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See Beyond the Keyhole with RBQM Clinical Trials

Increase data integrity with our expert scientific and analytics data review teams
The Clinical Science & Centralized Monitoring  experts at Precision redefines data integrity through a fusion of scientific expertise and cutting-edge analytics. Powered by our proprietary platform, Clinscope, we deliver a smarter, more agile approach to risk-based quality management—one that prioritizes what matters most: critical data, patient safety, and regulatory confidence.
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Precision’s RBQM Clinical Trials Framework is Built for What’s Next

Streamline your clinical journey, enhance efficiency and accelerate your path to success with expert data integration, analysis, and interpretation.

Using an integrated model that shifts away from traditional monitoring, we replace exhaustive reviews with targeted, insight-rich analysis.

  • 50+ pre-built dashboards tailored for rapid insight and therapeutic relevance
  • Clinscope-powered centralized monitoring detects outliers, trends, and site-level risks with precision
  • Therapeutic-specific standards (RECIST v1.1, iRECIST, IMWG, Lugano, etc.) ensure consistency and accuracy
  • Proprietary data visualization tools allow for highly focused strategic reviews, catching complex issues beyond programmed edits
  • Proactive tech-enabled alerts flag complex data quality issues before they escalate
  • Cross-functional collaboration across Medical, Biostats, Data Management, and Clinical Ops ensures holistic data integrity
  • Real-time analytics drive quality outcomes and support pivotal trial decisions

By leveraging therapeutic expertise and real-time data visualization, complex trial data transforms into actionable intelligence to accelerate timelines and empower smarter decisions across the study lifecycle.

20 Avg. years research experience
15 Avg. years oncology experience
20 Global team members
8 Avg. years with Precision

Lifecycle RBQM Support From Start-Up to Submission

Our Clinical Science & Centralized Monitoring team combines scientific rigor with scalable innovation. With decades of therapeutic experience and global reach, we apply risk-based quality management (RBQM) and centralized monitoring to ensure data fidelity from study start-up through database lock. Powered by Clinscope visualization tools and therapeutic-specific standards, every stage of your trial is guided by clarity, confidence, and control.

  • Start-Up

    Start-Up

    Aligning data capture with protocol and therapeutic standards

    Our experts ensure the study design is built on a solid foundation for data precision.

  • Conduct

    Conduct

    Centralized, holistic, therapeutic data review

    Dashboards and real-time analytics highlight site-level risks while expert reviewers identify issues standard checks miss.

  • Risk Mitigation

    Risk Mitigation

    Proactive alerts and cross-functional collaboration

    Tech-enabled signals flag issues before they escalate, supported by Medical, Biostats, Data Management, and Clinical Ops teams.

  • Lock

    Lock

    On-time, confident database lock

    Continuous centralized review streamlines final medical review and prepares submission-ready datasets.

Insights from Precision’s experts

Stay ahead with the latest insights from Precision’s team of experts. Discover valuable perspectives, updates, and strategies to navigate early and late phase development.  

Explore our blog
Read: Why Most Early Autoimmune Trials Fail to Yield Decision-ready Evidence Why Most Early Autoimmune Trials Fail to Yield Decision-ready Evidence

Early Phase Research - Autoimmune

Why Most Early Autoimmune Trials Fail to Yield Decision-ready Evidence

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=213698206365, hs_child_table_id=0, hs_updated_at=1780680681226, hs_published_at=1786473638412, description=Rui F. Duarte‑Lopes is a senior biostatistics leader with over 31 years of international experience across biopharmaceutical, biotechnology, and CRO sectors. He provides strategic statistical oversight, ensuring rigorous, high‑quality, and decision‑focused delivery aligned with sponsor and regulatory expectations. He has more than 12 years of CRO experience supporting Phase I–IV clinical trials and has held roles including Lead Statistician, Project Lead, and Senior Manager. His therapeutic experience includes oncology and autoimmune diseases, notably lupus erythematosus, Crohn's disease and rheumatoid arthritis. Specializing in oncology over the past six years, Rui focuses on advanced solid tumors and early‑phase studies, contributing to study design, interim analyses, and data‑driven decision frameworks., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Rui%20F%20Duarte-Lopes.jpg',altText='Rui F Duarte-Lopes',fileId=213695319705}, lastname=Duarte-Lopes, hs_initial_published_at=1779886328878, hs_created_by_user_id=26433386, hs_created_at=1779886165792, hs_is_edited=false, hs_deleted_at=0, name=Rui F, job=Senior Manager, Biostatistics, slug=rui-f-duarte-lopes, hs_updated_by_user_id=65712240}, second={}, third={}})
  • Rui F Duarte-Lopes avatar

