About Us
How are we different?
1. We are entirely physician/pathologist driven so we understand the pre-clinical and pathologic considerations as they relate to down-stream clinical, real-world application.
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2. We collaborate with you upfront, and as needed every step along the way, to ensure you get what you need for the best outcomes.
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3. We listen when you tell us what it is you need, and we consult with you regarding the best specimens to achieve your study objectives.
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4. We understand that best results happen when biospecimen inclusion and exclusion criteria are appropriately defined, and adhered to, in specimen selection.
5. We Q/A not just the slides but the actual tissue blocks to ensure tissues selected are both “as advertised” and of sufficient volume to be appropriate for your specific study methodology.
6. We know that specimen selection is not a “one size fits all”. Your materials are customized to your study needs.
7. We have done pre-clinical research using FFPE biospecimens, so we know what it takes to do it right.
8. We are an equal opportunity provider. We grant equal access to all clients - small and large, for profit, nonprofit, pharma, biotech, and academia.
9. Our commitment to optimal specimen selection and data quality and congruence saves our clients both time and money.
10. We prioritize customer service:
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We respond to all outreach within 24 hrs
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We will meet all promised deadlines, no exceptions, even if that means our teams work around the clock to deliver your materials and data on time.
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Expedited service is offered when needed, to meet your deadlines. We understand research “unknowns” can lead to unanticipated delays and we will do our part to help you “recover” those lost days.
Leadership
Medical Director and Chief Scientific Advisor:
Sharon Mair, M.D.; FACP; FACCP.
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The CRO is led by Sharon Mair, a board-certified surgical and cytopathologist with over 30 years of pathology clinical practice experience, independent expertise and practice in research activities, and special expertise in legislation, regulations and standards of medical and human subject research and biorepository operations.
COO and CFO: Steven Tradonsky, M.D.
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Dr. Tradonsky is a board-certified Orthopedic surgeon who has been in the healthcare arena for 40 years. He has a special interest in healthcare-related business practices, research, and CRO strategic operations and finances.
Goals of Cutting Edge Biomed. Inc.
1. To increase researcher access to quality assured and standardized biospecimens with accurate data, to facilitate quality medical research and discovery, that will bring new and improved diagnostic tests, prognostic indicators, risk assessment tools, therapies, and devices to market sooner.
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2. To make such biospecimens available to all reputable researchers, without bias or restriction, be they large or small, well-established or “start-up”, for-profit or non-profit, private, public, academic or government organizations.
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3. To ensure biospecimen integrity defined by dependable data and standardized quality tissues, enabling research outcomes to be honest, accurate, reliable, reproducible, and meaningful.
Associations
Healthcare institutions and laboratories, both hospital-based and non-hospital based, representing biospecimen donors.
Protocols
Every sample is collected under approved protocols, ensuring that strict ethical guidelines are followed to protect patient confidentiality and safety. Each sample has the patient's consent or approved waiver of consent for use in a wide range of healthcare related research activities.
Compliance
1. Protection of all ethical standards of patient confidentiality and patient rights per the Declaration of Helsinki, consistent with GCP (Good Clinical Practice), the provisions of the Health Insurance Portability and accountability Act of 1966 (HIPAA), and the applicable regulatory requirement(s) according to The Code of Federal Regulations Title 45, Part 46 which covers the protection of human subjects in “research (which is) subject to regulation”.
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2. Compliance with all regulatory standards and mandates for tissue and patient data banking.
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3. The repository has IRB approval from WCG-IRB, including a waiver of consent for use of PHI covering all biospecimens in the repository. The IRB is updated to include all donor sites as new sites affiliate with the repository. This provides “blanket” protection to donor institutions and ensures every donor site’s specimens are treated with the oversights necessary to maintain compliance with biospecimen research.