Services

Services

“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

 

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AAALAC

LifeScience Alley

MassMEDIC

Support at Every Step

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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