Seeking CRAs who are looking to have influence and impact when it matters most. Clinical Research Associate, Northern Ireland: https://lnkd.in/ejgAWy3i Clinical Research Associate, UK: https://lnkd.in/ec4K2PVz
About us
Precision for Medicine is an industry-leading global clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. This maximizes our clients’ insight into patient biology, delivering more predictable trial outcomes and accelerating clinical development. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.
- Website
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http://www.precisionformedicine.com
External link for Precision For Medicine
- Industry
- Biotechnology Research
- Company size
- 1,001-5,000 employees
- Headquarters
- Bethesda, MD
- Type
- Privately Held
- Specialties
- Global Clinical Trial Services, Specialty Lab Services, Translational Science, Clinical Data Management, Biostatistics, Biomarker Strategies, Sample Sourcing and Storage, Immune Monitoring, IVD Development, CDx Development, Market Access, IVD CRO, Regulatory Strategy and Submission, and Contract Research Organization
Locations
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Primary
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2 Bethesda Metro Center
Suite 850
Bethesda, MD 20814, US
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8425 Progress Drive
Fredrick, MD 21701, US
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55 Cambridge Parkway
Ste 300E
Cambridge, MA 02142, US
Employees at Precision For Medicine
Updates
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Biomarker-driven enrollment can make or break a precision oncology trial. For rare cancers like adenoid cystic carcinoma (ACC), success depends on more than patient identification. Sites must be NGS-ready, regulators must be aligned, and every screen failure carries weight. This Phase 2 trial targeting Notch mutations shows how thoughtful design, early vendor activation, and pre-screening strategy turned potential bottlenecks into an advantage. https://lnkd.in/e_6ZX8_A
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When she was diagnosed with Breast Cancer, Cara King, MPH, Senior Clinical Trial Manager, suddenly became the patient. She counsels anyone diagnosed with cancer to take advantage of every resource available to them—and to give themselves grace as they navigate frightening new territory. #BCAM2025 #CancerScreening #BreastCancerSurvival #Healthcare #Oncology
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Don’t let new FDA guidance add uncertainty to your development plans. Watch this short video by our CMO and former FDA Oncology Division Director Harpreet Singh, MD to learn strategies for making sense of new regulatory guidance and using them to accelerate your development progress.
It was a pleasure speaking with Targeted Oncology about the FDA’s draft guidance on radiopharmaceutical dosing released earlier this year. In this short video, I share why an FDA-informed perspective is critical when interpreting and applying new guidance for industry. This guidance reflects a major step forward in how the agency is thinking about radiopharmaceuticals, recognizing that these therapies are fundamentally different from external beam radiation and deserve their own framework for dose justification and safety monitoring. These documents outline expectations, but understanding where there is appropriate flexibility, and how to leverage that based on the science, is where real progress happens. That’s where having someone who’s been on the other side of the table matters. Someone to help read between the lines, anticipate regulatory perspectives, and help developers engage FDA with confidence. Watch the full interview for more insights on what this guidance means for radiopharma. Precision For Medicine #Radiopharmaceuticals #FDAGuidance #RegulatoryScience
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Whether you're planning your next clinical trial or exploring innovative solutions, we're here to help. Let’s talk strategy, science, and success. Meet the Precision for Medicine team at Booth 21 in Boston, October 15–16: Stephen DeFusco, Tina Patel and Chris James.
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Introducing Precision’s Matched Set Biospecimens! Access matched tissue and blood samples from the same person, enabling deeper insights into disease biology and biomarker discovery. Using high-quality matched set biospecimens de-risks research programs by reflecting true tumor biology and minimizing false positives and failed validation studies. •Every matched specimen is reviewed by a board-certified pathologist and backed by clinical, regulatory, and laboratory expertise •All samples are consented and compliant with global regulations •Access ready-to-ship inventory across 15+ cancer types or launch custom collections through our global clinical network Unlock new insights with our matched set biospecimens: https://lnkd.in/emjYQqhP
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From first conversation to final database lock, we show up where it matters. In the months ahead, our team will be looking to start new conversations at leading clinical research conferences across Europe, North America, and Asia-Pacific. We’re connecting with sponsors, collaborators, and the people pushing advanced therapies forward. Will our paths cross? Check the carousel below to see where we’ll be. Speak with our experts to give your program the support it deserves.
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Precision is heading to #ESMO2025 in Berlin! Among our team of global clinical trial experts there will be 阴振飞 Zhenfei Yin, our China Country Head. He will be onsite to connect with biotech and biopharma partners looking to expand their clinical trials into APAC. Use this link to schedule a meeting with Zhenfei or any of our SMEs at ESMO: https://lnkd.in/gJcF9nGm #ESMO #PrecisionforMedicine #Oncology #ClinicalResearch #Biotech #AsiaPacific #China
Meet me at ESMO to learn about PFM’s Clinical Solutions offerings in China and the APAC region! https://lnkd.in/gJcF9nGm #ESMO #ClinicalTrials #China #APAC
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Cell and gene therapy development in small populations just got a green light to accelerate. With the latest FDA CGT guidance, sponsors can tap into Fast Track, Breakthrough, RMAT, Priority Review, and Accelerated Approval processes to streamline development. The new framework endorses a fit-for-purpose approach that will allow much needed therapies to advance faster while maintaining rigorous quality controls.
Vice President, Clinical Development (Hematology, Oncology, Cell & Gene), Precision for Medicine
FDA's Center for Biologics Evaluation and Research (CBER) has issued draft guidance on innovative clinical trial designs for cell and gene therapies in small populations. The document details considerations for designing robust trials in small populations when traditional randomized trials are constrained. The guidance provides valuable insights into: - Single-arm trials where patients serve as their own control - Quantitative disease-progression modeling - External controls using historical or real-world data - Adaptive designs that allow interim-based modifications - Bayesian methods that integrate external data including potential sample-size reductions - Master protocols including platform, umbrella, and basket trials For CGT sponsors in rare and serious conditions, the framework provides a fit-for-purpose approach to generate rigorous, actionable evidence. I look forward to helping developers navigate this evolving landscape and ensure innovation translates into meaningful clinical impact. #FDAGuidance #CBER #CGTDevelopers #InnovativeTrialDesign
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Every cancer journey is unique, as Ada Middleton, Senior Innovation Director, Clinical Solutions, Precision For Medicine, knows all too well. She has walked the path with family, friends, and colleagues, and shares her insights here. WATCH HER STORY. #BCAM2025 #CancerScreening #BreastCancerSurvival #Healthcare #Oncology #PrecisionInPink