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FDA Veteran Paz Vellanki, MD, joins Precision to become one of 3 ex-FDA oncology leaders supporting clients

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Clinical Trial Management Services

Clinical Trial Management Services

Global clinical trial management for life-changing therapies

From first patient in to last patient out, Precision for Medicine delivers seamless clinical trial management that accelerates timelines and ensures quality. Our global team, advanced infrastructure, and proprietary technologies guide every step, helping you overcome complexity and achieve your development goals.

Your Trusted Global CRO Partner for End-to-End Clinical Trial Management

3500
Clinical Research Professionals Deep expertise for every phase
40
Global Locations Reach and scalability where you need it
20
Years of Experience Trusted by leading innovators worldwide
600
Global Trials Proven success across key therapeutic areas

Award-Winning Clinical Trial Management Services

Precision for Medicine combines expert teams, global reach, and advanced technologies to simplify complexity and deliver results. By transforming data into actionable insights and applying agile processes, we empower every phase of your trial—from concept to completion—to achieve milestones faster and set new industry standards.
  • Clinical Trial Strategy & Planning
  • Accelerated Study Start Up
  • End-to-End Clinical Trial Execution
  • Seamless Regulatory Submission

How We Deliver Success

Integrating regulatory expertise, global development strategy, and operational excellence ensure seamless trial execution and expedited regulatory submissions. All of this is powered by a robust quality and technology platform that enables real-time risk mitigation and proactive quality management, giving you confidence at every stage.

 

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  • Regulatory Expertise

    Regulatory Expertise

    Integrating regulatory, clinical, and medical expertise to guide your program from IND through NDA. Our strategies are led by ex-FDA experts, ensuring compliance and accelerating approvals.

  • Strategic Planning

    Strategic Planning

    Global reach with local expertise. We coordinate global and regional hubs, manage country-specific regulatory planning, and optimize site selection for faster, smarter trial start-up.

  • Operational Excellence

    Operational Excellence

    Data-driven clinical execution supported by strong site partnerships. Standardized global processes, centralized monitoring, and real-time dashboards keep your trial on track and on time.

  • Governance, Quality & Insight

    Governance, Quality & Insight

    Multi-tiered governance structures backed by real-time analytics and risk-based monitoring. Continuous improvement ensures quality and mitigates risk throughout your trial.

Advancing Outcomes at Every Stage

With 42.5% of our work in early-phase development and 57.5% in late-phase studies, we deliver expertise across the entire clinical lifecycle. From innovative trial design and regulatory strategy to large-scale execution, we handle complexity and accelerate timelines, helping you achieve success from IND through NDA.
 
  • Discover Early Phase Excellence
    clinical trial patient doctor

    Early Phase Excellence

    Expert trial design and biomarker strategies to optimize early-phase studies. Navigate regulatory pathways and accelerate start-up for faster insights and smarter decisions.

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  • Discover Late Phase Success
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    Late Phase Success

    Proven global capabilities to manage large-scale trials with precision. Our integrated approach ensures compliance, quality, and efficiency, driving success from pivotal studies to submission.

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  • Next-Gen Technologies and Data Infrastructure That Accelerate Trial Insights

    Industry-leading platforms like Veeva and proprietary solutions such as Cliniscope and Metavate enable data-driven trial execution and improve efficiencies at every stage of development. Our advanced technology ecosystem transforms complexity into actionable insights, empowering smarter decisions and faster progress.

  • ISSISE data flow
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    Integrated Clinical Trial Management

    Partnership with Veeva for CTMS, EDC, and eTMF capabilities. Expertise with leading EDC platforms and next-generation clinical trial technology providers.

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  • Centralized Monitoring and Risk-based Quality Management
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    Clinscope

    Real-time safety and trial insights with CliniscopeTM. Centralized monitoring and RBQM model for proactive risk management.
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  • Automated Clinical Data transformation
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    Metavate

    Automated, metadata-driven clinical data transformation to expedite regulatory submissions. MetavateTM enhances biostatistics and statistical programming capabilities, helping sponsors accelerate timelines and reduce time to market.

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  • Decentralized Clinical Trials
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    Decentralized Clinical Trials

    30+ specialist vendors partnering with Precision around the world for DCT execution. Expertise in rare and pediatric study delivery ensures flexibility and patient-centric solutions.

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  • AI and analytics driven trial optimization
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    AI-driven Trial Optimization

    AI-forward strategy and smart automation across trial stages to enhance efficiencies and drive smart outcomes.
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Global Clinical Trial Management Case Studies

  • Read Case Study

    Case Study - ONCOLOGY

    Conducting Autologous Cell Therapy Research Across Continents

    This Phase 1–2 autologous cell therapy study spanned sites across the U.S. and Europe, each operating under distinct regulatory frameworks.
    Engaged to oversee trial execution, discover how Precision for Medicine coordinated complex cross-border logistics and site readiness, achieving zero sample or IP loss throughout the program.
    • 3
      continents
    • 0
      sample loss
    Read Case Study
  • Read Case Study

    Case Study - ONCOLOGY

    Phase 3 Prostate Cancer Case Study: Radiopharm Imaging at Scale

    This Phase 3 PSMA-targeted imaging trial in prostate cancer, ran across the U.S. and Canada, required on-time administration of a short-lived radiopharmaceutical within hours of delivery.  Read how this study scaled while maintaining dose-on-time compliance, zero site shutdowns, and robust imaging data quality.

