Technical project management of your lab’s analytical validation project

Testing laboratories are under constant pressure to stay compliant with standards while expanding the number of molecular tests offered. Validating a workflow is one of the most critical steps prior to launching a new test successfully. Yet, many labs inadequately plan and execute their analytical validation (AV) process. 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 business.

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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 350 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

Cut Costs—Help reduce costs and provide transparency of your end-to-end investment with up to 48% less financial impact than the average AV

Maintain Compliance—Receive proper documentation templates that facilitate your lab compliance


Reduce your assay validation 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 launching new molecular tests.

Analytical validation workflow completed 75% faster with AV consulting service

analytical-validation-workflow

The AV consulting services can reduce your overall investment by up to 48% because of the time savings the service provides. Labs that perform AV themselves 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:
Project management by an AV specialist
Dedicated on-site field applications specialist
Workflow training and optimization
Technical review
Optional: Confirmatory orthogonal testing support

What you receive:

Validation plan template
Protocol templates
Samples and controls
Data analysis consultation
Final report template
Optional: Orthogonal testing consultation

Unsure about the AV process?

Consider starting with a pre-validation evaluation. Our assay validation readiness (AVR) service helps save you time and costs by determining whether your workflow is ready to move on to a complete analytical validation.  

Guided by our global compliance services specialist (GCSS), the AVR service enables you to evaluate your workflow on a controlled scale, and helps you improve your chances for success before investing in a full scale assay workflow. The AVR service includes:

  • AVR control kit containing extracted DNA and workflow controls
  • Hands-on workflow training to demonstrate efficacy of the workflow
  • Final analysis report, evaluation consultation, and readiness checklist  

Learn more about AV consulting services for NGS assays

  

On-Demand webinar:
Demystifying Analytical Validation While Onboarding NGS Tests

 Watch now ›

Ordering information

Qualified solutions supported by our AV consulting services

Real-time PCR panels for infectious diseasePanel AV consulting services Cat. No.
Pharmacogenomics, OpenArray formatPanelAVQS12K
Pharmacogenomics, 384-well formatPanelA27145
Cystic Fibrosis, OpenArray formatPanelA28279
Vaginal Microbiota, OpenArray formatPanelA28966
Urinary Tract Microbiota, OpenArray formatPanelA34087
Respiratory, OpenArray formatPanelA40372
Antibiotic Resistance add-on, OpenArray formatPanelA42820
Toe Nail Fungus, OpenArray formatInquireA40371
Wound, OpenArray formatInquireA34091
Custom qPCR PanelInquireA34091
Additional AV consulting services for real-time PCR panels 
AV Consulting Services, custom panel A34091
Workflow training, genotyping panel A26745
Workflow training, microbial panel   A30162
Oncomine assays for oncology researchAssay AV consulting services Cat. No.
Ion Torrent Oncomine Myeloid Research AssayAssayA39199
Ion Torrent Oncomine Comprehensive AssayAssayA34088
Ion Torrent Oncomine Tumor Mutation Load AssayAssayA39199
Ion Torrent Oncomine Immune Response AssayAssayA39199
Ion Torrent Oncomine Focus Assay (OFA)AssayA34088
Ion Torrent Oncomine Childhood Cancer Research AssayAssayA39199
Ion Torrent Oncomine Inherited Cancer AssayInquireA39199
Custom Analytical Validation Consulting Services, custom assay A42904
Additional AV consulting services for Oncomine assays
Oncology consultation only, custom assay A39199
Oncology controls only A39558
Additional NGS instrument A41777
Confirmatory testing, NGS platform A39200
Confirmatory testing, Sanger sequencing platform A39201
Confirmatory testing, qPCR platform A39202
Confirmatory testing, regent kit (custom) A39203
Assay validation readiness service for NGS instruments A43330

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

Have an AV sales specialist contact me