Clinical
Trial Project
Management
The speed and success of Precision’s studies are built on a foundation of excellence and expertise in biomarker-driven clinical trial project management. In addition to the focus on quality you would expect from any CRO, our teams have the experience in combining translational science and clinical operations that ensures maximum insight from every patient sample.
Clinical trial project management with Precision
Strong, reliable, flexible, and effective
We keep you informed
The Precision approach to clinical trial project management gives you all the access and information you need about your study with none of the overwhelm.
- Dedicated project manager for oversight, coordination, and single point-of-communication
- Access to the entire expert team, as needed
- Customized study dashboard with project status, patient tracking, and key performance metrics
- Weekly project oversight with operational managers
- Monthly operational oversight with operational executives
- Bi-annual business oversight with senior executives
We execute with Precision
From start to finish, both on-site and off, our processes and personnel ensure quality, safety, and efficiency.
- In-depth study start-up procedure proactively manages risks and establishes comprehensive study-specific plans and documentation
- Highly consistent processes and rigorous study-specific training reduce error and deliver reliable study data
- Collaborative engagement with both you and key site personnel ensures accurate study execution
- Experienced CRAs work on only 1-2 projects, making them study-site experts for your study
Case Study: Use of flow cytometry data to achieve optimal dose: A phase 1 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.
“Our philosophy is to assign our monitors to just one or two trials at a time. This allows them to become true experts in the study and helps optimize data quality.”
Pat Devitt Risse, PharmD
President, Clinical Solutions
“Our philosophy is to assign our monitors to just one or two trials at a time. This allows them to become true experts in the study and helps optimize data quality.”
Pat Devitt Risse, PharmD
President, Clinical Solutions
Tell us about your project requirements
Biomarker-driven clinical trials require specialized expertise and experienced management that most CROs don’t have. At Precision, biomarker-driven trials are our passion—let us put our experience and expertise to work for you.
Tell us about your project requirements
Biomarker-driven clinical trials require specialized expertise and experienced management that most CROs don’t have. At Precision, biomarker-driven trials are our passion—let us put our experience and expertise to work for you.
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.
