Enterprise Biomarker Services

Enterprise Biomarker Services

Expertise, experience, and tools for an optimized biomarker strategy throughout your product’s development life cycle

Opportunities for optimizing clinical development strategies

The use of biomarkers in clinical development programs is a growing requirement for many disease areas. With this, there are new opportunities to integrate biological markers into your clinical development plan including:

  • Biomarker development - Identifying the right mechanism of action or specific disease indication
  • Biomarker assay testing - Choosing the right platform for developing a robust assay
  • Aligning development plans for successful co-development of drug and diagnostic

Identification of predictive biomarkers is essential for anti-cancer drug development. Q2 Solutions biomarker laboratory services help drug developers generate a biomarker identification strategy to help drive clinical and commercial success of a drug.

Biomarker expertise

Having helped develop some of the industry’s most well-known biological markers for personalized medicine including BCR-Abl, ALK, BRAF, C-KIT, EGFR, KRAS, HER2, MET, and PD-L1, we have the experience to incorporate these tools across the drug development process:

Early clinical development

Our scientific experts and biomarker lab staff can help you develop translational design strategies to identify, develop assays, and screen multiple biomarkers in parallel, so the most relevant ones can be identified sooner and get you to proof of concept as early as possible.

Clinical biomarker services and development

With clinical and scientific experts spanning multiple major disease states, we can use biomarkers to help optimize your clinical trials. Our global teams include assay development experts working in the largest system of CAP-accredited central laboratories. Employing comprehensive genomic, molecular and protein-based platforms we can rapidly and seamlessly develop, test, transfer, and integrate biological markers.

Pre-launch and commercialization

We work with IQVIA’s global experts in market access for drug/diagnostic combinations to develop robust product launch plans and commercial strategies.

Biomarker testing excellence

Our biomarker testing services and extensive capabilities and expertise to support identification and analysis including immunoassays, flow cytometry, genomic, liquid chromatography–mass spectrometry (LC/MS), as well as anatomic pathology and molecular pathology solutions.

Our world-renowned biomarker services scientific staff can help integrate biological markers across your development plan, from discovery, clinical development, and commercialization.

Download our brochure to view additional key disciplines and services to support your strategy.


Biomarker assay services for your success

Q2 Solutions has the breadth and depth of expertise, tools and capabilities to prepare and implement strategies to help drug developers effectively gain a competitive advantage – helping ensure your success in clinical trials, regulatory approvals and new product launches.
Q2 Solutions is your partner of choice for any program which requires biomarker identification, assay development, qualification and analysis to meet customer requirements.

Related Thought Leaders Insights

Translational Science and Innovation Laboratory (TSAIL)

Located in the heart of the Research Triangle Park, Q2 Solutions’ state-of-the-art Translational Science and Innovation Laboratory (TSAIL) is designed for exploratory biomarker research and new...

Bioanalytical Immunoassay Laboratory

Our new facility, in theworld-renowned Research Triangle Park, is the flagship laboratory for Q2 Solutions. This custom-designed, 160,000-square-foot facility houses a suite of scientific solutions...

Alzheimer’s Disease Clinical Trials

Alzheimer’s disease (AD) remains an area of severe unmet need and decades of research have yet to deliver validated diagnostics to evaluate disease progression. In 2021, only one marketed drug aimed...