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.

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.

Precision CSAI's Smart Patient Profiles clearly are the result of a lot of effort. They are certainly an extremely helpful tool to monitor patient data.

— Medical Director, Small Biotech
Precision's use of Smart Patient Profiles projects patient data to support informed decision-making. We have found them to be instrumental.

— Project Manager, Midsized Biotech
Precision is part of our team. They put in long days and hard work to help us create the slide deck that allowed our study to move forward. We are so appreciative of how fast they worked.

— Senior Manager, Clinical Trials, Midsized Biotech
Precision's use of Smart Patient Profiles projects patient data to support informed decision-making. We have found them to be instrumental.

— Project Manager, Midsized Biotech

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

Translational Research - Assays

Case Study: Rapid Execution of Assay Validation Rescued Global Study

Aug 20, ‘26 | 7 min read

has not third author: true, (SizeLimitingPyMap: {main={hs_id=219184495938, hs_child_table_id=0, hs_updated_at=1786473626295, hs_published_at=1787135938204, description=Christie Bongel is a scientist by training, but her true passion lies in leadership, particularly in building leaders and shaping high-performing, trust-based cultures. She believes that many talented bench scientists are promoted into management roles without formal leadership development and is committed to helping close that gap. While culture and people development may not always appear on a balance sheet, she views them as essential drivers of long-term organizational success. As a leadership-focused operations executive, Christie leads laboratory operations and strategy within a global network, partnering with pharmaceutical and biotechnology organizations to navigate complex oncology challenges. Her work spans translational oncology, clinical trial strategy, and laboratory execution, with a focus on translating scientific and operational complexity into clear, actionable strategies that drive meaningful outcomes., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/1781614819314.png',altText='Christie Bongel',fileId=219203862915}, lastname=Bongel, hs_initial_published_at=1786473638412, hs_created_by_user_id=65712240, hs_created_at=1786473568408, hs_is_edited=false, hs_deleted_at=0, name=Christie, job=Site Director, slug=christie-bongel, hs_updated_by_user_id=92535535}, second={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1787135938204, 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=92535535}, third={}})

Christie B.
Kennon D.

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Clinical Trials

Clinical AI at Scale: Why Trust Matters More Than Speed

Aug 18, ‘26 | 6 min read

has third author: false, (SizeLimitingPyMap: {main={hs_id=219402396746, hs_child_table_id=0, hs_updated_at=1787057935787, hs_published_at=1787135938204, description=Zulfat Kapadia is a Statistical Programmer with a scientist's heart and a programmer's precision, bringing over 11 years of experience in clinical data analytics. She currently works as a Statistical Programmer at Precision for Medicine, focusing on clinical data transformations and safety analytics. She is a SAS-certified Statistical Programmer with strong expertise in CDISC standards (SDTM and ADaM), turning raw clinical data into clean, submission-ready datasets and TLFs (Tables, Listings, and Figures). Her journey began with an M.Sc. in Microbiology from Gujarat University, followed by years as a Research Associate, where she worked hands-on with method development, validation, and LC-MS/MS analysis in GLP-regulated labs, including navigating regulatory audits. She later moved into SAS programming at Cognizant, building the technical foundation for her current specialization. A resourceful team player, she continues expanding her expertise across clinical and pharmaceutical domain., avatar=Image{width=1024,height=1536,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Zulfat%20Headshot.jpg',altText='Zulfat Headshot',fileId=219402357006}, lastname=Kapadia, hs_initial_published_at=1786648737451, hs_created_by_user_id=65712240, hs_created_at=1786648684030, hs_is_edited=false, hs_deleted_at=0, name=Zulfat, job=Statistical Programmer, slug=zulfat-kapadia, hs_updated_by_user_id=92535535}, second={hs_id=219402396744, hs_child_table_id=0, hs_updated_at=1786648683717, hs_published_at=1787135938204, description=As Principal Statistical Programmer, Shakila plays a key role in leading statistical programming activities for clinical development programs at Precision for Medicine. She has extensive experience managing study deliverables, supporting regulatory submissions, implementing CDISC standards, and collaborating with cross-functional teams to ensure high-quality and compliant clinical data outputs. Prior to joining Precision for Medicine, she held programming roles at ICON and Quintiles, where she contributed to global clinical trials across Oncology, Cardiovascular, Vaccine, and Diabetes therapeutic areas. She has led the development and validation of SDTM, ADaM, TLFs, define.xml, and submission-ready datasets for major health authorities including the FDA, PMDA, and EMEA. Beyond her expertise in SAS programming and clinical data standards, Shakila is passionate about process improvement, automation, and mentoring teams. She has recently expanded her capabilities in Data Science, gaining practical experience in Python, Machine Learning, R, and Tableau, and is keen on leveraging modern analytics and AI-driven approaches to enhance clinical research solutions., avatar=Image{width=1024,height=1536,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Shakila%20J%20Headshot.png',altText='Shakila J Headshot',fileId=219402114740}, lastname=Jagadeesan , hs_initial_published_at=1786648737451, hs_created_by_user_id=65712240, hs_created_at=1786648634345, hs_is_edited=false, hs_deleted_at=0, name=Shakila, job=Principal Statistical Programmer , slug=Shakila-Jagadeesan, hs_updated_by_user_id=92535535}, third={hs_id=219402097154, hs_child_table_id=0, hs_updated_at=1786648633237, hs_published_at=1787135938204, description=As Senior Manager of Statistical Programming, Sugumaran brings a wealth of experience to his role at Precision for Medicine, since March 2021. Prior to Precision for Medicine, he was associated with ICON Clinical Research for over 10 years across various roles in statistical programming. He has been actively involved in leading large and complex submissions for a diverse client base including large biopharma, biotech, and CROs. In addition to building his expertise in statistical programming, data analytics, and data visualization, he is deeply passionate about developing talent and cutting-edge software solutions. He is also actively involved with several social causes and CSR activities. Sugumaran holds an MBA in Pharmaceutical Management and a Master's in Bioinformatics. He is also currently pursuing a PhD in Bioinformatics., avatar=Image{width=1024,height=1536,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Sugumaran%20headshot.png',altText='Sugumaran headshot',fileId=219402130472}, lastname=Muthuraj, hs_initial_published_at=1786648737451, hs_created_by_user_id=65712240, hs_created_at=1786647962706, hs_is_edited=false, hs_deleted_at=0, name=Sugumaran, job=Senior Manager, Statistical Programming , slug=Sugumaran-Muthuraj, hs_updated_by_user_id=92535535}})

Zulfat K.

Shakila J.

Sugumaran M.

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Clinical Trials

Hidden Strategic Edge in Clinical Trials: Financial Project Management

Aug 17, ‘26 | 5 min read

Romy Kane

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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
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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
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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.

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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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Award-winning CRO with deep oncology and rare disease expertise

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Exceptional translational and biomarker sciences with global central lab services

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