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}})
Hidden Strategic Edge in Clinical Trials: Financial Project Management
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Why Global Oncology Evidence May Not Support U.S. Regulatory Approval
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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=1787135938204, 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=92535535}, second={}, third={}})
Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=164713188870, hs_child_table_id=0, hs_updated_at=1754641424769, hs_published_at=1787135938204, description=Deana Demjen is Director of the Precision Site Network, bringing nearly 20 years of clinical research to the role. Most of her previous experience has been in feasibility and site-identification. She has been covering a wide range of therapeutic areas, but her main focus are rare diseases where she is an acting subject matter expert. She is responsible for relationships with PSN sites as well as the maintenance and expansion of the network., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Deana-Demjen-1.png',altText='Deana-Demjen-1',fileId=194123711869}, lastname=Demjen, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713363112834, hs_is_edited=false, hs_deleted_at=0, name=Deana, job=Director of PSN, slug=deana-demjen, hs_updated_by_user_id=92535535}, second={}, third={}})
has third author: false, (SizeLimitingPyMap: {main={hs_id=199521241215, hs_child_table_id=0, hs_updated_at=1774887081250, hs_published_at=1787135938204, description=An industry veteran with nearly three decades of experience in the clinical research industry and deep expertise in clinical operations and strategic leadership across both pharmaceutical and CRO environments. Held pivotal roles as Head of Clinical Operations for Greater China at Boehringer Ingelheim, leading trials in oncology, respiratory, stroke, and cardio-metabolic diseases and CEO of George Clinical, a global CRO with strong scientific capabilities in renal and oncology therapeutic areas. At Precision for Medicine, a leader for business strategy across the Asia Pacific region. Focused on driving regional growth, building strategic partnerships, and supporting excellence in portfolio delivery and client satisfaction. An acknowledged driver of precision-driven solutions that improve patient outcomes., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/James%20Cheong.png',altText='James Cheong',fileId=199519079710}, linkedin=https://www.linkedin.com/in/james-cheong-36a543a/, lastname=Cheong, hs_initial_published_at=1762885727645, hs_created_by_user_id=78347666, hs_created_at=1762885637470, hs_is_edited=false, hs_deleted_at=0, name=James, job=Senior Vice President, Asia Pacific, Clinical Solutions, slug=james-cheong, hs_updated_by_user_id=92535535}, second={hs_id=199519203221, hs_child_table_id=0, hs_updated_at=1770145994248, hs_published_at=1787135938204, description=Highly accomplished global clinical operations executive with nearly three decades of experience providing strategic leadership, regional expansion, and operational excellence across Asia Pacific. Brings deep expertise across clinical development, project and portfolio operations, biometrics, regulatory affairs, safety and pharmacovigilance, quality management, and financial governance. Proven builder and scaler of high‑performing teams and start‑up operations in both regional and global environments. Recognized industry leader who actively contributes to advancing clinical research standards through advisory and governance roles across Asia., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Jing%20Ping%20Yeo.png',altText='Jing Ping Yeo',fileId=199530854290}, linkedin=https://www.linkedin.com/in/jing-ping-yeo/, lastname=Yeo, PhD , hs_initial_published_at=1762893310168, hs_created_by_user_id=78347666, hs_created_at=1762893091367, hs_is_edited=false, hs_deleted_at=0, name=Jing Ping, job=Vice President, Clinical Operations, Head of Asia Pacific, slug=JingPing-Yeo, hs_updated_by_user_id=92535535}, third={hs_id=199528025104, hs_child_table_id=0, hs_updated_at=1774885968488, hs_published_at=1787135938204, description=With 20+ years of experience in the clinical trial industry, he has led project management, clinical operations, and business development teams. Prior to joining Precision, he served as the General Manager of Emerald (formerly George Clinical) China, and held project management and business development leadership roles at ICON, WuXi CDS, IQVIA, and KUNTUO. He has successfully led teams to complete more than 120 Phase I–IV clinical trials, many of which were MRCT studies across Asia‑Pacific, Australia, and the United States. He holds a Master’s degree in Urology from Peking University First Hospital., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Zhenfei%20Yin.png',altText='Zhenfei Yin',fileId=199530854553}, lastname=Yin, hs_initial_published_at=1762893310168, hs_created_by_user_id=78347666, hs_created_at=1762893190542, hs_is_edited=false, hs_deleted_at=0, name=Zhenfei, job=China Country Head, Senior Director, Project Management, slug=Zhenfei Yin, hs_updated_by_user_id=92535535}})
Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions
