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Preclinical Research
and Regulatory Services

Precision provides preclinical support from discovery to early development with a range of targeted solutions.

Our preclinical support begins with millions of healthy and disease state biospecimens along with the lab capabilities to investigate disease biology and target expression, and to develop complex biomarker assays that can be moved into the clinical phase. We also support development of clinical biomarker strategies, as well and companion diagnostics programs.

A range of solutions to chaperone your project to the clinical phase

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    Biospecimens

    • 7M+ Liquid Biospecimens
    • 3M+ Tissue Biospecimens
    • Custom Collections
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    Biomarker Discovery and Target Validation

    Identification and validation of therapeutic targets for small molecule, large molecule, and advanced therapies
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    Specialty Assay Development

    Assay development and validation for any tissue type, with 7 global labs and technologies to generate data from any sample type

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    Biomarker Strategy

    Development of biomarker plans to ensure successful clinical trial initiation

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    Companion Diagnostics Program Development

    • Early planning to develop biomarkers into clinical trial assays
    • Mapping of specific regulatory requirements
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Biospecimens to support preclinical development of therapeutics and diagnostics

 

With a biorepository of over 10 million healthy and disease-state biospecimens, along with the ability to prospectively collect virtually any specimens needed, Precision can support your therapeutic and diagnostic research needs.

 

Explore some of the biospecimen types available:

Blood, Biofluids & Derivatives Explore Tissues Explore Custom Biospecimen Collections Explore

 

Biomarker discovery and target validation

Effectively identifying and validating therapeutic targets and biomarkers are key to effective precision therapeutic development. Precision for Medicine provides a range of human tissue-based research services including IHC, mIF, cell-based assays, and genomics.

We specialize in utilizing these services for small molecule, large molecule, and advanced therapeutics (gene and cell therapies) to help you understand target expression and localization, determine tumor biology and cellular interplay, and characterize novel therapeutic entities.

Explore Biomarker and Target Validation Services

 

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Specialty assay development

Precision supports preclinical development through biomarker assay development, with a focus on large molecule bioanalysis and immunogenicity assays. Examples of our expertise include:

 

Biomarker strategy: planning for biomarker analysis in clinical trials

Proper biomarker planning impacts almost every aspect of a clinical trial. Thus, it is critical that biomarker management and clinical trial operations are fully integrated prior to the outset of any trial to ensure efficient, high-quality execution.

When planning for a clinical trial, details around the biomarker sample collection must be prospectively defined including the type of sample, sample processing and handling, the frequency of collection, and the general use parameters of the resultant data.

Effective planning for biomarker sampling impacts:

  • Informed Consent

    Informed Consent

    Informed consent since sample requirements and risks need to be included in the informed consent form (ICF)

  • Sample Kits

    Sample Kits

    Requirements for sample kits, which must be prepared and sent to sites to support proper sample collection and processing prior to enrollment of the first patient

  • eCRF

    eCRF

    Design of the electronic case report form (eCRF)

  • Site Budgets

    Site Budgets

    Site budgets since the type and frequency of the biomarker specimen collection can impact overall study fees

  • Data Management

    Data Management

    Biomarker data management to ensure data sources from multiple labs can be pulled together and combined with clinical data to optimize insights
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Companion diagnostics program development

Precision’s unmatched experience in diagnostic development takes your product from bench to bedside, starting in at the preclinical phase.

  • Development of biomarker assays
  • Indications and claims development
  • Product design considerations
  • Regulatory pathway identification (eg, FDA/LDT, product class)
  • POC vs. laboratory vs home use
  • CLIA/QMS compliance strategy
Read more about Companion Diagnostics Program Development