• Cutting Edge Biomed. Inc. is a pathologist run, pathology-centric and pathology-services-specific, contract research organization which includes a biorepository of standardized, vetted, quality assured, de-identified FFPE (formalin fixed paraffin embedded) tissues and tissue-associated data that has been validated for accuracy, authenticity and data integrity. All specimens have been processed in CAP and CLIA accredited laboratories in accordance with standard operating procedures. The biorepository comprises tissues from all organs, representing all pathologic diagnoses, as well as normal tissues, including large tumor reductive resection specimens, biopsies (endoscopic and core needle biopsies), FNAs and cytologic brushings and washings.
• In addition to our biorepository, we offer a wide range of consultation services including guidance and execution of:
a. IRB and grant applications
b. Study design
c. Appropriate specimen selection
d. Medical writing and editing of scientific papers for publication
e. Poster preparation for scientific meetings
and a wide array of histotechnology services including:
a. Tissue processing
b. tissue re-embedding
c. H&E slides
d. unstained slides
e. ancillary studies, including histochemical and immunostains
f. Histotechnology support services, including stained and unstained slides, tissue re-embedding and special stains including histochemical and immunocytochemical stains
Our medical director and CEO is a board-certified pathologist 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.
What differentiates us from the competition?
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
2. We collaborate with you upfront, and as needed every step along the way, to ensure you get what you need for best outcomes
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.
4. We understand that best results happen biospecimens 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 sufficient and appropriate for your specific study methodology.
6. We know that specimen selection is not a “one size fits all”.
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 or academia.
9. We prioritize customer service:
a. We respond to all outreach within 24 hrs
b. 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
c. Expedited service is offered when needed, to meet your deadlines. We understand research “unknowns” can lead to delays that weren’t accounted for, and we will do our part to help “recover” those lost days
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. 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.
3. To ensure biospecimen integrity defined by dependable data and standardized quality tissues,
enabling research outcomes to be honest, accurate, reliable, reproducible, and meaningful.
Mission Statement
1. 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
data.
2. To provide standardized, well-fixed, well preserved, tissues, processed in compliance with CAP
and/or CLIA protocols.
3. To ensure authenticity, accuracy, and reproducibility of biospecimen clinical and pathologic
data.
4. To maintain all ethical standards of patient confidentiality and patient rights according to the
Declaration of Helsinki, consistent with GCP (Good Clinical Practice).
5. 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”.
6. To maintain compliance with all regulatory standards and mandates for tissue and patient data
banking.
7. 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.
8. To be cost effective, efficient, and professional in all services provided.
9. To ensure timeliness of project completion.
10. 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.
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”.
2. Compliance with all regulatory standards and mandates for tissue and patient data banking
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
oversight.

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