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Precision Drug Safety and Pharmacovigilance Services

Safeguarding patient health with proactive and rigorous monitoring and reporting
 At Precision for Medicine, we navigate the complexities of drug safety and pharmacovigilance with unparalleled expertise and advanced technology. Our commitment to excellence ensures regulatory compliance and patient safety across global clinical trials. As your trusted partner, we're dedicated to upholding the highest standards of care, making every decision with patient well-being and regulatory compliance in mind

Global capabilities in Drug Safety and Pharmacovigilance services

Precision for Medicine offers a spectrum of drug safety and pharmacovigilance services tailored to meet the diverse needs of our sponsors. Understanding that each clinical trial is unique, we have developed service models designed for flexibility and efficiency, ensuring that our sponsors can choose the level of support that best fits their project's scale and complexity.

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Customized solutions for every clinical phase

Whether you require comprehensive coverage for large-scale, multinational trials or targeted support for specialized studies, Precision provides. Our service models encompass everything from single case processing and periodic reporting to sophisticated analytics and full-spectrum pharmacovigilance programs.

Global Teams-Reach

A global team of experts

Our strength lies in our people. Precision's safety team—strategically distributed across the US, EU and APAC—brings together a wealth of knowledge and experience, averaging over 12 years in drug safety roles. This diverse team is not only proficient in a wide array of therapeutic areas but also deeply understands the nuances of regional and global regulatory requirements. Our integrated approach ensures consistent and reliable safety oversight, no matter where in the world your trials are conducted.

Drug safety excellence

Commitment to excellence

With a steadfast commitment to advancing patient safety and drug efficacy, Precision for Medicine stands as your dedicated partner. Our seasoned professionals, armed with extensive industry experience and an unparalleled understanding of pharmacovigilance, are ready to deliver excellence in safety services with the global reach and capability that today's complex clinical landscapes demand.

Leveraging Argus for compliance and end-to-end case management

We understand the imperative of navigating the intricate landscape of pharmacovigilance with unwavering compliance and security. Our utilization of Oracle's Argus Safety database is a testament to our commitment to providing sponsors with a seamless, secure, and comprehensive safety case management solution.

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    Unmatched Regulatory Adherence

    In an environment where regulatory demands are as dynamic as the clinical trials themselves, Precision offers peace of mind with Argus—the benchmark in meeting global compliance standards. From the moment an adverse event is captured to the detailed documentation required for regulatory submissions, our experts harness Argus's robust capabilities to ensure that every step aligns with the latest directives. Whether your trial spans one country or multiple continents, our vigilance in compliance safeguards your clinical journey.
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    Fortified Security and Confidentiality

    Your data’s integrity is paramount, which is why we anchor our drug safety operations in the secure and private infrastructure of Argus. Certified for protected health information, Argus delivers the confidentiality sponsors demand, without compromise. Our safety case management through Argus means your sensitive trial data is enveloped in a cloud of trust, meticulously managed to protect patient information and uphold the highest standards of data stewardship.
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    Comprehensive Case Management

    End-to-end case management with Argus empowers sponsors to oversee the safety profile of their products with crystal-clear clarity. From the initial intake of safety reports to the final step of data analysis and submission, Argus's intuitive platform streamlines the workflow. This integration ensures that critical safety information is captured, analyzed, and reported with precision, enabling informed decision-making and fostering proactive risk mitigation.

By integrating Argus's industry-leading platform into our pharmacovigilance services, Precision for Medicine elevates the standard for drug safety and pharmacovigilance. We offer sponsors a strategic partnership that delivers efficiency, compliance, and security—cornerstones of successful clinical trial management and the bedrock of patient safety.

Deep Expertise in Complex Diseases and Advanced Therapies

We recognize the patient journey throughout the development process. Our mission is to assist our partners in delivering innovative treatments to patients. Leverage our deep expertise in these therapeutic areas and modalities to advance your clinical goals.

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Read the latest insights on Precision’s blog

Discover expert analysis and broaden your understanding through Precision’s Insights on current research, case studies, and trends. 

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Read: Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions

Clinical Trials - Early Phase Research - Autoimmune

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=1781285742914, 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=26433386}, second={hs_id=214928170660, hs_child_table_id=0, hs_updated_at=1781285676367, hs_published_at=1781285742914, 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=26433386}, third={hs_id=214928090141, hs_child_table_id=0, hs_updated_at=1781285738567, hs_published_at=1781285742914, 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=26433386}})
  • Deborah S. avatar Anthea G. avatar Claire D. avatar

  • Deborah S.

    Anthea G.

    Claire D.
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Read: Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies

Clinical Trials

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=1781285742914, 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=26433386}, second={}, third={}})
  • Rui F Duarte-Lopes avatar

    Rui F Duarte-Lopes
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Read: Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx

Assays - Oncology

Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1781285742914, 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=26433386}, second={hs_id=164426546714, hs_child_table_id=0, hs_updated_at=1778171432595, hs_published_at=1781285742914, description=Angélique Heckmann, PhD is a people‑driven leader who combines scientific expertise and business acumen with a strong foundation in human values. With a background in therapeutic drug development and an MBA‑shaped strategic mindset, she focuses on building meaningful, long‑term relationships with teams, partners, and clients. By bridging science and strategy, she supports informed decision‑making, fosters collaboration, and helps translate innovation into real‑world impact—always guided by a shared purpose: advancing solutions that ultimately improve patients’ lives, avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/angelique-1.png',altText='angelique-1',fileId=194126030110}, lastname=Heckmann, PhD, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713172107894, hs_is_edited=false, hs_deleted_at=0, name=Angelique, job=Regional Vice President, Translational Business Solutions, slug=angelique-heckmann, hs_updated_by_user_id=26433386}, third={}})
  • Kennon D. avatar

    Kennon D.
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    Angelique H.
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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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