Biostatistics Study Design

Precision’s biostatistics study design team has years of proven success designing and implementing advanced clinical trials that leverage biomarker assays, including basket, umbrella, adaptive, and master protocol trials. Get highly informative and efficient studies when you partner with Precision.

Biostatistics Study Design

Precision’s biostatistics study design team has years of proven success designing and implementing advanced clinical trials that leverage biomarker assays, including basket, umbrella, adaptive, and master protocol trials. Get highly informative and efficient studies when you partner with Precision.

Biostatistics study designs with Precision

Our extensive trial design experience ensures efficient and informative trials

Years of study design and therapeutic expertise

With an average of >10 years’ experience in all biostatistical aspects of clinical trials, our approach to clinical trial design is based on in-depth knowledge of how to achieve success.

We have the therapeutic expertise to choose the best endpoints to meet your study objective (see the Case Study below for one example).

Study design for successful drug development

Our Biostatistics team considers each study as a critical and fully integrated part of your overall clinical development program. We work with you and the regulatory agencies to ensure that the data from your trial are summarized in a way that facilitates decisions and progress along your clinical development pathway. From sample size calculations, design considerations, to analysis planning and execution, we work closely with your full clinical development team to ensure you have the data you need to make timely decisions.

Case Study: Biostatistical analysis leads the FDA to change an orphan drug ruling

In rare inherited metabolic disorders, predefining the best endpoint to demonstrate efficacy of a new treatment can be challenging. We worked with one sponsor who was developing such a treatment. When results from the placebo-controlled clinical trial proved unimpressive, the contract research organization (CRO) that conducted the trial, satisfied it had followed the established statistical analysis plan, concluded there was nothing further to be done.

The sponsor then turned to Precision for Medicine Oncology and Rare Disease to see what could be salvaged from the data. We recognized immediately that the study’s established primary endpoint simply was not the best metric by which to judge success. Our task was to secure FDA approval for the drug based on the new proposed efficacy endpoint.

“We go beyond thinking about ‘what does this study need’ to ‘what do you as a company need to be successful’ so that we can get treatments quickly to the patients who need it.”

Elizabeth Ludington
Senior Vice President, Biometrics

“We go beyond thinking about ‘what does this study need’ to ‘what do you as a company need to be successful’ so that we can get treatments quickly to the patients who need it.”

Elizabeth Ludington
Senior Vice President, Biometrics

Tell us about your project requirements

The deep experience and successful track record of our biostatistics team are just two of the many reasons to choose Precision for Medicine. Contact us to learn more.

Tell us about your project requirements

The deep experience and successful track record of our biostatistics team are just two of the many reasons to choose Precision for Medicine. Contact us to learn more.

Clinical trial services

Global Clinical Trial Footprint

Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

Clinical Development Strategy

Tailored strategies consider the scientific, regulatory, and commercial factors that shape each trial, mitigating risk and advancing the development pathway.

Clinical Trial Design

Advanced trial-design approaches—including basket, umbrella, and adaptive trials—deliver biomarker driven clinical research. Deep experience in these highly complex trial designs maximizes both insights and efficiency.

Biostatistics

Seasoned biostatisticians and statistical programmers deliver insight into every trial phase, from study design to regulatory submissions, all backed by meticulous documentation and data monitoring.

Clinical Sample Management

Sample inventories from a global network of labs supply real-time processing in 55 countries; consolidated data from central labs, screening labs, and specialty labs with clinical data create actionable reports.

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