Services

Alpha Kappa Statistics LLC provides you with the biostatistical guidance you need to help you from the beginning of the clinical development lifecycle through to approval and marketing.

Offerings:
  • Preparation of clinical development plans
  • Design clinical trials with an eye on optimal design to expose the fewest subjects necessary to gain regulatory approval
  • Develop and review protocols using the most appropriate statistical methodology
  • Develop and review statistical analysis plans
  • Estimate sample size based upon expected clinical outcome
  • Prepare and review clinical study reports for regulatory submission
  • Support the Medical Affairs mission: prepare and review manuscripts, abstracts, and posters
  • Prepare for and participate in meetings with regulatory authorities (experience in most therapeutic areas and with most divisions at the FDA)
  • Serve on Data Monitoring Committees:  DMC Statistician/Independent Statistician and Adjudication Committees for clinical trials
  • Write statistically accurate press releases
  • Preparing for due diligence investigations (experienced in licensing and selling)
  • Identifying and recruiting talent
  • Consult on organizational issues

My Clients Come First

I am available to you 24/7 to ensure that you rest assured that you are getting the statistical support you need, with quality and timeliness.

I have had the privilege to work with Jeff at 2 companies. His comprehensive grasp of biostatistics is second to none. His leadership and managerial abilities are outstanding. And he always conducts himself as a gentleman. I have always enjoyed interacting with Jeff, and I have learned quite a bit about biostatistics because of my interactions with him. If I needed a biostatistics expert, Jeff would be my pick."

Jeffrey Freid, MD
Vice President of Pharmacovigilance & Risk Management
​Endo Pharmaceuticals
December 12, 2018

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