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* Biospecimen SolutionsPrecision Value & HealthCareers * Clinical Trial Services * * Overview * * Image Oncology Clinical Trials Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs. * Image Rare & Orphan Disease With experience built on 150+ orphan disease projects covering 80+ rare diseases, we know how to anticipate logistical and regulatory obstacles and craft bold solutions that drive rare disease development programs. * Global Clinical Trial Support * * North & South America * Image Oncology Clinical Trials Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs. * Europe * Image Oncology Clinical Trials Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs. * APAC * Image Oncology Clinical Trials Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs. * Clinical Trial Management * * Study Start-up & Feasibility * Image Oncology Clinical Trials Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs. * Project Management * Patient Recruitment * Personalized Clinical Trial Operations * Biometrics * Medical & Safety Monitoring * Clinical Data Management * Medical Writing * Clinical Development Strategy * * Clinical Development Planning * Image Oncology Clinical Trials Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs. * Biomarker Strategies * Cell & Gene Therapy Strategies * CDx Regulatory and Market Access * Clinical Trial Design * * Basket & Umbrella Trials * Image Oncology Clinical Trials Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs. * Biomarker Clinical Trials * Master Protocol Trials * Decentralized Clinical Trials * Biostatistics * * Statistical Consulting * Image Oncology Clinical Trials Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs. * Study Design * Data Monitoring Committees * CDISC Programming and Documentation * eCTD Submissions * Central Lab Services * * Clinical Specimen Kitting * Image Oncology Clinical Trials Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs. * Sample Processing * Global Specimen Logistics and Biostorage * Biospecimen Data Services * Precision Lab e-Portal * Virtual Sample Inventory Management * Training * * Image Oncology Clinical Trials Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs. * Image Rare & Orphan Disease With experience built on 150+ orphan disease projects covering 80+ rare diseases, we know how to anticipate logistical and regulatory obstacles and craft bold solutions that drive rare disease development programs. * Lab Services * * Central Lab Services * * Clinical Specimen Kitting * Image Oncology Clinical Trials Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs. * Sample Processing * Global Specimen Logistics and Biostorage * Biospecimen Data Services * Precision Lab e-Portal * Virtual Sample Inventory Management * Specialty Lab Services Overview * * Image Immune Monitoring Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology. * Image Tissue and Liquid Biopsy Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich circulating tumor cells for downstream analysis. * EU Contract Research Organization * Immune Monitoring * * Immune Monitoring by Flow Cytometry * Image Immune Monitoring Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology. * Immune Monitoring by Epiontis ID® * Cytokine Profiling * Gene Expression Profiling * ELISpot and FluoroSpot * Custom Assays * Flow Cytometry * * Receptor Occupancy Assays by Flow Cytometry * Image Immune Monitoring Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology. * Spectral Flow Cytometry * Genomics * * NanoString Assays * Image Immune Monitoring Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology. * ddPCR * qPCR * NGS * Fluorescence In Situ Hybridisation (FISH) / ISH * Single-Cell Sequencing * Tissue & Liquid Biopsy * * ApoStream – CTC and Rare Cell Isolation for Liquid Biopsy * Image Immune Monitoring Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology. * CTC / cfDNA / Exosome Analysis * Multiplex Immunofluorescence * Immunohistochemistry * Fluorescence In Situ Hybridisation (FISH) / ISH * Pathology Services * NanoString Assays * Bioanalytical Testing * * Immunogenicity Testing * Image Immune Monitoring Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology. * PK Assays * ADA Assays * MesoScale Discovery (MSD) Assays * Quanterix SIMOA * ELISA * Protein & Cytokine Analysis * * ELISA * Image Immune Monitoring Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology. * MesoScale Discovery (MSD) Assays * Luminex * Quanterix SIMOA * Automated Western Blotting * Olink® Proteomics * Preclinical Target and Biomarker Validation * * Cell Based Assays * Target Expression – XpressWay Profiles * Tissue