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has third author: false, (SizeLimitingPyMap: {main={hs_id=214928090133, hs_child_table_id=0, hs_updated_at=1781285625399, hs_published_at=1787135938204, description=Deborah Spencer is a Senior Director of Project Management at Precision for Medicine with over 25 years of experience in clinical research. She specialises in leading global clinical trials across multiple phases, with deep expertise in complex study delivery. Deborah provides strategic oversight of programmes, leads high-performing teams, and partners closely with sponsors to ensure successful execution and regulatory readiness., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Deborah%20Spencer.jpg',altText='Deborah Spencer',fileId=214838919278}, lastname=Spencer, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285562019, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job=Senior Director, Project Management, slug=deborah-spencer, hs_updated_by_user_id=92535535}, second={hs_id=214928170660, hs_child_table_id=0, hs_updated_at=1781285676367, hs_published_at=1787135938204, description=Anthea Gates is a Project Director with approximately 30 years of drug development and medical device industry expertise across all phases, over a variety of indications including breast, lung cancer, solid tumors and lymphoma, cutaneous T-cell lymphoma, malignant melanoma, squamous cell carcinoma, rare haematologic disease, autoimmune rheumatology, osteoarthritis, ocular burns, liver cirrhosis, myopia and pre-eclampsia. Committed to delivering quality and passionate about building positive relationships with clients and study teams to promote cohesive business practices and ensure the successful management of projects from start to finish. Anthea holds a proven track record in effective leadership of cross-functional teams across programs of studies, to the accomplishment of operational excellence., avatar=Image{width=372,height=546,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/profile.jpg',altText='profile',fileId=214846873938}, lastname=Gates, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285639221, hs_is_edited=false, hs_deleted_at=0, name=Anthea, job=Project Director, slug=anthea-gates, hs_updated_by_user_id=92535535}, third={hs_id=214928090141, hs_child_table_id=0, hs_updated_at=1781285738567, hs_published_at=1787135938204, description=Claire Delaville is a Senior Project Manager at Precision for Medicine. She brings 18 years of experience across preclinical and clinical research, including more than a decade leading Phase I to IV studies in oncology, rare diseases, and immunology, with direct experience in first-in-human and multicenter oncology trials. Claire is responsible for maintaining study quality through inspection readiness, corrective action planning, and proactive risk mitigation. She also oversees study budgets and vendor performance to support coordinated delivery across functions, drawing on a scientific foundation that includes a PhD in Neurosciences and Neuropharmacology. Based in Paris, France, Claire aligns scientific insight with operational execution to support successful trial outcomes., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Claire%20Delaville.jpg',altText='Claire Delaville',fileId=214838927033}, lastname=Delaville, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285678112, hs_is_edited=false, hs_deleted_at=0, name=Claire, job=Senior Project Manager, slug=claire-delaville, hs_updated_by_user_id=92535535}})
Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=213698206365, hs_child_table_id=0, hs_updated_at=1780680681226, hs_published_at=1787135938204, description=Rui F. Duarte‑Lopes is a senior biostatistics leader with over 31 years of international experience across biopharmaceutical, biotechnology, and CRO sectors. He provides strategic statistical oversight, ensuring rigorous, high‑quality, and decision‑focused delivery aligned with sponsor and regulatory expectations. He has more than 12 years of CRO experience supporting Phase I–IV clinical trials and has held roles including Lead Statistician, Project Lead, and Senior Manager. His therapeutic experience includes oncology and autoimmune diseases, notably lupus erythematosus, Crohn's disease and rheumatoid arthritis. Specializing in oncology over the past six years, Rui focuses on advanced solid tumors and early‑phase studies, contributing to study design, interim analyses, and data‑driven decision frameworks., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Rui%20F%20Duarte-Lopes.jpg',altText='Rui F Duarte-Lopes',fileId=213695319705}, lastname=Duarte-Lopes, hs_initial_published_at=1779886328878, hs_created_by_user_id=26433386, hs_created_at=1779886165792, hs_is_edited=false, hs_deleted_at=0, name=Rui F, job=Senior Manager, Biostatistics, slug=rui-f-duarte-lopes, hs_updated_by_user_id=92535535}, second={}, third={}})
China’s New Drug Regulatory Framework Positions the Country as a Global Hub for Innovative Medicine Launches
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=209983237513, hs_child_table_id=0, hs_updated_at=1774533604788, hs_published_at=1787135938204, description=Calvin Niu received his BD in pharmaceuticals from Lanzhou University. He has brought over 22 years of drug development and regulatory experience in pharmaceutical companies and CROs. Calvin’s regulatory expertise covers regulatory agency engagements and all types of regulatory submissions throughout product development and post market life cycles in oncology, immunology, ophthalmology, clinical nutrition, cardiovascular, gastroenterology, women’s health, CNS, rare disease, etc. , avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Calvin%20Niu.png',altText='Calvin Niu',fileId=209991702802}, lastname=Niu, hs_initial_published_at=1774533614867, hs_created_by_user_id=51739740, hs_created_at=1774531720533, hs_is_edited=false, hs_deleted_at=0, name=Calvin, job=Director, Regulatory Affairs, China, slug=calvin-niu, hs_updated_by_user_id=92535535}, second={}, third={}})
Bringing Early Phase Oncology Closer to Patients in Los Angeles
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1754641583843, hs_published_at=1787135938204, 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=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/rob.png',altText='rob',fileId=194099000843}, linkedin=https://www.linkedin.com/in/rob-maiale/, hs_name=, hs_path=, lastname=Maiale, hs_initial_published_at=1775839468505, 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=92535535}, second={}, third={}})
