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FDA Veteran Paz Vellanki, MD, joins Precision to become one of 3 ex-FDA oncology leaders supporting clients

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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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Translational Research - Assays

Case Study: Rapid Execution of Assay Validation Rescued Global Study

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=219184495938, hs_child_table_id=0, hs_updated_at=1786473626295, hs_published_at=1787135938204, description=Christie Bongel is a scientist by training, but her true passion lies in leadership, particularly in building leaders and shaping high-performing, trust-based cultures. She believes that many talented bench scientists are promoted into management roles without formal leadership development and is committed to helping close that gap. While culture and people development may not always appear on a balance sheet, she views them as essential drivers of long-term organizational success. As a leadership-focused operations executive, Christie leads laboratory operations and strategy within a global network, partnering with pharmaceutical and biotechnology organizations to navigate complex oncology challenges. Her work spans translational oncology, clinical trial strategy, and laboratory execution, with a focus on translating scientific and operational complexity into clear, actionable strategies that drive meaningful outcomes., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/1781614819314.png',altText='Christie Bongel',fileId=219203862915}, lastname=Bongel, hs_initial_published_at=1786473638412, hs_created_by_user_id=65712240, hs_created_at=1786473568408, hs_is_edited=false, hs_deleted_at=0, name=Christie, job=Site Director, slug=christie-bongel, hs_updated_by_user_id=92535535}, second={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1787135938204, 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=92535535}, third={}})
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    Christie B.
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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}})
  • Zulfat K. avatar Shakila J. avatar Sugumaran M. avatar

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=218300089344, hs_child_table_id=0, hs_updated_at=1785358312044, hs_published_at=1787135938204, description=Global Finance leader with 35+ years of progressive experience and over two decades in the global CRO industry. Proven track record of building and developing high-performing teams, leading complex financial operations, and driving strategic initiatives that improve business performance and scalability. Deep expertise in financial planning and analysis, contract negotiation, budgeting and forecasting, process optimization, auditing, cash flow management, and credit and collections. Passionate about fostering collaboration across finance, operations, and executive leadership to deliver data-driven insights, strengthen governance, and enable informed decision-making both internally and for our Sponsors., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/1576750031793.jpeg',altText='1576750031793',fileId=218305569797}, lastname=Kane, hs_initial_published_at=1785358316248, hs_created_by_user_id=65712240, hs_created_at=1785358281109, hs_is_edited=false, hs_deleted_at=0, name=Romy, job=Vice President, Operational Finance, slug=romy-kane, hs_updated_by_user_id=92535535}, second={}, third={}})
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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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