Cross-Reactivity * Fluorescence In Situ Hybridisation (FISH) / ISH * Multiplex Immunofluorescence * Immunohistochemistry (IHC) * Biospecimens * * Image Immune Monitoring Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology. * Image Tissue and Liquid Biopsy Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich circulating tumor cells for downstream analysis. * Data Sciences * * Overview * * Image Biostatistics Seasoned biostatisticians and statistical programmers support every phase of your trial, from study design for small, rare disease trials to regulatory submissions, all backed by meticulous documentation. * Image QuartzBio® Solutions Purpose-built SaaS solutions developed to address the complex, manual, and siloed processes that exist in sample and biomarker data management by delivering innovative data-enabling technologies in a single, scalable platform. * Biostatistics * Clinical Data Management * Biometrics * QuartzBio® Solutions * * enterprise Biomarker Data Management (eBDM) * Image Biostatistics Seasoned biostatisticians and statistical programmers support every phase of your trial, from study design for small, rare disease trials to regulatory submissions, all backed by meticulous documentation. * virtual Sample Inventory Management (vSIM) * Analytics, Information, Insights, and Reporting * Diagnostics & CDx * * IVD and CDx Regulatory Affairs Consulting * Image Specialty Lab Services Our comprehensive approach starts with a foundation of expertise in key biomaker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis. * COVID-19 & Viral Panel Assays * Image Specialty Lab Services Our comprehensive approach starts with a foundation of expertise in key biomaker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis. * Biospecimens Solutions * Image Specialty Lab Services Our comprehensive approach starts with a foundation of expertise in key biomaker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis. * Diagnostic Market Access Services * Image Specialty Lab Services Our comprehensive approach starts with a foundation of expertise in key biomaker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis. * Companion Diagnostics * Therapeutic Areas * * Overview * * By Specialty Area * Image Global Clinical Trial Support Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs. * Oncology and Immuno-Oncology * Oncology Clinical Trials * Rare & Orphan Disease * Image Global Clinical Trial Support Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs. * Cell & Gene Therapy * Cell Therapy * Gene Therapy * Cell and Gene Therapy Manufacturing * CNS & Neuroscience * Image Global Clinical Trial Support Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs. * COVID-19 * AutoImmune & Allergy * Pediatric * By Research Phase * Preclinical Development * Early Phase Trials (I-IIa) * Late Phase Trials (IIb-III) * News & Insights * * Blog * * Image Blog Industry trends and best practices from Precision experts * Image Resources A searchable hub featuring the latest Precision case studies, white papers, capabilities brochures and more. * Resources * Thought Leadership * News * * Image Blog Industry trends and best practices from Precision experts * Image Resources A searchable hub featuring the latest Precision case studies, white papers, capabilities brochures and more. * Events * * Image Blog Industry trends and best practices from Precision experts * Image Resources A searchable hub featuring the latest Precision case studies, white papers, capabilities brochures and more. * About Us * * Our Passion * * Image Our Passion What we do, why we do it and the principles that guide us every day. * Image Meet Our People We are devoted professionals with deep expertise in translational science, clinical trials and data sciences. * Meet Our People * Careers * Regulatory Information * * Image Our Passion What we do, why we do it and the principles that guide us every day. * Image Meet Our People We are devoted professionals with deep expertise in translational science, clinical trials and data sciences. * Contact Us ✕ NEW Ebook: Navigating the Challenges of Central Nervous System Disease Research 1. 2. 3. 4. 5. 6. 1. 2. 3. 4. 5. 