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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 Cell Phenotyping by Epiontis ID –
         * Cytokine Profiling –
         * Gene Expression Profiling –
         * ELISpot and FluoroSpot –
         * Custom Assays –
         
         
     * 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.
           
           * 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.
         
         
     * 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 –
         
         
     * 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
         
         
     * 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
         
         
     * 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
             
             Computational Biology
             
             
             Domain experts from our QuartzBio team utilize integrated and
             harmonized data and tailored AI solutions to drive preclinical and
             clinical development, including patient stratification, signature
             development, predictive modeling of drug response, and MOA
             characterization.
         
         
     * Biostatistics
     * Clinical Data Management
     * Biometrics
     * QuartzBio –
         
         
       * * Biomarker Data Management –
           * 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 –
         
         
     
     
 * 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: Rarefied Thinking – Key Learnings From ~200 Rare Projects

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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
 * ESG Policy
 * Regulatory Information


NEWS & INSIGHTS

 * Publications
 * Case Studies
 * Thought Leadership
 * News
 * Events

© 2023 Precision Medicine Group, LLC. All rights reserved. Privacy Policy 
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