Statistical Analysis Plans (SAPs)

At AmPharm Statistics, we understand that clinical studies can be complex scientific experiments, and generating evidence to answer questions regarding the efficacy and safety can be challenging. That’s why we provide stellar biostatistical solutions.  These include development of  statistical analysis plans (SAPs).

What are Statistical Analysis Plans (SAPs)?

A SAP is recognized as the prospective blueprint of the planned statistical methods and analyses for a clinical study, and is written in accord with the clinical protocol.  It defines the statistical output for the clinical study report CSR), which includes listings, figures, and shell tables. However, you should keep in mind that the latter is not formally part of a SAP. Next, there are four different types of statistical analysis plans: Interim statistical analysis plans, data monitoring committee statistical analysis plans, integrated statistical analysis plans, and statistical analysis plans for clinical studies. All in all, SAPs are designed to bring a team together on the same page and add a critical layer of specificity to the project.

Why You Need Statistical Analysis Plans (SAPs)

If you are the sponsor of a clinical trial, SAPs ensure you get the output you need for your CSRs and related reports. For biostatisticians, you will be able to delineate all statistical methods and inferential analyses. Lastly, if you are a programmer, SAPs can provide you with explicit guidance on SAS and other programming and more. Below is a quick look at some more pertinent reasons why you need and will benefit from SAPs:

  • Maintain consistency between TFL shells and SAP text
  • Ensure consistency in study protocol; especially study objectives and endpoints
  • Gain ability to set data handling rules – algorithms for derived variables, imputation of missing data, and more
  • Allows definition of all analysis populations
  • Improve transferability of statistical methods into SAS® and other code
  • Ensure the appropriateness of statistical methods used for a clinical study

What AmPharm Statistics Offers for Statistical Analysis Plans (SAPs)

We provide SAP services that will bring together the following:

  • Primary and secondary objectives (includes any possible changes)
  • Sample blinding, randomization, and size
  • Safety parameter evaluation
  • Drug or treatment study compliance
  • Handling missing data and interim statistical analysis
  • Analysis of efficacy and safety endpoints
  • Baseline characteristics and demographics
  • Definitions of populations and disposition of study participants

Why Choose AmPharm Statistics for Statistical Analysis Plans (SAPs)?

AmPharm Statistics has been providing statistical analysis plans (SAPs) solutions for over two decades. Since our inception, we have been serving a diverse clientele that includes academic and research institutions, healthcare organizations, government agencies, and more. If your organization ever faces difficulty at any step in the process, you can always count on the SAP expertise of our team of highly skilled biostatisticians.

When you work with us for your SAP needs, you can have peace of mind knowing that we always maintain effective and frequent communication with our clients, and deliver accurate and insightful advice in a timely manner.

If you are interested in engaging our help for statistical analysis plans (SAPs) expertise, we encourage you to schedule an initial consultation. You can send us an email to rmacarthur@researchpharmacy.com or call us at 844-674-3377.