End-to-end solution for your lab's analytical validation project

Research laboratories are under constant pressure to stay compliant with standards while ensuring the success of their research. Verifying the performance of a workflow is one of the most critical steps prior to implementing a new test. Yet, many labs inadequately plan and execute their analytical validation (AV) process. An inefficient AV can potentially turn a 10-week validation into a 40-week or more process, resulting in substantial delays to the lab’s ability to process valuable samples and significantly impacting the lab's research and therefore business.

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“The documentation alone is worth the AV service—and every lab should use it.”
–Dr. Prerana Jha
Karkinos Healthcare

Discover Real-World Success: Analytical Validation Customer Case Study

See the benefits of our Analytical Validation Consulting Services

With over 1,000 successful AV engagements to date, our experienced AV project managers and global compliance service specialists help ensure successful AV outcomes.

Save Time—get personalized consultation to help accelerate your launch, enabling research laboratories to get into testing faster and accelerate the return on investment.
Cut Costs—help reduce costs and provide transparency of your end-to-end investment.
Maintain Compliance—Receive proper documentation templates that facilitate your lab compliance. Our experienced consulting team will assist in designing a proper sample run strategy to help you establish test performance metrics.

Enabling you to reduce your assay verification timeline and overall investment

See an overview of the steps of the AV process and how our AV consulting services can help reduce your timeline for verifying the performance of your research assay.

Support faster launches with AV consulting service

The AV consulting services can reduce your overall investment because of the time savings the service provides. Labs that perform AV themselves could pay more in materials and labor, potentially incurring months of loss in revenue opportunity due to delays in sample processing.

As part of the engagement, our team provides key services throughout the process including: What you receive: 
Project management by an AV specialist Validation plan template 
Dedicated on-site field applications specialist Protocol templates 
Workflow training and optimization* Samples and controls 
Technical review Data analysis consultation 
Optional: Confirmatory orthogonal testing support Final report template 
  Optional: Orthogonal testing consultation 

* for qPCR workflows, a workflow training is required (sold separately).


Unsure about the AV process?

Consider starting with a pre-validation evaluation. Our analytical performance verification (APV) solution service helps save you time and costs by assisting you in determining whether your research solution is ready to move on to a complete analytical validation.

Guided by our global compliance services specialist (GCSS), the APV service enables you to evaluate your research solution on a controlled scale, and helps you improve your chances for success.

APV control kit

  • Final analysis report
  • Evaluation consultation
  • Readiness checklist
     

Regional service

Our Analytical Validation consulting service is flexible and adapts to regional validation requirements.

The Analytical Validation Regional (AVR) service is designed to follow regional requirements globally. The AVR is guided by a global compliance service specialist (GCSS). This takes you through an analytical validation process tailored to fit your global region. The AVR service includes:

  • Project management by an AV specialist
  • Samples and controls
  • Data analysis consultation
  • Template documentation
hwood

“The experience we had with the Thermo Fisher AV is truly unmatched! The AV services were very comprehensive to include the AV plan, controls, expertise, data analysis, validation summary templates, and standard operating procedure templates. The service and professionalism of the staff made the experience all the better. After all the time we spent working with this group I feel I can call them friends. I would without a doubt recommend Thermo Fisher’s analytical validation services!”

 

Heather Wood

Technical Laboratory Director
Catalyst Diagnostics

Still have questions about analytical validation? Have a specialist contact you.

Have an AV specialist contact me

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Consulting service options

For Research Use Only. Not for use in diagnostic procedures.

Consulting services offered for the guidance in enabling the analytical validation in support of research efforts only.