MOLECULAR TESTING (NEW!)

Interested in molecular testing? With the renewed interest in infectious diseases, you may be interested in starting a molecular lab or adding it to your existing offerings.

Doctors Long and McBrayer have a background in infectious diseases and working with FDA regulated clinical trials. Whether you want to test for seasonal flu or emerging pathogens, we can help.

Validation Protocol for Molecular Assays

LAB ORGANIZATION (NEW!) Do you need help organizing your laboratory? We can help! For a daily rate, we will come with all binders and necessary office supplies to organize your laboratory. Whether you are in production or just getting started, we can help.

CERTIFYING SCIENTIST

Do you need help analyzing your mass spectrometry data? We can help!

We offer certifying scientist services to analyze your validation or patient data. We offer flexible fee structures to accommodate your laboratory’s size, sample volume, and needs. Contact us for more information.

DATA ANALYSIS TRAINING Are you new to LCMS data analysis or has it been a while? Are you questioning your previous training and want to make sure you’re doing it right? We can help! We offer certifying scientist training where we will help fine tune standard operating procedures, define acceptance criteria, and help you learn how to troubleshoot your assay when there’s a problem. We can hold your hand the whole time or check your work and let you know what areas need improvement. We can also help you understand your results and review report interpretation so you are confident your clients get the right result on time every time. Short staffed or just don’t like data analysis? No problem! We can do it for you. We have solutions to fit all your needs.

QUALITY CONTROLS Do you have a complicated QC recipe or would you rather be focused on production than mixing quality control material? If that sounds like you, we can help. We mix custom quality control materials in the buffer or matrix of your choice, aliquoted the way you want it for ease of use in busy production laboratories.

SPLIT SAMPLE STUDIES

Do you have a robust test menu with unique analytes? We have two split sample studies per year that cover alternate proficiency testing. If you have something unique to you, we can send blinded samples and put a report together for you. No matter the test menu, we have you covered.

Split Sample Registration Form

Example of Split Sample Graphs

VALIDATION SUPPORT SERVICES

Do you have a laboratory developed test? Do you need help with your science or documentation? Are you confident in the science, but don’t want the headache of dealing with paperwork? We can help put your validation report together.

Validation Protocol for Molecular Assays

Validation Protocol for Mass Spectrometry Assays

Examples of Validation Reports and Graphs

AUDITS AND MOCK INSPECTIONS Do you have an inspection coming up or do you just want to check that you are inspection ready? We can come to your laboratory and do a thorough review of assays and documentation then provide a summary report of any finding. If there are any deficiencies, we can help you to correct them.

MAINTENANCE LOGS Policy and procedure manuals, quality control manuals, standard operating procedures… If documentation is not your strength, we can create for you comprehensive documentation featuring your company’s branding.

LABORATORY PERSONNEL We provide personnel to fill regulated positions whether you are high complexity, moderate complexity, or just need some help with your CLIA waived program. We provide Lab Directors, Technical Supervisors (High Complexity,) Technical Consultants (Moderate Complexity,) Clinical Consultants and Certifying Scientists.