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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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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)

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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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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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