Biostatistics Study Design Process

At AmPharm Statistics, we are a trusted firm that provides biostatistics study design services. If you have been tasked to undertake a research project and require statistical support, we’ve got your back. We provide biostatistics support services that cater to all stages of a research project.  Let’s find out more about our study design solutions and how you can benefit from them.

What is Study Design?

These days, dealing with data pertaining to living organisms, clinical trials, etc., is becoming increasingly complex and therefore requires rigorous planning, careful consideration, and extensive trial simulations prior to study start-up. With that, study design is the process of identifying and choosing the best design to increase the trial’s probability of success, deliver the appropriate drugs to the right patients, reduce the cost and overall time of the trial, and more. When it comes to study design, you may be required to plan and communicate your design to regulatory agencies, and then communicate and execute your study via your project team and investigational sites. This is where AmPharm Statistics can help you.

Why You Need Study Design

When it comes to facilitating the design and analysis of in-vitro studies and in-vitro guides, you will want to ensure that the most timely and accurate information is gathered to inform study design and conduct maximizing the data that can be accrued from the fewest number of study subjects while ensuring safe study conduct.  You will make your job less difficult by working with accomplished researchers and practicians that possess expertise in quality control, safety and efficacy, drug interactions, pharmacodynamics, dose-ranging, etc.

What AmPharm Statistics Offers for Study Design

Here’s a quick look at what we can provide to our clients when it comes to study design:

  • Review of data collection forms
  • Implement and/or develop randomization procedures
  • Develop monitoring plans pertaining to stopping rules for toxicity, interim efficacy analysis, and more
  • Participate in the process of identifying proper experimental designs
  • Review research protocols to ensure that they contain feasible aims and hypotheses, from a biostatistical point of view
  • Determine sample sizes via power analysis
  • Develop statistical analysis plans
  • Advise on database designs
  • Drafting sections of Statistical Analysis Plans (SAPs), IRB submissions, or grant proposals, and similar documents

Why Choose AmPharm Statistics for Study Design?

Founded in 1994, AmPharm Statistics has over 20 years of experience in the areas of biostatistics study design. Our study design solutions are flexible, timely, and accurate, and you can be sure that the solutions we offer will provide immense value to your needs. What’s more, our team of dedicated analysts also keeps up to date with the latest regulatory guidelines.

With specialized knowledge in the pharmaceutical, medical devices, and biotechnology areas, we pride ourselves as a client-centric firm that provides sound study design services. Whether you are looking to get study design support for the start or finish of your clinical trial, AmPharm Statistics can help.

If you would like to know more about our expertise in biostatistics study design, do not hesitate to email us at or call us at 844-674-3377 today.