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.

Have an AV specialist contact me


Our analytical validation consulting services provide technical project management of your lab’s AV, potentially reducing your overall time to launch by 75%.

With over 400 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 up to 75% faster than the average AV, 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 with up to 50% less financial impact than the average AV.
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.

Analytical validation workflow completed up to 75% faster with AV consulting service

The AV consulting services can reduce your overall investment by up to 50% 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


Ordering information

AV consulting services for qPCR

Cat. No.
AV consulting service for pre-designed OpenArray and Taqman array cards A41781
AV consulting service for pre-designed 384-well plate A41300
AV consulting service for pre-designed 96-well plate A43331
AV consulting service for custom qPCR-based panel or assay* A34091
AV consulting service for additional qPCR instrument A41778
AV consulting service for qPCR-based bridging study A34089
Additional AV consulting services for real-time PCR panels 
2-hour remote clinical qPCR training TRN00407
1-day clinical qPCR training TRN00406
1-day clinical OpenArray plates training TRN56211
3-day pharmacogenomics or cystic fibrosis workflow training A26745
3-day pathogen detection training TRN00302
2-day TAC or TAP pathogen detection training TRN00401
2-day qPCR TAC pathogen detection training TRN56216
3-day AV respiratory and pathogen training A51986
3-day AV urinary tract microbiota and pathogen training A51985
3-day AV pharmacogenomics 120 array and pharmacogenomics training A51987
Advanced QuantStudio OpenArray training 4476591
* Custom panels and non-Applied Biosystems workflow component can limit our capability to deliver custom training.
AV consulting services for NGS
AV consulting service for Oncomine assays or oncology research assays or panels A34088
AV consulting service for Oncomine assays or oncology research assays or panels, consulting only, no controls/samples A39199
Add-on AV service for next-generation sequencing (NGS)–based confirmatory sequencing (US only) A39200
Add-on AV service for Sanger sequencing–based confirmatory sequencing (US only) A39201
Add-on AV service for qPCR–based confirmatory workflow (US only) A39202
Add-on AV service for confirmatory sequencing reagent kit (custom request) A39203
AV consulting service for Oncomine assays or oncology research assays or panels, controls only A39558
Add-on AV consulting service for including a second or multiple instruments into NGS workflow A41777
AV consulting service for customer-designed Oncomine assays or oncology research assays or panels A42904
AV consulting service for validation readiness support on NGS instruments A43330
AV consulting service for Ion ReproSeq kit research application A47476
AV consulting service for CarrierSeq kit research application A47477
AV consulting service for SARS-CoV-2 surveillance assays on NGS instruments A48399
AV consulting service for analytical performance verification (APV) on NGS instruments A48557
AV consulting service for customer-designed regional guidance support on NGS instruments A48558
AV consulting service for myeloid research application on NGS instruments A48559
Add-on AV service for added samples to purchased NGS AV service A48560
Add-on AV service for inclusion of synthetic controls to purchase of NGS AV service A48561
AV consulting service for bridging studies on NGS instruments A48575
AV consulting service for confirmatory analysis workflow of NGS AV service A48615
AV consulting service for myeloid research application with bridging study support on NGS instruments (US only) A48980
AV consulting service for myeloid research application with bridging study support on NGS instruments (outside US) A48981
AV consulting service for regional guidance support on NGS instruments A49256
AV consulting service for germline panels on NGS instruments A50650
Add-on of analytical orthogonal testing consultation to purchase of NGS AV service (up to 20 samples) A51247

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

Have an AV specialist contact me


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