Unlocking Value and Insights from Your Data
Comprehensive statistical services and expertise for all phases of clinical development
Deep expertise in data science and the ability to extract value
They are a smart, proactive, and data-centered contract research organization (CRO) that provides high-quality, technology-driven biostatistical and data programming services.Dave Davidson, CEO Johnson and Dow
We are a smart, proactive, and data-centered contract research organization (CRO) that provides high-quality, technology-driven biostatistical and data programming services.
About Us
Since 2008, we have focused on precision analytics and complex modeling for our pharmaceutical and biotechnology clients during all stages of clinical development, including regulatory approval and post-market research.
Our aim is to communicate the value of your medical therapies through innovative and specialized insight into your data. We pride ourselves on our timely deliverables, high standards of accuracy, and comprehensive analytics expertise.
As your partner, our goal is to guide the analytical processes that ultimately advance your medical therapies to market success. We accomplish this through our commitment to excellence, accuracy, and conducting high-quality statistical analyses while maintaining the utmost degree of scientific integrity.
Our world-class and client-centric experts each hold an advanced degree in analytics, with at least 15 years of experience, and are dedicated to providing you with impactful and timely solutions for your clinical data needs.
Deriving Insights from Data
Founded in 2008, we are a clinical data science company dedicated to providing precision analytics and complex modeling for pharmaceutical and biotechnology clients. Our expertise is communicating the value of drug candidates by deriving innovative and specialized insights from clinical data. While our team works across a wide range of therapeutic areas, we specialize in those which can be particularly complex such as oncology, neurology and rare diseases.
The Princeton Advantage
Across All Stages of Development
Clinical Trials
Review / Approval Process
Our services span all stages of clinical development, including regulatory approval and post-market research. Our goal is to guide the analytical processes that ultimately advance your medical therapies to market success. We accomplish this through our commitment to excellence, the highest standards of accuracy, and conducting high-quality statistical analyses while maintaining the utmost degree of scientific integrity.
Our services include:
- Clinical Trial Statistical Planning
- Data Integration
- Data Review
- Statistical Analysis and Report
- Regulatory Data eSubmission
Our data scientists work closely with your development and commercial team to provide the clinical study data and analytic services across the entire drug development cycle.
Development Decision Point
(Phase II stage, start of the formal development):
Questions we answer include:
- Does the phase II study provide enough data for a clear decision to move to the full development stage of the Phase III program to meet FDA and commercial requirements?
- Does the clinical trial implementation operation produce high-quality data?
- Can we improve data collection based on the information acquired during the study?
When start working with a client at the beginning of the development decision point (Phase II), we help to de-risk the clinical development program in several ways:
- Study design to explore all possible endpoint candidates as phase III primary endpoint to find a clear path for moving to phase III
- Statistical centralized monitoring of key efficacy and safety data to improve data quality and early detection of data trends.
- Precision data analytics to uncover value to support the phase III program decision
Full Development Decision Point
(Phase III stage):
Questions we answer include:
- Does the study design have a sufficient margin of safety for the substantial and totality of the clinical evidence for drug approval?
- Does the data process meet the regulatory data submission standard and comply with data quality requirements?
- Can we use state-of-art analysis methods to answer the key clinical questions instead of designing an additional clinical trial?
When start working with a client at the beginning of Phase III of clinical development, we help to quickly expand the regulatory submission quality data analytics of the clinical development program in several ways:
- Statistical design to precisely quantify the treatment effect size to provide a margin of safety for the success of the pivotal study
- Highly validated data analyses to meet FDA regulatory submission standards and quality requirements
- Advanced data analytics to provide substantial evidence of value to ensure approval
Submission Decision Point
(Regulatory Review):
Questions we answer include:
- How do we quickly integrate past clinical studies to create the integrated efficacy and safety analysis database and analyses with 100% match with individual study results?
- How do we quickly create 100% CDSIC compliant standardized eCTD data package to submit to FDA?
- How do we quickly create the additional analyses on short notice from the regulatory agency?
When start working with a client at the beginning of regulatory filing, we help achieve a successful and speedy market approval by:
- Creating the 100% CDISC compliant eCTD data package for regulatory submission
- Integrating the summary of safety and efficacy with 100% consistency with individual study results
- Rapid analysis to respond to regulatory agency review inquiry
First Regulatory Approval
(post-approval Commercialization):
Questions we answer include:
- What are the additional analyses of the clinical trials to be conducted to support the drug launch?
- How can we show the clinical utility from the real-world data?
- What is the real-world performance of the drug based on the electronic medical records data?
When start working with a client at the beginning of post-approval commercialization, we help deliver effective scientific communication to doctors and value propositions to payers via:
- Post-hoc analysis for pivotal clinical studies for medical affairs communication
- Real-world patient journal from insurance claim data
- Real-world treatment effect study using electronic medical records data and disease registry data
Across All Stages of Development
Our services span all stages of clinical development, including regulatory approval and post-market research. Our goal is to guide the analytical processes that ultimately advance your medical therapies to market success. We accomplish this through our commitment to excellence, the highest standards of accuracy, and conducting high-quality statistical analyses while maintaining the utmost degree of scientific integrity.
With Unparalleled Expertise
Our team includes nine doctoral and two masters level statisticians. Each has at least fifteen years of experience and in-depth knowledge of CDISC compliance for regulatory submission.