Fully-Integrated Statistical Services

RCRI provides fully-integrated statistical services for clinical studies.  Our goal is to help clients decide the best statistical strategy for their clinical studies. RCRI biostatisticians have graduate degrees in statistics/biostatistics and real-world experience including positions in industry, academia, and government. We specialize in both frequentist and Bayesian design and analysis.

RCRI can help you:

  • Provide statistical support for pre-clinical studies
  • Determine the optimal statistical strategy for clinical trials
  • Utilize Bayesian adaptive approach to potentially accelerate your trials and decrease cost
  • Develop and justify sample size
  • Develop analysis plans, including comprehensive mock tables/figures/listings
  • Negotiate with the FDA and other regulatory agencies regarding the proposed statistical design and analysis methods
  • Prepare documentation and coordinate the safety committee (e.g. Data Safety Monitoring Board)
  • Serve as a liaison to or member of the DSMB when not involved in another part of the trial
  • Improve efficiency through automated reporting for annual/interim/final clinical reports
  • Write integrated reports, manuscripts and abstracts
  • Defend trial results to regulatory agencies

RCRI biostatisticians will work closely with your medical, regulatory, marketing and other departments to ensure statistical project deliverables are of the highest quality and are supplied on time.

RCRI Bayesian Expertise in Clinical Research

In order to maximize the impact and efficiency of clinical research today, study designs need to make the best use of historical and current study data. FDA supports the use of Bayesian and other adaptive statistical methods to integrate available information, optimize study sample sizes, and potentially shorten the time to market release.

RCRI has biostatisticians that assist clients with study design and analysis using Bayesian as well as frequentist methodologies. With the increased financial pressures faced by study sponsors today, the appropriate use of Bayesian and other adaptive methods may decrease study size and time to market.

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Regulatory and Clinical Research Institute

5353 Wayzata Boulevard, Suite 505, Minneapolis, MN 55416-1334 USA | info@rcri-inc.com | 952.746.8080

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