    Rui F Duarte-Lopes
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Read: Why Global Oncology Evidence May Not Support U.S. Regulatory Approval Why Global Oncology Evidence May Not Support U.S. Regulatory Approval

Clinical Trials - Regulatory

Why Global Oncology Evidence May Not Support U.S. Regulatory Approval

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1786473638412, description=Industry-leading oncologist and demonstrated medical leader in precision medicine, novel trial design and innovative regulatory initiatives designed to expedite drug approvals. Draws on nearly a decade leading oncology and rare disease programs at the FDA. Former fellow at the National Cancer Institute and frequent featured speaker at ASCO and AACR. CDER technical authority on oncologic drug and biological products for thoracic and head and neck malignancies, neurologic tumors, pediatric solid tumors and rare tumors., avatar=Image{width=553,height=580,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Harpreet-Singh2.png',altText='Harpreet-Singh2',fileId=171747124346}, linkedin=https://www.linkedin.com/in/harpreetsinghmd/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Singh, MD, hs_initial_published_at=1715692570942, hs_created_by_user_id=2737751, hs_created_at=1715692477118, hs_is_edited=false, hs_deleted_at=0, name=Harpreet, job=Chief Medical Officer, slug=harpreet-singh, hs_updated_by_user_id=65712240}, second={}, third={}})
  • Harpreet Singh, MD avatar

    Harpreet Singh, MD
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Read: Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors

Clinical Trials

Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=164713188870, hs_child_table_id=0, hs_updated_at=1754641424769, hs_published_at=1786473638412, description=Deana Demjen is Director of the Precision Site Network, bringing nearly 20 years of clinical research to the role. Most of her previous experience has been in feasibility and site-identification. She has been covering a wide range of therapeutic areas, but her main focus are rare diseases where she is an acting subject matter expert. She is responsible for relationships with PSN sites as well as the maintenance and expansion of the network., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Deana-Demjen-1.png',altText='Deana-Demjen-1',fileId=194123711869}, lastname=Demjen, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713363112834, hs_is_edited=false, hs_deleted_at=0, name=Deana, job=Director of PSN, slug=deana-demjen, hs_updated_by_user_id=65712240}, second={}, third={}})
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    Deana Demjen
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Delivering Clinical Success Across Phases

  • Clinical Development Strategy

    Unlock the full potential of your clinical trials with our tailored Clinical Development Strategies. Designed to navigate the complexities of trial execution, Precision can propel your program toward accelerated success.

    Services Offered: 

    • Clinical Development Planning
    • Clinical Trial Design
    • Biomarker Trial Strategies
    • Basket, Master & Umbrella trials

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  • Full-Service CRO

    Experience seamless integration and meticulous management of your clinical trial with our Full-Service CRO. We ensure every detail is managed with expertise to drive your study towards its successful completion.

    Services include, but are not limited to: 

    • Full-service Study Management
    • Study Start-up & Feasibility
    • Clinical Monitoring
    • Medical Monitoring
    • Drug Safety & Pharmacovigilance
    • Data Management
    • Biostatistics

    →LEARN MORE

    CRO

  • Precision FSP

    Amplify your clinical trial efficiency with Precision’s Functional Service Provider (FSP) solutions, offering specialized support focused on your project's unique needs.

    Solutions Offered:

    • FSP Clinical Monitoring
    • FSP Drug Safety & Pharmacovigilance
    • FSP Data Management
    • FSP Biostatistics
    • FSP Statistical Programming
    • FSP Medical Writing

    →LEARN MORE

    FSP

Advance therapeutic breakthroughs with Precision

Explore the breadth of our expertise in therapeutics and modalities, as we lead your novel treatments in Oncology, Rare Diseases and beyond, from the groundbreaking idea to clinical realization.

Oncology Explore Rare diseases Explore Autoimmune Explore Gene Therapy Explore Cell Therapy Explore

Specialized capabilities in every stage of clinical development

Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to accelerate speed to market. Precision can customize and converge our capabilities to meet your program's unique needs—driving efficiency, agility, and success from start to finish.

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    Global CRO
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    Award-winning CRO with deep oncology and rare disease expertise

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    Global Laboratory
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    Exceptional translational and biomarker sciences with global central lab services

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