Skip to content
Precision for Medicine
AdobeStock_302075059

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.
Tumor_data

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.  

Read: Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions

Clinical Trials - Early Phase Research - Autoimmune

Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions

|
    has third author: false, (SizeLimitingPyMap: {main={hs_id=214928090133, hs_child_table_id=0, hs_updated_at=1781285625399, hs_published_at=1781630742683, description=Deborah Spencer is a Senior Director of Project Management at Precision for Medicine with over 25 years of experience in clinical research. She specialises in leading global clinical trials across multiple phases, with deep expertise in complex study delivery. Deborah provides strategic oversight of programmes, leads high-performing teams, and partners closely with sponsors to ensure successful execution and regulatory readiness., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Deborah%20Spencer.jpg',altText='Deborah Spencer',fileId=214838919278}, lastname=Spencer, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285562019, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job=Senior Director, Project Management, slug=deborah-spencer, hs_updated_by_user_id=26433386}, second={hs_id=214928170660, hs_child_table_id=0, hs_updated_at=1781285676367, hs_published_at=1781630742683, description=Anthea Gates is a Project Director with approximately 30 years of drug development and medical device industry expertise across all phases, over a variety of indications including breast, lung cancer, solid tumors and lymphoma, cutaneous T-cell lymphoma, malignant melanoma, squamous cell carcinoma, rare haematologic disease, autoimmune rheumatology, osteoarthritis, ocular burns, liver cirrhosis, myopia and pre-eclampsia. Committed to delivering quality and passionate about building positive relationships with clients and study teams to promote cohesive business practices and ensure the successful management of projects from start to finish. Anthea holds a proven track record in effective leadership of cross-functional teams across programs of studies, to the accomplishment of operational excellence., avatar=Image{width=372,height=546,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/profile.jpg',altText='profile',fileId=214846873938}, lastname=Gates, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285639221, hs_is_edited=false, hs_deleted_at=0, name=Anthea, job=Project Director, slug=anthea-gates, hs_updated_by_user_id=26433386}, third={hs_id=214928090141, hs_child_table_id=0, hs_updated_at=1781285738567, hs_published_at=1781630742683, description=Claire Delaville is a Senior Project Manager at Precision for Medicine. She brings 18 years of experience across preclinical and clinical research, including more than a decade leading Phase I to IV studies in oncology, rare diseases, and immunology, with direct experience in first-in-human and multicenter oncology trials. Claire is responsible for maintaining study quality through inspection readiness, corrective action planning, and proactive risk mitigation. She also oversees study budgets and vendor performance to support coordinated delivery across functions, drawing on a scientific foundation that includes a PhD in Neurosciences and Neuropharmacology. Based in Paris, France, Claire aligns scientific insight with operational execution to support successful trial outcomes., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Claire%20Delaville.jpg',altText='Claire Delaville',fileId=214838927033}, lastname=Delaville, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285678112, hs_is_edited=false, hs_deleted_at=0, name=Claire, job=Senior Project Manager, slug=claire-delaville, hs_updated_by_user_id=26433386}})
  • Deborah S. avatar Anthea G. avatar Claire D. avatar
  • Deborah S.

    Anthea G.

    Claire D.

Discover
Read: Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies

Clinical Trials

Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=213698206365, hs_child_table_id=0, hs_updated_at=1780680681226, hs_published_at=1781630742683, 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=26433386}, second={}, third={}})
  • Rui F Duarte-Lopes avatar

    Rui F Duarte-Lopes

Discover
Read: Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx

Assays - Oncology

Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1781630742683, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, PhD, hs_initial_published_at=1775839468505, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, position=Vice President, IVD Regulatory Consulting, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=26433386}, second={hs_id=164426546714, hs_child_table_id=0, hs_updated_at=1778171432595, hs_published_at=1781630742683, description=Angélique Heckmann, PhD is a people‑driven leader who combines scientific expertise and business acumen with a strong foundation in human values. With a background in therapeutic drug development and an MBA‑shaped strategic mindset, she focuses on building meaningful, long‑term relationships with teams, partners, and clients. By bridging science and strategy, she supports informed decision‑making, fosters collaboration, and helps translate innovation into real‑world impact—always guided by a shared purpose: advancing solutions that ultimately improve patients’ lives, avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/angelique-1.png',altText='angelique-1',fileId=194126030110}, lastname=Heckmann, PhD, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713172107894, hs_is_edited=false, hs_deleted_at=0, name=Angelique, job=Regional Vice President, Translational Business Solutions, slug=angelique-heckmann, hs_updated_by_user_id=26433386}, third={}})
  • Kennon D. avatar

    Kennon D.

  • Angelique H. avatar

    Angelique H.

Discover

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

    →LEARN MORE

    Clincal-dvp
  • 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.

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.

  • Discover Explore
    clinical-trial-support

    Global CRO
    Services

    Award-winning CRO with deep oncology and rare disease expertise

    Explore
  • Discover Explore
    specialty-lab-services

    Global Laboratory
    Services

    Exceptional translational and biomarker sciences with global central lab services

    Explore