Early Phase
Trial (I-IIa) Services
A fully integrated CRO, Precision accelerates early-phase trials with services that cover all aspects of your study. We build clinical development strategies optimized for efficiency, develop advanced trial designs, provide specialty lab services, and generate insight with our proprietary QuartzBio® technology solutions for sample data and biomarker data management.
By working with Precision at the beginning of your clinical development program, or even earlier at the preclinical stage, you gain the full benefits of our biomarker-driven expertise.
Clinical development strategies for biomarker-driven trials
At Precision, we build clinical development strategies that not only answer early phase questions, such as maximum tolerated dose, but also anticipate the needs of later phase trials to ensure an efficient transition into late phase success. For some studies, this means collecting biomarker data that is more fully leveraged in a future trial.
For other studies, it means ensuring that the trial proactively addresses issues that could turn into regulatory bottlenecks at a later stage of development. Whatever your specific program requires, Precision will support your early phase trial with a clinical development strategy that incorporates your goals for later development.
Advanced trial designs for early phase trials
Precision’s experienced Biostatistics team supports your early phase trials with adaptive designs, such as basket, umbrella, and master protocol trials, that use biomarker data to increase the efficiency of your trial.
- Safety
- Endpoints
- Dose finding
- Randomization
- Patient selection
- Histology-independent treatment response
- Imaging
Learn more about Precision’s Clinical Trial Design
services >
Case Study: Use of flow cytometry data to achieve optimal dose: A phase I immunotherapy trial
Throughout the 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.
Upon completion of the final planned dosing cohort, the question remained, “did we achieve the final ‘optimal’ dose for more robust evaluation of efficacy, or were further refinements to dosing needed?” Without clinical evidence, it was necessary to rely on biomarker and immunohistochemistry data for insights.
Biomarkers in early phase trials: assays and data science
A comprehensive array of assays
With Precision’s comprehensive Specialty Lab Services supporting your early phase trial, you can leverage biomarker data as an early indicator of efficacy as well as to inform the dose-finding and dose-expansion decision process.
These assays include :
Unique data science capabilities
Modern, biomarker-driven programs generate massive volumes of data in the lab and the clinic. At Precision, we understand how valuable this data should be, and how the “right” data can lead you to insights that transform your program and profoundly impact patient health. Precision’s QuartzBio is the only platform to successfully integrate biomarker data; enable real time analysis visualization, and collaboration; and build a body of biomarker-driven evidence to support submissions.
QuartzBio: Precision’s engine for rapid insight generation
The QuartzBio enterprise Biomarker Data Management solution centralizes all biological data, including early-phase clinical data, exploratory data, preclinical data, and public repositories, across your enterprise—whether a single clinical program or a portfolio of hundreds of studies.
Proactive planning to optimize the use of biomarkers in oncology clinical trials
Discover how our early phase trial services can advance your drug or diagnostic development program
Discover how our early phase trial services can advance your drug or diagnostic development program
Explore our services
Clinical Trial Design
Advanced trial-design approaches-including basket, umbrella, and adaptive trial-deliver biomarker driven clinical research. Deep experience in these highly complex trial designs maximizes both insights and efficiency.
QuartzBio
Our QuartzBio team utilizes a proprietary technology platform to harmonize and integrate multiomic biomarker data as well as clinical data. We can then combine public datasets, and apply AI and computational biology approaches to maximize data insight.
Bioanalytical Testing
Bioanalytical analysis of biologics, cell therapies, gene therapies, and companion diagnostics development from the globally-recognized leaders in immunogenicity testing.
