Biostatistics Protocol Development

At AmPharm Statistics, you can get unmatched solutions that meet your protocol development needs. Our firm specializes in clinical trial, biotechnology, and epidemiology of statistics.  Whether you work as a biotech drug developer or biologics researcher, we’ve got your back! Let’s find out how we can help you when it comes to protocol development.

What is Protocol Development?

Each clinical investigation typically starts with the development of a protocol. The protocol is a document that describes the objectives of the trial, its design, its methodology, and all statistical considerations. In addition, a well written protocol enhances the quality and integrity of the data collected and the safety of the trial subjects. At which stage is protocol development normally needed?  All stages!

Why You Need Protocol Development

The statistical aspects of a protocol are often integrally intertwined with other elements of a clinical trial. That’s why it is imperative for you to assure that the statistical foundation of your clinical trial is solid.  Protocol fine tuning will accelerate accrual of results and reduce costs.  This is where AmPharm Statistics comes in. We are able to help you develop protocols for your trials, spanning all phases of drug development in a wide range of disease areas. Our solutions can also provide guidance about method and timing of data collection, randomization procedures, sample size calculations, study outcomes, and more.

What AmPharm Statistics Offers for Protocol Development

Our team provides a range of strategic statistical advisement for protocol development, including:

  • Interim analysis
  • Randomization plans
  • Endpoint specifications
  • Sample size determination
  • Statistical analysis plans
  • Stopping rules
  • Accrual monitoring
  • DSMC and PRMC administrative support
  • Facilitate communication with regulatory authorities
  • Protocol development education and consultation
  • Developing safety and data monitoring plans
  • Perform quality assurance audits
  • Management and reporting of clinical trial data
  • … and more!

Why Choose AmPharm Statistics for Protocol Development?

At AmPharm Statistics, our company was founded more than 20 years ago. Since our inception, we have been providing reliable biostatistical protocol development solutions. We have a diverse clientele that comprises of private corporations, research institutions, government agencies, hospitals, and more. We understand that no two protocol development cases are the same, and that’s why we ensure our services conform to your specifications.

When you work with us, you can have peace of mind knowing that we continually strive to build long-term relationships with our customers, to ensure complete client satisfaction. Whether you are a mid-size or large-size company that specializes in pharmaceuticals, drug development, etc., we can help! Simply put, you can depend on us for insightful and accurate advice in a timely manner.

If you want to start tapping onto the expertise of our highly skilled biostatisticians for your protocol development needs, do not hesitate to schedule an initial consultation today. You can call us at 844-674-3377 or email us at