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Clinical Trials

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  • Read: Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM) Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM)

    Clinical Trials

    Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM)

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1748379090824, description=Kurt Preugschat has over 11 years of statistical experience from Phase I to Phase IV clinical trials. He is a lead statistician, providing statistical support and oversight for numerous clinical trials associated with new drug applications (NDA), supplemental new drug applications (sNDA), and medical devices. His expertise includes the development of study designs to meet complex clinical questions and the measurement of desired outcomes. In addition, Kurt has extensive experience generating statistical analyses and creating complex SAS programs and macros used by study team., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_initial_published_at=1716136551646, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
    • Kurt Preugschat avatar

      Kurt Preugschat

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  • Read: Phase I Clinical Trial Designs: Bayesian Logistic Regression Model (BLRM) Phase I Clinical Trial Designs: Bayesian Logistic Regression Model (BLRM)

    Clinical Trials

    Phase I Clinical Trial Designs: Bayesian Logistic Regression Model (BLRM)

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1748379090824, description=Kurt Preugschat has over 11 years of statistical experience from Phase I to Phase IV clinical trials. He is a lead statistician, providing statistical support and oversight for numerous clinical trials associated with new drug applications (NDA), supplemental new drug applications (sNDA), and medical devices. His expertise includes the development of study designs to meet complex clinical questions and the measurement of desired outcomes. In addition, Kurt has extensive experience generating statistical analyses and creating complex SAS programs and macros used by study team., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_initial_published_at=1716136551646, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
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      Kurt Preugschat

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  • Read: Why 100% SDV Is No Longer Feasible — and How Risk-Based Monitoring Saves Time, Money, and Your Trial Why 100% SDV Is No Longer Feasible — and How Risk-Based Monitoring Saves Time, Money, and Your Trial

    Clinical Trials

    Why 100% SDV Is No Longer Feasible — and How Risk-Based Monitoring Saves Time, Money, and Your Trial

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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=1748379090824, 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={hs_id=190691157084, hs_child_table_id=0, hs_updated_at=1748379058655, hs_published_at=1748379090824, description=Over the last 15 years, Megan has played a key role in advancing multiple oncology compounds through various stages of development, across numerous tumor types. Having worked at both biotech and CRO companies, Megan brings a comprehensive understanding of clinical operations and drug development. Megan maintains a focus on accelerating the development of innovative cancer therapies to improve patient outcomes worldwide., avatar=Image{width=3024,height=4032,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Megan%20Knoch.jpg',altText='Megan Knoch',fileId=190688034156}, lastname=Knoch, hs_initial_published_at=1748379090824, hs_created_by_user_id=26433386, hs_created_at=1748379018316, hs_is_edited=false, hs_deleted_at=0, name=Megan, slug=megan-knoch, hs_updated_by_user_id=26433386}, third={}})
    • Christine L. avatar

      Christine L.

    • Megan K. avatar

      Megan K.

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  • Read: Four Critical Questions to Ask Before Signing with a ‘Big Five’ CRO Four Critical Questions to Ask Before Signing with a ‘Big Five’ CRO

    Clinical Trials

    Four Critical Questions to Ask Before Signing with a ‘Big Five’ 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=1748379090824, 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: Defaulting to a Big Five CRO? Here’s What Sponsors Wish They Knew First Defaulting to a Big Five CRO? Here’s What Sponsors Wish They Knew First

    Clinical Trials

    Defaulting to a Big Five CRO? Here’s What Sponsors Wish They Knew First

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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=1748379090824, 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={}})
    • Rob Maiale avatar

      Rob Maiale

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  • Read: Study Start-Up vs Site Start-Up in Clinical Research: Understanding Modern Trial Dynamics Study Start-Up vs Site Start-Up in Clinical Research: Understanding Modern Trial Dynamics

    Clinical Trials

    Study Start-Up vs Site Start-Up in Clinical Research: Understanding Modern Trial Dynamics

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=169565849890, hs_child_table_id=0, hs_updated_at=1723217327146, hs_published_at=1748379090824, avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Barbara%20Kathage.jpg',altText='Barbara Kathage',fileId=168426405902}, lastname=Kathage, hs_initial_published_at=1718988967067, hs_created_by_user_id=26433386, hs_created_at=1717603865843, hs_is_edited=false, hs_deleted_at=0, name=Barbara, job=Vice President, Site Start Up, slug=barbara-kathage, hs_updated_by_user_id=51739740}, second={}, third={}})
    • Barbara Kathage avatar

      Barbara Kathage

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  • 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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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1748379090824, description=Industry-leading oncologist and demonstrated medical leader in precision medicine, novel trial design and innovative regulatory initiatives designed to expedite drug approvals. Draws on nearly a decade leading oncology and rare disease programs at the FDA. Former fellow at the National Cancer Institute and frequent featured speaker at ASCO and AACR. CDER technical authority on oncologic drug and biological products for thoracic and head and neck malignancies, neurologic tumors, pediatric solid tumors and rare tumors., avatar=Image{width=553,height=580,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Harpreet-Singh2.png',altText='Harpreet-Singh2',fileId=171747124346}, linkedin=https://www.linkedin.com/in/harpreetsinghmd/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Singh, MD, hs_initial_published_at=1715692570942, hs_created_by_user_id=2737751, hs_created_at=1715692477118, hs_is_edited=false, hs_deleted_at=0, name=Harpreet, job=Chief Medical Officer, slug=harpreet-singh, hs_updated_by_user_id=51739740}, second={}, third={}})
    • Harpreet Singh, MD avatar

      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=1748379090824, 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={}})
    • Rob Maiale avatar

      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=1748379090824, 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={}})
    • Christine Lusk avatar

      Christine Lusk

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