Statistical Consulting

ACI understands that the statistical interpretation of clinical data is essential in determining the best indication for the drug, device, or medical treatment, with a focus on safety and efficacy. Without proper statistical support, navigating regulatory and marketing challenges may prove challenging.

ACI offers you years of experience in all aspects of statistical support. Whether you need an objective, third-party opinion or a SWAT team approach, ACI can help. We seek to be your biometric partner. Our experience and expertise provide you with the necessary support you need to ensure high quality results.

For Larger Pharma and Biotech – Services offered:

• Blinded review of data (assumption testing)
• Interim analysis
• ISS & ISE development
• Mock agency review of NDA (or other filing) in preparation for filing
• Advisory Committee planning, preparation, and representation
• Pressure testing of analyses performed for pivotal trials for NDAs, sNDAs, etc.

For Smaller Pharma and Biotech – Services offered:

• Study Design
• Sample size and power estimation
• Randomization schedules
• Interim analyses
• Analysis plans
• ISS & ISE development
• Special Protocol Assessment (SPA) support for key clinical trials
• Expert Statistical Consulting for key clinical trials
• Life cycle support
  • Review of Clinical Development Plans
  • Representation at regulatory agencies for key meetings
    • End of Phase II
    • Pre-NDA
    • Advisory Committee
    • Review period leading to approval, labeling
  • Pre- Peri- and Post- Approval Support
    • Publication strategic planning and production
      • Posters
      • Abstracts
      • Manuscripts
  • Outcomes research
  • Health Economics

ACI offers you our years of experience designing trials, performing statistical analyses, and working in an FDA regulated environment. We have extensive experience supporting 510(k) and PMA medical device clinical trials.

For Medical Devices – Services offered:

• Clinical Trial Design and Sample Size Determination
• Detection of Failure and Defect Trends for CAPA*
• Statistical expertise in:
  • Analysis of Variance
  • Multiple Linear Regression
  • Multiple Logistic Regression
  • Proportional Hazards Regression
  • Categorical Data Analysis
  • Repeated Measures Data Analysis
• Evaluation of Diagnostic Tests
• Instrument Development
• Life Cycle Stress Fatigue Test Design and Analysis
• Longevity Forecasting
• Reliability and Failure Rate Prediction from field performance data
• Process Validation
• Tools & Training for Statistical Quality Control
• Exploratory analysis
  • Helping you to organize and analyze your growing "mountain of data"  in order to help you understand where the "gold" may be found
  • Provide information to the Medical Affairs and Marketing teams in order to make the best use of your data for publication strategy support

*Corrective and Preventive Action