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Achieve Late Phase Success with Precision

Navigate your late phase journey with efficiency and comprehensive solutions

Navigate complex Phase 2b-3 trials with scale and end-to-end solutions that propel your therapy towards market readiness. Precision for Medicine stands at the forefront of late phase clinical trials, offering scalability, full-service execution, and regulatory readiness to ensure your project's success.

 

Streamlining Success in Late Phase Trials

Strategic planning, patient recruitment, and operational efficiency are pillars of successful late-phase clinical trials. At Precision, we understand these challenges and offer a suite of services designed to optimize your trial’s performance from patient strategies to global operational execution.
  • Global CRO
  • Patient Strategies
  • Regulatory Approval
  • Precision Execution with Global Reach

    Leverage Precision's full-service outsourcing (FSO) or functional service provider (FSP) solutions to execute your late-phase trials with unmatched efficiency. Our global reach and integrated lab capabilities provide a one-stop solution, delivering consistency and quality across all study sites.

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    Global Teams-Reach
  • Enhancing Trial Efficiency with Patient-Centric Approaches

    Discover how Precision emphasizes patient engagement and the capability to conduct decentralized clinical trials (DCTs), reducing patient burden and improving enrollment. Our strategies are tailored to meet the unique needs of late-phase trials, ensuring high participation rates and diverse participant representation.

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  • Navigating the Path to Market

    With strategic regulatory planning and in-depth expertise with FDA and EMA submissions, Precision navigates the complex regulatory landscape, ensuring your study is positioned for approval. Engage our regulatory strategists to streamline your path to market.

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Oncology expertise by indication

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Rare disease expertise by therapeutic area

Rare Disease Expertise_May 24

Broadening Horizons in Late Phase Trials

As you approach the pivotal late stages of clinical development, Precision for Medicine stands ready with a comprehensive suite of augmentative services. These services are meticulously designed to not only support trial execution but also ensure seamless transition to commercialization, amplifying the impact of your therapeutic innovations.
  • Lab Services
  • Precision Technologies
  • IVD & CDX Regulatory
  • Precision Integrated Labs

    In the realm of late-phase development, the nuanced role of biomarkers becomes increasingly pivotal. Precision’s specialty and central lab services adeptly handle biomarker analysis, patient stratification, and safety monitoring, delivering the high-quality, actionable data essential for late-phase trials. Dive deeper into how our lab solutions can propel your therapy’s late-stage success.

    Explore Precision’s Labs
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  • Harnessing Technology for Insightful Breakthroughs

    Embrace the cutting-edge with Precision Technologies, where tools like Apostream, EpiontisID, and QuartzBio’s Biomarker Data Management redefine the scope of trial insights. With Virtual Sample Management and MetaVate, our technologies offer unparalleled depth to your data analysis, propelling your therapy’s journey with evidence-backed precision.

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    Risk Based Monitoring RBM
  • Regulatory Mastery for IVD & CDx

    With a century’s worth of combined expertise, Precision for Medicine’s IVD Regulatory Team offers unparalleled guidance for IVDs and Companion Diagnostics. Across continents and regulatory landscapes, we craft strategies that streamline global assay testing and registrations, ensuring your diagnostics meet global standards and accelerate your therapy's market entry.

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Precision late phase resources

Discover our collection of resources designed to optimize and accelerate your late phase development.

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  • Expanding your therapy's impact with Precision

    Beyond clinical trials, Precision for Medicine extends your reach into health economics, market access, and medical communications to ensure your therapy achieves its fullest potential and commercial success.

     

  • HEOR Strategy and Evidence

    HEOR Strategy & Evidence

    Shaping Value with HEOR

    Deploy Precision's HEOR expertise early to articulate your therapy's value, preparing for successful market access. We integrate economic and clinical insights to craft compelling narratives for payers and regulators.

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    Market Access Planning

    Navigating Market Access Landscapes

    Our strategic market access plans position your therapy for optimal reimbursement and adoption. Precision's insights into payer landscapes guide your product through to commercial viability.

  • HCP and Engagement

    HCP & Engagement

    Medical Communications for Adoption

    Utilize our medical communications expertise to foster therapy awareness and adoption. Precision balances clinical benefits with humanistic elements, enhancing therapeutic choice and market penetration.

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

    Award-winning CRO with deep oncology and rare disease expertise

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    Global Laboratory
    Services

    Exceptional translational and biomarker sciences with global central lab services

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Navigating late phase with Precision insights

Stay informed with the latest late phase and clinical trial insights from our experts, who share knowledge, trends, and success stories from the forefront of clinical research.

Read: FDA's Vision for Multiregional Clinical Trials in Oncology FDA's Vision for Multiregional Clinical Trials in Oncology

Clinical Trials - Regulatory - Oncology

FDA's Vision for Multiregional Clinical Trials in Oncology

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    Harpreet Singh, MD

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Read: Contract Research Organization vs Clinical Research Organization (CRO vs CRO) Contract Research Organization vs Clinical Research Organization (CRO vs CRO)

Clinical Trials

Contract Research Organization vs Clinical Research Organization (CRO vs CRO)

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies.  Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., avatar=Image{width=400,height=400,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Rob%20Maiale.jpg',altText='Rob Maiale',fileId=184765575245}, linkedin=https://www.linkedin.com/in/rob-maiale/, hs_name=, hs_path=, lastname=Maiale, hs_initial_published_at=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
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    Rob Maiale

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Read: The Amendment Trap: Why 76% of Clinical Trials Face Six-Figure Protocol Changes The Amendment Trap: Why 76% of Clinical Trials Face Six-Figure Protocol Changes

Clinical Trials

The Amendment Trap: Why 76% of Clinical Trials Face Six-Figure Protocol Changes

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=187570680222, hs_child_table_id=0, hs_updated_at=1742413198455, hs_published_at=1744844126301, description=Christine has been ensuring high performance delivery of clinical research projects for more than 23 years. During this time, she has successfully led diverse teams across various cancer indications including renal, pancreatic, melanoma, lung, head and neck, breast, multiple myeloma, extra-nodal NK/T lymphoma, non-Hodgkin’s lymphoma, and Hodgkin’s lymphoma. Within the CRO setting she also supported the strategic development of over 50 hematology/oncology programs including complex Phase 1 projects in immuno-oncology and autologous cell therapy. She also led the establishment of a novel oncology research infrastructure which accelerated study activations for Phase 1 solid tumor studies. Christine obtained her master’s degree in public health at the University of Texas where she also trained in the development and implementation of clinical and epidemiologic research at the Coordinating Center for Clinical Trials as well as the Center for Occupational and Environment Health., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Christine%20Lusk-1.png',altText='Christine Lusk-1',fileId=187579105870}, lastname=Lusk, hs_initial_published_at=1742410730688, hs_created_by_user_id=26433386, hs_created_at=1742410650472, hs_is_edited=false, hs_deleted_at=0, name=Christine, job=Director, Project Management, slug=christine-lusk, hs_updated_by_user_id=51739740}, second={}, third={}})
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    Christine Lusk

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Pioneer new therapies with Precision expertise

With Precision, your pioneering treatments in Oncology, Rare Diseases, and beyond are propelled from concept to reality, supported by teams with deep domain expertise and innovative approaches.