Biostatistics Consulting

With biostatistics consulting from Precision, your project will receive the same focus on quality, efficiency and collaboration that we deliver as part of a full clinical development program. You will gain confidence knowing that years of data science, clinical trial, and therapeutic biostatistics expertise are hard at work for you.

Biostatistics Consulting

With biostatistics consulting from Precision, your project will receive the same focus on quality, efficiency and collaboration that we deliver as part of a full clinical development program. You will gain confidence knowing that years of data science, clinical trial, and therapeutic biostatistics expertise are hard at work for you.

Biostatistics consulting with Precision

From advanced clinical trial design to ISS/ISE submission

Rigorous and collaborative biostatistics to ensure accurate insight

Full suite of biostatistics consulting services, including

  • Study design
  • Randomization
  • Statistical analysis plan
  • Programming and data analysis
  • Review and re-analysis of completed studies

Full data monitoring committee (DMC) support including charter, member selection, administration and management, and tables, figures, and listings preparation

  • CDISC conversion capabilities and expertise
  • ISS/ISE preparation
Quality-driven biostatistics expertise to help you succeed
  • Ad hoc requests
  • Deep understanding and adherence to regulatory standards, including participation in international SDTM and ADaM teams
  • Interim data analysis
  • An experienced team dedicated to quality, efficiency, and collaboration

 

Proprietary QuartzBio platform to maximize understanding

Bringing together all of your clinical, lab, and biomarker data, QuartzBio enables powerful translational informatics and computational biology approaches that maximize what you learn from every patient.

  • Biomarker-based patient stratification and selection
  • Biomarker signature development
  • Predictive modeling of drug response
  • Preclinical modeling
    • Target pathway selection
    • Identification of new indications for existing assets based on MOA and disease biology
    • Mapping of preclinical model biology to human disease biology
  • Characterizing mechanism of action
  • Co-therapeutic target pathway selection
  • Integration of prior biological knowledge

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.

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.

Explore other areas of expertise