has not third author: true, (SizeLimitingPyMap: {main={}, second={}, third={}})
.jpg)
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
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.
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.
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.
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.
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.
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.
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.
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.
Case Study: How Monitoring Caught a Silent PK Crisis in a CAR T Rescue
What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs
has third author: false, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1772549698856, description=John is an experienced regulatory affairs consultant with more than 15 years of professional experience in drug development. He brings a proven track record in providing regulatory strategy, regulatory document development and review, and liaising with regulatory authorities., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/John%20McIntyre.png',altText='John McIntyre',fileId=201584594055}, lastname=McIntyre, PhD, hs_initial_published_at=1757516163742, hs_created_by_user_id=26433386, hs_created_at=1757515873736, hs_is_edited=false, hs_deleted_at=0, name=John, job=Senior Director, Regulatory Strategy, slug=john-mcintyre, hs_updated_by_user_id=26433386}, second={hs_id=195821592097, hs_child_table_id=0, hs_updated_at=1757598947835, hs_published_at=1772549698856, description=An expert in hematology and oncology and a veteran of the FDA with almost nine years of experience, culminating as a Deputy Director for the Division of Hematologic Malignancies 2. Possesses a profound understanding of regulatory strategy, particularly in the development of CAR-T cell therapies, bispecifics and T-cell engagers. Spearheaded initiatives to develop novel endpoints in blood cancer such as minimal residual disease (MRD) in lymphoma and chronic lymphocytic leukemia (CLL.), avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Nicholas%20Richardson.png',altText='Nicholas Richardson',fileId=195817841672}, linkedin=https://www.linkedin.com/in/nicholas-richardson-do-mph-049784113/, team=[{id=163080551773, name='Clinical Solutions Leadership'}], lastname=Richardson, DO, MPH, hs_initial_published_at=1757528527317, hs_created_by_user_id=51739740, hs_created_at=1757528274871, hs_is_edited=false, hs_deleted_at=0, name=Nicholas, job=Vice President, Clinical Development, slug=nicholas-richardson-clinical-solutions, hs_updated_by_user_id=26433386}, third={hs_id=178046423372, hs_child_table_id=0, hs_updated_at=1754641388766, hs_published_at=1772549698856, description=Rosamund (Roz) Round is a seasoned expert in patient engagement and innovation bringing over 20 years of experience. She is focused on listening to and learning from patients and care partners to understand how to better improve trial access and experience. Roz successfully built and led decentralized clinical trials service through the pandemic and is now addressing the implementation of AI across various aspects of clinical research. She has a strong focus on diversity, equity, and inclusion (DEI) to drive health equity in clinical research. Roz holds an MSc in Health Psychology, studied Psychology and Immunology at Harvard University, and is a recognized thought leader with an extensive portfolio of publications, conference presentations, webinars, and vlogs., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Round-Rosamund.png',altText='Round-Rosamund',fileId=194123714174}, lastname=Round, hs_initial_published_at=1725972637852, hs_created_by_user_id=51739740, hs_created_at=1725972446462, hs_is_edited=false, hs_deleted_at=0, name=Rosamund, job=Vice President, PAtient Engagement & Innovation, slug=rosamund-round, hs_updated_by_user_id=26433386}})
Case Study: Scaling a First Line NSCLC Trial in a Hesitant Market
has not third author: true, (SizeLimitingPyMap: {main={hs_id=208638641305, hs_child_table_id=0, hs_updated_at=1772549693775, hs_published_at=1772549698856, description=Lisa is a Director, Project Management who has been with Precision since Jan 2019. Lisa has over 18 years of clinical research experience, with a proven track record in leading cross-functional teams across programs of studies. Lisa is a collaborative communicator capable of cultivating key relationships focused on customer satisfaction. In 2018, Lisa was granted the CEO Excellence Award for exceptional project management., avatar=Image{width=378,height=339,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Lisa%20Lopez_Headshot.jpg',altText='Lisa Lopez_Headshot',fileId=208044988231}, lastname=Lopez, hs_initial_published_at=1772549698856, hs_created_by_user_id=26433386, hs_created_at=1772549635830, hs_is_edited=false, hs_deleted_at=0, name=Lisa, job=Director, Project Management, slug=lisa-lopez, hs_updated_by_user_id=26433386}, second={hs_id=208600974006, hs_child_table_id=0, hs_updated_at=1772549671531, hs_published_at=1772549698856, description=Adrien (Ash) Mtibaa, MD is a clinical research leader with 10+ years of experience in global clinical trials and deep expertise in Site Start‑Up (SSU). Currently Manager, Site Start‑Up at Precision for Medicine, he leads and mentors global SSU teams with a strong focus on process improvement, SSU strategy, leadership influence, and line management. A trained Medical Doctor, Adrien brings a pragmatic, results‑driven approach to driving activation readiness, operational excellence, and cross‑functional alignment across multi‑regional studies., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Adrien%20Mtibaa%2c%20MD.jpg',altText='Adrien Mtibaa, MD',fileId=208642032927}, lastname=Mtibaa, MD, hs_initial_published_at=1772549611983, hs_created_by_user_id=26433386, hs_created_at=1772488816847, hs_is_edited=false, hs_deleted_at=0, name=Adrien, job=Manager, Site Start Up, slug=adrien-mtibaa, hs_updated_by_user_id=26433386}, third={}})
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.
-
Discover Explore
Global CRO
ServicesAward-winning CRO with deep oncology and rare disease expertise
-
Discover Explore
Global Laboratory
ServicesExceptional translational and biomarker sciences with global central lab services
-
Discover BiospecimensBiospecimens
-
Discover Diagnostics & CDxDiagnostics & CDx
-
Discover Data IntelligenceData Intelligence
-
Discover CommercializationCommercialization
.jpg?width=1440&height=460&name=iStock-1346401663%20(1).jpg)