Clinical Biometrics

Clinical biometrics is about more than just numbers. It’s about using rigorous statistics to shape a powerful and efficient study design as well as to uncover the critical insights hiding within the data. Precision’s Clinical Biometrics team delivers all this and more, maximizing your study’s accuracy, compliance and success.

Clinical Biometrics

Clinical biometrics is about more than just numbers. It’s about using rigorous statistics to shape a powerful and efficient study design as well as to uncover the critical insights hiding within the data. Precision’s Clinical Biometrics team delivers all this and more, maximizing your study’s accuracy, compliance and success.

Clinical biometrics that are a step above

Creative study design based on a deep understanding of standards, statistics, and clear communication
100%
DATA SUBMISSION ACCEPTANCE BY REGULATORY AGENCIES
15+
STUDIES RESCUED ON BEHALF OF CLIENTS
0
PRECISION STUDIES NEEDING RESCUE
Everything you expect a biometrics team to deliver
  • Full suite of biostatistics services, including
    • Study design
    • Randomization
    • Statistical analysis plan
    • Programming and data analysis
  • Full data monitoring committee (DMC) support including charter, member selection, administration and management, and tables, figures, and listings preparation
  • CDISC conversion capabilities and expertise
  • Reviewer’s guides preparation
  • ISS/ISE preparation
And everything else you need from a biometrics team to succeed
  • Statistical consulting
  • 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
    • 13 ISS (7 FDA; 6 EMA, PDMA, AUS, Canada)
    • 2 ISE (FDA and EMA)
    • 10 approvals (3 FDA, 4 EMA, PDMA, AUS, Canada)
    • 2 device 510(k) clearance

Case Study: Securing FDA approval for a new diagnostic when compared to the “gold standard”

Throughout this Phase 1 immunotherapy trial, the team collected samples to evaluate tumor biomarker expression and activity, as well as the degree and type of immune infiltration by immunohistochemistry. However, until the final cohort was reached without demonstration of adverse events, these were not analyzed in conjunction with the clinical data.

In diagnostic trials, it is common and often expected to compare performance of a new diagnostic to the “gold standard” based on current standard of care. After planning a study to assess typical measures of sensitivity and specificity, our sponsor was asked by the FDA to modify the primary endpoint used to interpret whether the new diagnostic was sufficiently comparable to the existing gold standard. The sponsor turned to Precision for Medicine to navigate the request.

Tell us about your project requirements

The deep experience and successful track record of our Biometrics Team are just a few 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 Biometrics Team are just a few 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