6. AS A PRECISION MEDICINE CLINICAL RESEARCH ORGANIZATION, WE HAVE BROUGHT TOGETHER NEW TECHNOLOGIES, EXPERTISE AND OPERATIONAL SCALE TO HELP THE LIFE SCIENCES IMPROVE THE SPEED, COST AND SUCCESS RATE OF BRINGING LIFE-CHANGING THERAPIES TO PATIENTS. PRECISION CONVERGENCE, THE COMBINED POWER OF TRIALS, LABS AND DATA SCIENCES TO DRIVE FASTER CLINICAL DEVELOPMENT WHAT SETS US APART IS THE WAY WE INTEGRATE CLINICAL TRIAL EXECUTION WITH DEEP SCIENTIFIC KNOWLEDGE, LABORATORY EXPERTISE, AND ADVANCED DATA SCIENCES. THIS IS PRECISION CONVERGENCE: MAXIMIZING INSIGHTS INTO PATIENT BIOLOGY AND ACCELERATING THE PACE OF SCIENTIFIC DISCOVERY AND APPROVAL. CLINICAL TRIAL SERVICES * First-in-human through regulatory approval global expertise * 2500+ dedicated professionals * Oncology, cell and gene therapy, rare and orphan disease LABORATORY SERVICES * Full portfolio of specialty assays * Custom assays to full-scale GxP and CLIA validation * Central lab services for global sample collection, processing, and logistics DATA SCIENCES * Deeper biological insights enriched by data * Innovative analytics empower critical clinical development decisions * Operational visibility and management enabled by data 500+ CLINICAL TRIALS 40 OFFICES IN NORTH AMERICA, EUROPE AND ASIA-PACIFIC 3000+ DEDICATED PROFESSIONALS “Targeted medicine is the way forward.” Gyöngyi Hatvani Senior CPM, Budapest 500+ CLINICAL TRIALS 40 OFFICES IN NORTH AMERICA, EUROPE AND ASIA-PACIFIC 3000+ DEDICATED PROFESSIONALS “Targeted medicine is the way forward.” Gyöngyi Hatvani Senior CPM, Budapest OUR REPUTATION IS BUILT ON SUCCESS IN THESE AREAS ONCOLOGY & IMMUNO-ONCOLOGY Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem-solving abilities that advance even the most challenging clinical development programs. Explore RARE & ORPHAN DISEASE With experience built on 150+ orphan disease projects covering 80+ rare diseases, we know how to anticipate logistical and regulatory obstacles and craft bold solutions that drive rare disease development programs. Explore CELL & GENE THERAPY With team members who are global thought leaders in cell and gene therapy development, Precision brings together scientific, clinical and regulatory expertise that is advancing the development of these programs as well as oncolytic viruses, cancer vaccines and radiolabeled ligands. Explore OUR NOVEL APPROACH IMPACTS MANY AREAS OF HUMAN HEALTH NEUROLOGY We combine advances in neurology biomarkers and biomarker detection technology for robust therapeutic development. Explore AUTOIMMUNE & ALLERGY As one of the top-rated clinical research companies, we support development programs with state-of-the-art immune monitoring solutions and immunogenicity testing expertise. Explore COVID-19 We are engaged in COVID-19 research with comprehensive solutions for all areas of therapeutic, vaccine and diagnostic development. Explore PEDIATRIC Advanced clinical trial design expertise and sensitive biomarker detection technologies accelerate pediatric therapeutic development. Explore COMPANION DIAGNOSTICS Our integrated clinical development, biomarker assay, regulatory strategy and commercialization capabilities deliver unique value for CDx programs. Explore DECENTRALIZED CLINICAL TRIALS We’ve built well-honed systems, processes, and relationships specific to DCTs that are ready to be applied to your trial—pandemic related or any other. The result is a full portfolio of DCT capabilities to address any challenge your trial might face. Explore PRECISION COVERS THE GLOBE, SUPPORTING TRIALS AT EVERY STAGE From early development to regulatory approval, from sea to sea, Precision is a global partner to many of the most innovative life-sciences companies in the world. Early Phase Trials Late Phase Trials Preclinical Development TRUSTED CLINICAL RESEARCH ORGANIZATION ACCREDITATIONS FDA REGISTERED Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment. * * Visit the website CLINICAL TRIAL SERVICES * Overview * Global Clinical Trial Support * Clinical Trial Management * Clinical Development Strategy * Clinical Trial Design * Biostatistics * Clinical Sample Management * Clinical Research Organization SPECIALTY LAB SERVICES * Overview * Immune Monitoring * Flow Cytometry * Genomics * Tissue & Liquid Biopsy * Bioanalytical Testing * Cytokine Analysis * Biospecimens * Sample Processing * Global Specimen Transport & Biostorage * Contract Research Organization * Bioanalysis * Neutralizing Antibody (NAb) Assays * PBMC Processing DATA SCIENCES * Overview * Biostatistics * Clinical Data Management * Biometrics * QuartzBio * Virtual Sample Inventory Management THERAPEUTIC EXPERTISE * Overview * Preclinical Development * Early Phase Trials (I-IIa) * Late Phase Trials (IIb-III) * Oncology and Immuno-Oncology * Rare & Orphan Disease * Cell & Gene Therapy * Neurology * COVID-19 * Autoimmune & Allergy * Pediatric * Companion Diagnostics ABOUT US * Our Passion * Meet Our People * Careers * Regulatory Information NEWS & INSIGHTS * Publications * Case Studies * Thought Leadership * News * Events © 2024 Precision Medicine Group, LLC. 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