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In Vitro Diagnostic (IVD) Development

Dedicated insights and know-how to advance your med tech 

Confirm analytical validity and support development of credible evidence for clinical validity of your IVD.

Partner with experienced global regulatory experts to advance the development of your IVD.

Access comprehensive clinical validation design and execution services.

Enable an integrated approach for your in vitro diagnostic.

From the outset, our focus is on supporting you in your journey to commercialize an IVD that is accurate, easily administered and readily available to the patients who need it—and these requirements inform decisions related to development strategies as well as study design and execution.

Our diagnostic development professionals work with you to to design an optimized development pathway to meet your go-to-market objectives. This plan translates into a seamless flow of activities required for both efficient and successful product launch. Because regulatory considerations are infused into the plan, the evidence gathered will provide the edge you need in your product’s target therapy area.

And, once your product is on the market, we're here to help you meet changing regulatory requirements and post-market study needs in a cost-effective manner.

Provide proof of analytical testing for your IVD

As your partner, we can design and oversee the delivery of analytical validation to the latest CLSI standards. Working with labs across the world, we’ll ensure your product meets the criteria needed to advance to clinical validation:

  • Precision: Repeatability validation, reproducibility
  • Trueness: Reference measurement procedure or comparator (qualitative, quantitative, semi-quantitative assays); inclusivity and recovery (as appropriate)
  • Linearity
  • Sensitivity (blank, detection and quantitation limit analysis)
  • Specificity (interfaces with exogenous and endogenous substances, cross-reactivity and mixed measurands for multiplex assays)
  • Traceability
  • Analytical, extended and hook effect measuring interval
  • Carryover effect and cross-contamination
  • Reference interval and expected values
  • Matrix equivalence (as required)
  • Stability testing (reagents, controls, calibrators and sample stability)
  • Flex (stress) studies for CUA waivers

Clinically validate your IVD

Simplify your outsourcing needs with a single partner that can oversee your program from beginning to end. Your project leader will oversee your project and keep you informed throughout the process—so you can focus on other areas that need your attention. 

Our clinical validation services include:

  • Feasibility studies
  • Clinical strategy development
  • Study design
  • Study operations
  • Safety monitoring and management
  • Data management
  • Biostatistical analyses
  • Clinical auditing
  • Medical writing

Get regulatory support where you need it.

Your IVD development program will be designed to comply with all regulations governing quality systems, such as the U.S. Food and Drug Administration’s Quality System Regulation, ISO 13485 and ISO 9001. We take a proactive approach to avoiding regulatory sanctions associated with costly delays and limited market access.

Strategy

  • Regulatory strategy planning
  • Claims and labeling
  • Portfolio management
  • Project management
  • Agency meeting support
  • Post-market clinical follow-up plan support
  • Design control support
  • Risk management support
  • Regulatory compliance consulting
  • Registration and licensing support

Writing

  • Clinical Evaluation Reports (CERs)
  • CE Support: Tech file/design dossier
  • Opinion letters
  • Strategy documents
  • Agency responses
  • Audit preparation and support
  • 483s and warning letters
  • Biological safety evaluation

Submissions

  • 510(k)
  • De novo
  • FDA electronic medical device reporting
  • PMA
  • IDE
  • Q-sub

Access a comprehensive patient safety solution and post-market support.

Marketed in vitro diagnostics can be indirectly responsible for unexpected or unwanted incidents affecting patient safety. When you need to feel confident and secure in your device review process, our safety data specialists are ready to assist, with highly standardized systems and artificial intelligence capabilities. Our thorough identification of root-cause challenges will ensure that incidents are reviewed and reported properly to keep your product in compliance.

Clinical Trial Safety
  • Site selection
  • Protocol design
  • Lab testing
  • Real-time adverse events monitoring
  • Benefit/risk profile monitoring
  • Regulatory submissions
Post-Marketing Safety
  • Global post-market vigilance
  • Medical contact center
  • Case processing
  • Medical review
  • Aggregate reporting
  • Safety surveillance
  • Label changes

Work with a partner committed to your IVD across its life cycle.

Once your product gains market approval, our team remains available to help you respond to evolving market conditions, sustaining the success of your in vitro diagnostic (IVD).

Every step of the way, our in-market support services are there to help maximize your idea. From training to compliance, preparation for audits and even managing recalls, we partner our expertise across therapeutic areas with your vision to give you every 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