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Medical device and IVD studies demand a shared commitment

We have proven expertise critical to the successful development, validation, and commercialization of in vitro diagnostics and share your commitment to scientific rigor, patient safety, and regulatory compliance. 
Lab technician scanning a test tube label while conducting a blood test

Lab expertise

World class scientific leaders and program engagement

-  Principle investigator

-  Program Manager

-  Pathology experts

-  LM

 

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From analytical validation through commercialization

Our team understands the unique requirements and needs of an FIM/feasibility, pivotal or post-market study and have experience managing studies across all therapeutic areas and phases.

Full-service labs with routine and esoteric testing, broad testing menus

  • Anatomic Pathology (PP)
  • Chemistry
  • Coagulation
  • Cytogenetics
  • FISH/ISH/IHC 
  • Flow Cytometry 
  • Hematology
  • Immunology
  • Infectious Diseases
  • Microbiology
  • Molecular Genetics
  • Molecular Infectious Disease
  • and more

Facilities available

Industry leading facilities

Open-floor and flexible lab facilities
        -  140,000 square feet available
        -  Centrally located
        -  Labs available in close vicinity

X# of labs operating X# of platforms and more than X# instruments

From analytical validation through commercialization

Our team understands the unique requirements and needs of an FIM/feasibility, pivotal or post-market study and have experience managing studies across all therapeutic areas and phases.

Full-service labs with routine and esoteric testing, broad testing menus

  • Anatomic Pathology (PP)
  • Chemistry
  • Coagulation
  • Cytogenetics
  • FISH/ISH/IHC 
  • Flow Cytometry 
  • Hematology
  • Immunology
  • Infectious Diseases
  • Microbiology
  • Molecular Genetics
  • Molecular Infectious Disease
  • and more

Sample management

High-quality sample collection and processing services

-  Mobile specimen collection
-  Biorepository/sample storage
-  Remnant samples available
-  Kitting operations
An image of a laboratory professional holding a test tube filled with blood.

From analytical validation through commercialization

Our team understands the unique requirements and needs of an FIM/feasibility, pivotal or post-market study and have experience managing studies across all therapeutic areas and phases.

Full-service labs with routine and esoteric testing, broad testing menus

  • Anatomic Pathology (PP)
  • Chemistry
  • Coagulation
  • Cytogenetics
  • FISH/ISH/IHC 
  • Flow Cytometry 
  • Hematology
  • Immunology
  • Infectious Diseases
  • Microbiology
  • Molecular Genetics
  • Molecular Infectious Disease
  • and more

Predicate devices

Access to a broad array of predicate devices

High volumes of positive and negative controls

From analytical validation through commercialization

Our team understands the unique requirements and needs of an FIM/feasibility, pivotal or post-market study and have experience managing studies across all therapeutic areas and phases.

Full-service labs with routine and esoteric testing, broad testing menus

  • Anatomic Pathology (PP)
  • Chemistry
  • Coagulation
  • Cytogenetics
  • FISH/ISH/IHC 
  • Flow Cytometry 
  • Hematology
  • Immunology
  • Infectious Diseases
  • Microbiology
  • Molecular Genetics
  • Molecular Infectious Disease
  • and more

We ask the right questions along the way:

  • What test modality should be used to maximize test and drug access?
  • What FDA pathway is most favorable for the test?
  • Does the test modality/biomarker align with a commercialization strategy?
  • How will the test result be used to control drug access? (cutoff)
  • What about the turnaround time, sample type, access?
  • Are you planning on bridging studies or doing a co-development?
  • What parameters are needed for a validated assay?
  • Do you need a companion diagnostic? Or a complementary diagnostic? Or a laboratory developed test (LDT)?

Our team can help you determine key elements of your development process:

  • Defining the biomarker (eg, specific variants, proteins, antibodies)
  • Selecting the biomarker analyte (eg, DNA, RNA, protein, IgG)   
  • Selecting the specimen type (eg, serum, saliva, tissue)
  • Selecting the technology (eg, next generation sequencing (NGS), polymerase chain reaction (PCR), immunohistorychemistry (IHC), enzyme-linked immunoassay (ELISA))
  • Selecting the cutoff (eg, number)

Our team can help you determine key elements of your development process:

  • Defining the biomarker (eg, specific variants, proteins, antibodies)
  • Selecting the biomarker analyte (eg, DNA, RNA, protein, IgG)   
  • Selecting the specimen type (eg, serum, saliva, tissue)
  • Selecting the technology (eg, next generation sequencing (NGS), polymerase chain reaction (PCR), immunohistorychemistry (IHC), enzyme-linked immunoassay (ELISA))
  • Selecting the cutoff (eg, number)

We ask the right questions along the way:

  • What test modality should be used to maximize test and drug access?
  • What FDA pathway is most favorable for the test?
  • Does the test modality/biomarker align with a commercialization strategy?
  • How will the test result be used to control drug access? (cutoff)
  • What about the turnaround time, sample type, access?
  • Are you planning on bridging studies or doing a co-development?
  • What parameters are needed for a validated assay?
  • Do you need a companion diagnostic? Or a complementary diagnostic? Or a laboratory developed test (LDT)?

Let's discuss your project

Contact our pharma solutions experts to design a custom program to accommodate the needs of your study.

Let's talk