Agile, Experienced
Clinical Trial
Management
Working as an extension of your team, Precision leverages decades of clinical trial management experience to accelerate your path to market. We recognize that each clinical development program faces its own unique challenges and have the flexibility and experience to tailor solutions for your program’s specific needs. Our services cover all aspects of clinical trial management and advance programs from emerging and midsize biopharma companies in North America, Western Europe, Eastern Europe, and Asia Pacific.
Study Start-up & Feasibility
Site selection informed by performance and real-world data, and in-depth analysis and understanding of the competitive landscape enable predictable enrollment.
Patient Recruitment
Advanced patient identification using informatics, deep connections with research centers, patient advocacy groups, and key opinion leaders help speed recruitment and start-up.
Project Management
Study-wide PMs collaborate across clinical operations and translational science, working closely with each site to deliver real-time, biomarker and clinical endpoint data for critical decision-making.
Personalized Trial Operations
Precision clinical research associates (CRAs) are assigned to a trial based on their experience and focus exclusively on 1-2 trials at a time, becoming experts in each one.
Biometrics
Precision’s team of clinical biostatisticians provides trial design consultation, statistical methodology recommendations, programming expertise, and data interpretation, delivering trial results efficiently and on time.
Medical & Safety Monitoring
Precision’s in-house team of licensed and board-certified physicians—all experienced in clinical research—know our processes, your disease state and how to keep your trial on track.
A unique approach to clinical trial management
Customized biomarker solutions integrated with global trial execution
New drug applications with biomarkers are three times more likely to be approved than applications without biomarkers. Precision researchers and scientists collaborate with sponsors to determine the correct biomarker strategy for a specific trial, then seamlessly integrate biomarker identification with trial design strategy, patient enrollment and segmentation, sample protection, and clinical trial execution. No other CRO offers Precision’s breadth of clinical trial operations and specialty lab services—and we offer it all under one roof.
Biomarkers are the beginning, not the end
It takes expertise to translate strong science into the insights that accelerate approval. Gerald Messerschmidt, Chief Medical Officer, Oncology, explains.
Case Study: Use of flow cytometry data to achieve optimal dose: A phase 1 immunotherapy trial
We are currently managing a two-part, phase 1 study that is examining the safety and efficacy of a novel agent: a recombinant, humanized monoclonal antibody targeting a specific receptor, resulting in potent antibody-dependent cellular cytotoxicity. Part 1 of the study is a dose escalation design, where we study escalating doses of the novel agent in combination with varying levels of different immunotherapies to help augment the level of antitumor activity of the immune response to the tumor cells.
In typical dose escalation studies, patients are treated with escalating doses of the study drug (in various combinations) until a certain level of unacceptable toxicities (adverse events) that are consistently seen in the treated patients is reached. The goal of these studies is to find the highest tolerated and safe dose, with a balanced amount of adverse risk.
Discover how our clinical trial management experts can advance your international clinical trial
Discover how our clinical trial management experts can advance your international clinical trial
Related clinical trial services
Clinical Trial Management
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.
Biomarker Strategies
We integrate clinical trial execution excellence with the power of biomarker assays and data science to provide robust insights for advanced asset value.
