Pharmaceutical Industry Statistics

At AmPharm Statistics, we specialize in providing pharmaceutical statistics solutions. With our wide ranging experience with biostatistics, we are able to support you in your preparation for regulatory hearings, responding to deficiency letters, evaluating and designing studies, and more. Whether you require biostatiscal support for Phase 1 clinical trials or analysis of datasets for later phase studies, we've got your back.


Biostatistics Support Service

Biostatistics support services are designed to provide you with expert early consultation on all aspects of basic data management, biostatistics, and study design for effective translational and clinical studies. With these support services, you will be able to address more clinical questions and conduct clinical research with greater ease. Here's a quick look at the biostatistics support services that we provide:

Innovative Clinical Trial Design

We have entered the era of precision healthcare. That is why researchers are exploring new ways to improve the drug development process, by matching novel treatments to specific patients (those most likely to respond), in order to deliver benefits and shorten drug approval times. Innovative clinical trial design is an excellent way to facilitate efficient trials, as opposed to traditional trial designs which can be resource intensive and take a long time to implement.

Innovations in clinical trial design may involve the addition of sequential randomizations or multiple intervention arms, allowing for more questions to be answered in a single trial and making better use of limited resources. At AmPharm Statistics, we offer stellar innovative clinical trial design solutions designed to cover:

  • Efficacy and Safety Endpoints
  • Bioequivalence Analysis
  • Non-Inferiority Designs
  • Adaptive Designs
  • Phase 1 Clinical Trials
  • Phase 2 Clinical Trials
  • Phase 3 Clinical Trials
  • Interim Analysis Planning
  • Sample Size Reassessment
  • Interim Analysis for Futility
  • Interim Analysis for Efficacy
  • Simple and Complex Randomization Schedules
  • Sample Size Calculations
  • Novel End Point Development
  • Interactive Voice Response System (IVRS) Dataset Analysis and Requisite Actions

Simulation and Modeling

Also known as model-informed drug discovery and development simulation and modeling of drug development processes are designed to deliver significant clinical, scientific, and business value. Simulation and modeling has the ability to optimize crucial drug development decisions, lower the cost of R&D investments, and more. Here's what AmPharm Statistics can provide when it comes to simulation and modeling:

  • Trial Enrollment Projections
  • Endpoint Projections
  • Sensitivity Analysis of Efficacy or Safety Data
  • Analysis Dataset Development and Data Cleaning
  • Study Design Testing and Comparison
  • Simulated Data Sets

Why Choose AmPharm Statistics for Pharmaceutical Statistics?

AmPharm Statistics has a wealth of experience working with both small and large pharmaceutical companies, research organizations, and more. Our extensive experience in statistics allows us to provide services that are both timely and cost-effective. You can rest assured that our team of highly trained personnel stays up-to-date with the latest regulatory guidelines. We have been in the business for more than 20 years and we possess unmatched knowledge in statistics.

If you wish to find out more about AmPharm Statistics and our pharmaceutical statistics solutions, do not hesitate to call us at 844-674-3377 or email us at to schedule an initial consultation.