    • 380+
      participants
    • 0
      Data quality issues
    Read Case Study
CRO Leadership Awards 2024

Award-winning clinical trial management services

Precision for Medicine’s recognition in the 2024 CRO Leadership Awards across every category reflects more than excellence—it underscores our commitment to advancing your clinical trials. Our award-winning expertise delivers not only superior trial management but also a shared mission to bring transformative therapies to patients worldwide.

See how consistent industry recognition demonstrates our dedication to quality, innovation, and success in clinical trial management.

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Deep experience with debilitating disease and unique modalities

 

We understand that every development pathway begins and ends with a patient. Supporting our partners in delivering innovative treatments is our purpose. Leverage our proven expertise across complex therapeutic areas and advanced modalities to bring transformative therapies to those who need them most.

Oncology Explore Rare Diseases Explore Autoimmune Explore Gene Therapy Explore Cell Therapy Explore

Frequently Asked Questions

How many countries can Precision for Medicine support simultaneously?

Precision delivers truly global trial management, supporting studies across North America, Europe, Asia-Pacific, and Latin America through an integrated network of local experts and regulatory specialists.

We routinely manage multi-country, multi-regional oncology and rare-disease trials, ensuring harmonized trial conduct, consistent data quality, and rapid study start-up across all participating regions.

What is the typical timeline for first-patient-in in multi-region trials?

Timelines vary by indication and geography, but Precision focuses on accelerating feasibility, regulatory submissions, and site activation to expedite FPI timelines.

Our global start-up model—supported by predictive feasibility, country-specific regulatory intelligence, and centralized project governance, typically enables FPI within 3–6 months in priority markets.

How do you manage global regulatory submissions and country-specific compliance?

Our regulatory operations team manages end-to-end global submissions, from IND/CTA strategy and dossier preparation to ongoing Health Authority engagement across each region.

We combine local regulatory expertise, global SOPs, and centralized quality oversight to ensure every country meets its specific requirements, reducing delays, preventing rework, and ensuring inspection-readiness throughout the trial.

How do you manage patient recruitment and retention across regions?

Precision uses data-driven enrollment forecasting, site-level analytics, and real-time centralized monitoring to identify risks early and optimize recruitment strategies.

Our teams work closely with investigators to implement country-specific outreach plans, streamline pre-screening, and support protocol adherence — all of which strengthen retention, diversity, and time-to-enrollment.

What is your monitoring model for global trials (remote vs on-site)?

Every trial is different and we tailor the monitoring strategy to align with the needs of each program. Precision also offers a hybrid monitoring model that is built on: 

  • Centralized monitoring for real-time insight into data quality and patient safety
  • Risk-based approaches informed by analytics to focus resources where they matter most
  • Flexible remote and on-site visits aligned with regulatory expectations
This approach provides faster detection of issues, lowers burden on sites, and maintains data integrity across regions.

Can you support decentralised or hybrid trials across multiple regions?

Yes. We design and manage decentralized and hybrid trial models across multiple regions, leveraging remote assessments, digital tools, home-health services, and flexible visit schedules.

Our operational framework ensures regional regulatory compliance, data integration, and consistent patient experience, making complex global DCTs feasible, scalable, and audit-ready. 

Read our latest Precision insights

Stay updated with the latest insights in statistical programming and automation through our blog. 

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Read: Case Study: Rapid Execution of Assay Validation Rescued Global Study Case Study: Rapid Execution of Assay Validation Rescued Global Study

Translational Research - Assays

Case Study: Rapid Execution of Assay Validation Rescued Global Study

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    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. avatar

    Christie B.
  • Kennon D. avatar

    Kennon D.
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Read: Clinical AI at Scale: Why Trust Matters More Than Speed Clinical AI at Scale: Why Trust Matters More Than Speed

Clinical Trials

Clinical AI at Scale: Why Trust Matters More Than Speed

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    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. avatar Shakila J. avatar Sugumaran M. avatar

  • Zulfat K.

    Shakila J.

    Sugumaran M.
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Read: Hidden Strategic Edge in Clinical Trials: Financial Project Management Hidden Strategic Edge in Clinical Trials: Financial Project Management

Clinical Trials

Hidden Strategic Edge in Clinical Trials: Financial Project Management

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=218300089344, hs_child_table_id=0, hs_updated_at=1785358312044, hs_published_at=1787135938204, description=Global Finance leader with 35+ years of progressive experience and over two decades in the global CRO industry. Proven track record of building and developing high-performing teams, leading complex financial operations, and driving strategic initiatives that improve business performance and scalability. Deep expertise in financial planning and analysis, contract negotiation, budgeting and forecasting, process optimization, auditing, cash flow management, and credit and collections. Passionate about fostering collaboration across finance, operations, and executive leadership to deliver data-driven insights, strengthen governance, and enable informed decision-making both internally and for our Sponsors., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/1576750031793.jpeg',altText='1576750031793',fileId=218305569797}, lastname=Kane, hs_initial_published_at=1785358316248, hs_created_by_user_id=65712240, hs_created_at=1785358281109, hs_is_edited=false, hs_deleted_at=0, name=Romy, job=Vice President, Operational Finance, slug=romy-kane, hs_updated_by_user_id=92535535}, second={}, third={}})
  • Romy Kane avatar

    Romy Kane
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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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    Global CRO Services

    A recognized leader in oncology and rare diseases with rich experience in complex trials

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    Laboratory
    Services

    Experts in translational and biomarker sciences with worldwide specialty labs and central lab services that are enabling breakthroughs.

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