Safe and Trusted
Cutting Edge Biomed. Inc. is a pathologist run, pathology-centric and pathology-services-specific, Contract Research Organization (CRO), which includes a biorepository of vetted, quality assured, de-identified FFPE (formalin fixed paraffin embedded) tissues and tissue-associated data that has been validated for accuracy, authenticity and integrity. We ensure our biospecimens are standardized, well-fixed, and well preserved, enabling research outcomes to be robust, accurate, reliable, reproducible, and meaningful. Specimen selection and quality assurance is pathologist driven to ensure cases best meet project goals and study inclusion criteria. A pathologist reviews every case to ensure accuracy of diagnosis and to ensure the biospecimen is of sufficient volume to allow completion of testing, specific to study methodology.
We are driven by a passion and commitment to help accelerate discovery and development that will bring new and improved diagnostic tests, prognostic indicators, risk assessment tools,
therapies, and devices to market sooner for improved patient outcomes.
In addition to our biorepository, we offer a wide range of histopathology, consultation and medical writing services, including support for IRB applications, guidance related to study design, and writing scientific papers.
We believe it is our obligation as healthcare providers to be involved as best we can in the support of medical research. In this way we care not only for our patients today, but for generations of patients to follow. We believe there is no greater or broader patient advocacy.
What Drives Us
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To provide the medical research community a reliable, dependable, consistent bio-specimen repository that provides access to the highest quality bio-specimens and strictest integrity of
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To provide standardized, well-fixed, well preserved, tissues, processed in compliance with CAPand/or CLIA protocols.
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To ensure authenticity, accuracy, and reproducibility of biospecimen clinical and pathologic
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To maintain all ethical standards of patient confidentiality and patient rights according to the Declaration of Helsinki, consistent with GCP (Good Clinical Practice).
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To meet 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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To maintain compliance with all regulatory standards and mandates for tissue and patient data
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To allow equal access to all reputable research institutions, including academia, biotechnology, biomedical, pharmaceutical, start-ups, and established commercial entities, be they for-profit, nonprofit, government funded or private organizations.
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To be cost effective, efficient, and professional in all services provided.
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To ensure timeliness of project completion.
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To supply alone or with an outside contractor, all processes, procedures, intellectual property/knowledge and knowhow, and all research materials to meet the specific needs of each research client/project.