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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

Oncology Indication Experience_May24

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
  • Manufacturing Solutions
  • 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.

    Explore Precision 360 Intelligence
    Risk Based Monitoring RBM
  • Navigating to Commercial Readiness

    As your therapy edges closer to commercialization, the complexities of manufacturing demand a strategic approach. Precision’s Manufacturing Solutions, specializing in advanced therapies, ensure your journey from clinical scale to market readiness is both scalable and compliant, setting the stage for your therapeutic innovation’s successful launch.

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    Drug-Cell Manufacturing
  • 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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    IVD CDx development

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 increase speed to market. Incorporate manufacturing expertise for advances therapies to ensure scalability. Precision can customize and converge our capabilities for your program's unique needs.

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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: 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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    Christine Lusk

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Read: Best Practices to Streamline Development of Safety Update Reports (DSURs) Best Practices to Streamline Development of Safety Update Reports (DSURs)

Clinical Trials

Best Practices to Streamline Development of Safety Update Reports (DSURs)

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=182849803084, hs_child_table_id=0, hs_updated_at=1731697230236, hs_published_at=1742413203456, description=Lena Randhawa, PhD is a Principal Medical Writer at Precision for Medicine. She brings to Precision >23 years of written and oral communication experience and >12 years of regulatory medical writing experience, project management, and leadership roles. Lena has extensive experience across various regulatory documents including CSRs (interim CSRs, CSR amendments/addenda, and abbreviated/synoptic CSRs), CSR patient narratives, DSURs/IND annual reports, IBs and updates, clinical protocols and amendments, informed consent forms, IND/NDA components, and briefing packages., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Lena%20Randhawa-1.jpg',altText='Lena Randhawa-1',fileId=182849417502}, lastname=Randhawa, hs_initial_published_at=1731697233687, hs_created_by_user_id=26433386, hs_created_at=1731697009126, hs_is_edited=false, hs_deleted_at=0, name=Lena, job=Senior Manager, Medical Writing, slug=lena-randhawa, hs_updated_by_user_id=26433386}, second={}, third={}})
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    Lena Randhawa

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Read: Webinar Insights: Optimizing Cohort Management in Early-Phase Oncology Trials Webinar Insights: Optimizing Cohort Management in Early-Phase Oncology Trials

Clinical Trials - Oncology

Webinar Insights: Optimizing Cohort Management in Early-Phase Oncology Trials

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    Rob M.

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    Niveda R.

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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.