New 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:
- Identifying the right mechanism of action or specific disease indication
- Choosing the right platform for developing a robust assay
- Aligning development plans for successful co-development of drug and diagnostic
Solutions biomarker services help drug developers leverage biomarkers to help ensure clinical and commercial success of your product.
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 and HER2, we have the experience to incorporate these tools across the drug development process:
- Early clinical development – Our scientific experts 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 development – With clinical and scientific experts spanning nearly every major disease area, we can use biomarkers to help optimize your clinical trials. We can improve selection or exclusion of patients for therapy or dose adjustment, and increasingly, as a demonstration of efficacy or to detect toxicity. Our global teams include assay development experts working in the largest system of CAP-accredited central laboratories. Employing a comprehensive suite of genomic, molecular and protein-based platforms we can rapidly and seamlessly develop, test, transfer, and integrate biological markers.
- Pre-launch and commercialization – Working with Quintiles’ global experts in market access for drug/diagnostic combinations, we can develop robust product launch plans and commercial strategies to help ensure in-sync regulatory and payer submissions and launches, improving market adoption and availability to patients.
We offer an extensive set of capabilities and expertise to support identification and analysis including immunoassays, flow cytometry, genomic, liquid chromatography–mass spectrometry, as well as anatomic and molecular pathology solutions.
Our world-renowned biomarker services scientific staff can help you integrate biological markers across your development plan, from discovery, clinical development, and commercialization. We have the experience and technologies to deliver custom tissue or fluid biomarker assays specifically for your study.
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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 development program which requires identifying, designing and/or validating biomarkers, because we’re able to go a step further to help you understand how these biomarkers can help deliver actionable insights for better health™.