


“Everyone in attendance agreed that you provided an extremely valuable learning experience that will influence design modifications to our vascular closure device. We look forward to working with LyChron again.”
—Vice President of Research and Development, Co-Principal Investigator
“Thank you very much for a job well done. I appreciate your effort and collaboration in getting the final report out on time.”
—Senior Pre-clinical Research Associate
For more information, please write us at:
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Whether
your innovation is a medical device, gene or cell therapy, or pharmacological
agent, LyChron understands the importance of well-run studies in developing
and refining your product and demonstrating its safety for human and veterinary
clinical trials and ultimate market release. That's why we support you through
the entire product development cycle, from initial proof-of-concept and
feasibility studies, to GLP and safety studies, to physician and clinical
training in animal and human anatomical models.
Obtaining data from animal models is essential to ensuring the safety and success of life-improving and life-saving medical devices and therapies for humans. LyChron provides expertise in studies involving large animal (swine, sheep, goats, calves, and dogs) and small animal models. Our team of professionals offers years of experience developing and supporting pre-clinical studies for a broad range of novel devices and therapies across multiple disciplines.
Proof-of-Concept and Feasibility Studies
To gather valuable feedback on product performance and viability and
generate strong data to support future product development or venture
funding, our technical staff can perform early prototype evaluations or
help you refine and develop your preliminary testing plan. We can help
you select the appropriate model and refine your study design to maximize
your results.
Product Development Studies
LyChron can support all of your product development efforts in human
anatomical or proven in vivo models, from initial evaluations and biocompatibility
testing through Good Laboratory Practice (GLP) safety studies to support marketing applications and
clinical review board submissions. We can customize our support to meet
your project needs, including assistance with designing and directing
studies, refining and writing experiment protocols, and completing final
reports.
Physician and Clinical Training
LyChron can provide human anatomical and in vivo models to support bio-skills
training for physicians preparing for human clinical trials and initial
product use. Our human anatomical services include obtaining serologically
pre-screened tissue specimens from licensed vendors or those accredited by the American
Association of Tissue Banks, screening medical records for disease conditions
of interest, and preparing and processing specimens to client specifications,
all in a respectful and professional environment.
LyChron can host training courses with multiple concurrent stations and facilitate didactic training in our large conference facility able to accommodate up to 80 physician participants. To help your meetings and training sessions go smoothly, we can arrange catering services, make dining, hotel, and sightseeing recommendations, and assist with travel arrangements for out-of-town participants.
Model Development
To effectively evaluate the efficacy of products for use in humans or
animals, LyChron can help you develop and create well-characterized
and scientifically valid disease models. Our new 64-slice GE
Healthcare Discovery VCT imaging system enables you to combine Positron Emission
Tomography (PET) and Computerized Tomography (CT) technologies to characterize and validate
models accurately, quickly, and non-invasively.
Regulatory Compliance
Through public agency inspections and client audits, LyChron has earned
an international reputation for regulatory excellence. We have refined
our quality system and regulatory program over many years of conducting
GLP and non-GLP studies. If you seek public
funding, LyChron has a National Institutes of Health (NIH) Public Health
Service (PHS) Animal Welfare Assurance on file, and staff expertise in
writing and winning grants from the NIH and other public agencies.
Because regulatory compliance is a key focus, our Institutional Animal Care and Use Committee (IACUC), which comprises veterinarians, veterinary technicians, scientists, administrators, community members, and others, provides real-time, thorough review of research proposals. Our facilities, animal care program, and IACUC have all been inspected and accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC).
Clinical Products
LyChron is a reseller of commercially available clinical
products to support your research and development, verification, and validation
tests. We can supply you with catheters, guide wires, and other items on
request.
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