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We are regulatory statistics 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 evaluation 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

08 April 2019
Kammerman Consulting attends the 2019 DIA/FDA Biostatistics Industry and Regulator Forum


Attendee

North Bethesda, MD, USA
1 February 2019
DIA names Dr. Kammerman an Associate Editor of Therapeutic Innovation & Regulatory Science (TIRS) Journal


Associate Editor

Therapeutic Innovation & Regulatory Science (TIRS) Journal
17 October 2018
Longitudinal Modeling Approaches to Assess the Association Between Changes in 2 Clinical Outcome Assessments


Discussant

Webinar