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Companion Diagnostics

Pharmaceuticals and diagnostics are undergoing rapid integration in the era of personalized medicine. We help you simplify and align co-development strategies to speed development and increase the probability of regulatory and commercial success.

The market landscape is changing – enhanced understanding of disease biology, the introduction of new clinical trial protocols, next-generation sequencing, reimbursement constraints, immunotherapy treatments and changing regulatory guidelines are all impacting the progress of companion diagnostics. Conflicting demands on the system make it difficult to assess the best way to move forward.  

You need an experienced partner with a deep understanding of clinical development, diagnostic development, regulatory requirements and strategic partnership models to help you achieve better outcomes. 

Optimize co-development outcomes

Q2 Solutions provides you with an optimal path to co-develop your companion diagnostic (CDx) with clinical development of the therapeutic, regulatory submission and market launch.  Our integrated approach is designed so you optimize time to market and commercial success.  
 

Tailored Solutions and Informed Insights:
  • Insights informed from our development expertise with > 100 companion diagnostic development engagements
  • Regulatory experts who can advise optimal regulatory strategy for your CDx: laboratory developed test (LDT) or in vitro diagnostic (IVD)
  • Scientific experts who can inform diagnostic test platform and format selection and validation across a breadth of therapeutic areas
  • Informed insights from Quintiles' 14 Therapeutic Centers of Excellence and 1,000 PhDs, >1,100 Medical Doctors and >850 biostatisticians/statistical programmers with extensive drug development experience
Delivery excellence:
  • Global footprint and quality systems to ensure assay development and validation across a wide spectrum of patient populations for your targeted therapeutic and companion diagnostic
  • Strategic partnerships with a variety of diagnostic manufacturers allows us to fully integrate all your development partners under one governance structure for a seamless, tandem development approach
Better outcomes:
  • We chart out the optimal regulatory and market access pathway so you can recognize peak market adoption and long-term commercial success
  • Q2 Solutions helped develop diagnostics for many of the biomarkers used today, including CTLA4, PD-1/PD-L1, BCR-ABl, ALK, BRAF, C-KIT, EGFR, KRAS and HER2

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End-to-end integration

With Q2 Solutions’ comprehensive development solution, we can take your therapeutic in tandem with the companion diagnostic to market faster. Our integrated solution can manage all stages of development for your companion diagnostic: 
Strategy development:
  • Informatics expertise from our extensive tissue repository and next-generation sequencing capabilities to help you refine your target patient population and enable rare disease studies
  • Clinical Trial planning and design
  • Regulatory strategy
  • Consulting experts to advise on IVD strategy and biostatisticians to provide guidance for adaptive trial design
Drug-diagnostic execution:
  • Biomarker discovery and development
    • Inclusive of tissue, fluid, cell and genomic-based biomarker development expertise
  • Assay development from feasibility to validation
  • Sample analysis expertise
    • We have Board certified pathologists on staff to establish scoring methodology, and act as principle investigators for your study
  • Clinical trial execution expertise
  • Partnerships with IVD manufactures to ensure tandem development with your therapeutic
Commercialization:
  • Market access, reimbursement and commercialization strategy consultants to help optimize your companion diagnostic go-to-market strategy

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