Validation and Verification
Customized plans for validation or verification tailored for each client based on intended use, methodology, finances, and experience.
Quality and Regulatory
Guidance or development of regulatory systems, including Quality Management Systems, to meet applicable regulations in the United States, including CLIA, CAP, COLA, FDA, New York State Department of Health, and ISO 13485 and 27001.
Business and Marketing
Financial planning and scalability evaluations, competitive intelligence material generation, market research, and operational improvement services. Collaborative Services for billing, reimbursement, and market access are available through partnership network.
Who am I?
My specialty is breaking down the complex processes involved in Molecular Diagnostics and identifying a clear plan for companies to achoeve their goals. This can include designing validation studies that meet the requirements for NYSDOH, CAP, MolDx, or FDA, providing simple audit services to support laboratories dealing with regulations they are not familiar with, or even providing market research and competitive intelligence to assist with product development goals and planning.
I have a genuine desire to help
Patient Care affects all of us. Clinical Molecular Pathology requires a quality level that all of us can feel comfortable providing to our own families. I work with clients to ensure testing is sufficient for my own friends and family.
I was performing HER2 testing every day when my aunt was diagnosed with Stage 4 triple negative breast cancer. I remember what it was like, waiting for results, waiting to make a plan, worried about the answers, worried about the resources of the community in which she sought relief. It is our duty to do better.
Partnership.
My consulting services are not for a match for all companies. I can afford to be picky with my clients, and in return the clients on my roster get a level of service designed for the long term with reasonable pricing and honest timelines. For some items, including revenue cycle management, EHR/LIMS integration, or creating programs for logistics or purchasing departments, I have partnerships with experts in the field that I know and trust, and we can collaborate to produce a coordinated plan billed as one organization.
I also perform sub-contracting work with those partners, especially when they need to have an operational expert providing the scientific or regulatory guidance that matches their expertise. As an example, some partners might make recommendations as to the best CPT codes to use and how to submit dossiers to insurance companies and I will support the technical assessments and validation documentation needed to support their claims.
Projects and Planning
Next Generation Sequencing
PCR and ddPCR
Sanger and MLPA
Fluorescent In Situ Hybridization
Emerging Technologies
Why Choose Amber Leigh Consulting?
I have the expertise and knowledge to offer impartial advice and services at an honest price, and I will discuss the plans and objectives and tailor a proposal for your company ONLY if I truly believe I can enable your success.
The first hour long consultation is free. At times I find that clients do not actually need services. We listen to our client requirements and then select the right solution that fits. We care for your business as our own. We take a sincere interest in it and genuinely want to help your company reach its potential.
Have a Project in mind?
Completing large projects can feel like crossing the Grand Canyon alone. Sometimes you want a guide and a plan, sometimes you just want someone to verify your plan, and sometimes you need someone to walk you through every step before you go. Every client has different needs, but the goal is to get you where you need to be, with clear communication, and hopefully to teach you so that you can be more confident on your own in the future. If I am not sure I can guide you, I will let you know, and possibly connect you to others who would be more well suited to your needs.
