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PPD® Laboratories Biomarker Lab


Our integrated approach to biomarker development is as unique as your project.

Capabilities Overview

PPD® Laboratories biomarker lab works closely with clients to shape their biomarker strategy and drive projects to completion even where uncertainty exists. Selecting the best analytical technology or method and the best regulatory strategy requires significant discussion and investigation. PPD Laboratories takes a collaborative cross-functional approach to each project in order to provide the flexibility needed to develop customized solutions.

Our lab works with clients to:

  • Identify the appropriate biomarker
  • Select the right regulatory approach from fit-for-purpose to full compliance
  • Choose the best analytical methodology
  • Develop and validate the specific assay(s)
  • Confirm intended useful purpose through clinical trials

To do this, the biomarker lab is equipped with state-of-the-art instrumentation and an unmatched depth and breadth of industry experience. The biomarker lab's capabilities include:

Explore our Biomarker Lab Capabilities

Integrated Approach

PPD Laboratories recognizes that biomarkers can be used throughout the entire drug discovery and development continuum. This means there are choices surrounding the biomarker data usage, regulatory compliance, technology and geography.

The biomarker lab is committed to helping clients identify the right strategy for each development phase so that they can efficiently achieve their end goals. To do this, PPD Laboratories has a dedicated biomarker lab and additional capacity integrated into our bioanalytical lab and our central lab. This integration:

  • Provides flexibility
  • Leverages the experience of PPD Laboratories across bioanalytical and central labs
  • Enables the biomarker lab to apply a tiered regulatory strategy from fit-for-purpose and GCLP to GLP and CLIA
  • Allows the biomarker team to provide a customized development strategy for each project

Our cross-laboratory model of support includes:

  • Working closely with clients to select the right development approach
  • PPD Labs Helping select the best technology platform to meet the unique requirements of each project
  • Developing and validating methods under the appropriate regulatory guidelines at each stage of drug development
  • Transferring and cross-validating assays to different/multiple locations or under multiple regulatory requirements, as needed
  • Providing insight into how to effectively integrate safety and efficacy biomarkers into clinical development
  • Global coverage for studies of all sizes

PPD Laboratories Biomarker Lab Locations

PPD Biomarker Lab Locations

 

Biomarker Labs Capabilities Molecular Genomics Virtual Tour Contact Labs

1Source: Industry Standard Research, 2016

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