, fewer review cycles and, ultimately, getting safe and effective drugs to patients as early as possible.  And that’s what we aim to do.

Why Choose Us

Our founder worked 24 years at FDA/CDER and additional years in industry. Her knowledge and skills bring a unique and valuable perspective to your regulatory and statistical challenges. Consequently, we understand the expectations of regulators and industry and can help guide you to success.

Latest Events

17 October 2018
Longitudinal Modeling Approaches to Assess the Association Between Changes in 2 Clinical Outcome Assessments


Discussant

Webinar
2 October 2018
Advancing Endpoint Development for Preterm Neonates with Pulmonary Morbidities


Invited endpoints expert

Washington, DC
21 September 2018
Advancing the Science of Study Endpoints: Endpoint Evolution During Drug Development – Time to Deterioration Endpoint Case Study

Invited speaker and panel discussant

North Bethesda, MD