Diagnostics
The know-how to advance your diagnostic development
Optimize your diagnostic and IVD development with our insightful expertise. Our integrated approach ensures analytical validity, clinical credibility and streamlined global regulatory compliance.
Optimize your development pathway
Confirm analytical validity and develop credible evidence for the clinical validity of your IVD.
Global regulatory expertise
Partner with experienced global regulatory experts to advance your diagnostic development.
Accelerate market readiness
Fast-track your diagnostic development with our comprehensive medical, scientific and regulatory expertise.
An integrated approach for your diagnostics
We work with you to commercialize a diagnostic that’s accurate, easily administered and readily available to patients. Our diagnostic professionals design a pathway that meets your go-to-market objectives, ensuring a seamless flow of activities for a successful launch. Regulatory considerations are part of the plan, giving you the edge you need in your target therapy area. Once your product is on the market, we help you meet regulatory requirements and post-market study needs efficiently.
Simplify your outsourcing needs with a single partner, from start to finish.
Together, exceptional diagnostics are possible.
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Clinical validation services
- Feasibility studies
- Clinical strategy development (e.g., test methods)
- Study design
- Study operations
- Safety monitoring and management
- Data management
- Biostatistical analyses
- Clinical auditing
- Medical writing
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Expert regulatory support
Ensure your diagnostic or in vitro diagnostic (IVD) development program complies with all quality systems regulations, including the FDA’s Quality System Regulation, ISO 13485 and ISO 9001. Our proactive approach keeps you clear of sanctions, costly delays and limited market access
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Comprehensive patient safety and post-market support
Maintain confidence and security in your device review process. Our safety data specialists use highly standardized systems and AI capabilities, ensuring identification and reporting of root-cause challenges to keep your product compliant.
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Full life cycle support
Once your product gains market approval, our team helps you navigate evolving market conditions, sustaining the success of your diagnostic. From training to compliance, audit preparation and recall management, we use our expertise across therapeutic areas to give you every conceivable market advantage.
Our commercial services include:
- New labeling claims and expanded folio
- Recall support
- Obsolescence planning and preparation
- Training program design and implementation
- Remediation programs
- System compliance
- Strategy reimbursement assessments
- Payer initiative and reimbursement strategies
- Payer insights and payer mix analysis
- Pricing