Submit a Preclinial Study
Dr. Mike McGarry, VP of Preclinical Studies, and other Medelis staff work directly with sponsors to develop the appropriate preclinical data to streamline the application process to begin clinical trials. We are familiar with appropriate preclinical animal and tumor cell models, and the eventual regulatory requirements to successfully transition to phase I trials.
Available preclinical research projects, done in some cases under the guidance of Good Laboratory Practices (GLP):
- Feasibility Studies – exploratory, with several tumor lines
- Proof of Principle – definitive, demonstrative experiments
- Model development
- Novel devices for administration of agents
- Special cell lines – mouse, human, or spontaneous transgenic/mutant tumors
- Route of administration and site
- subcutaneous at defined sites
- in situ
- intravenous
- ascites
- Efficacy of therapy in a defined animal model
- Leukemias
- Solid tumors
- Mammary, bladder, lung, brain, renal, lymphoma, melanoma
- Other, as needed and specified
- Metastases
- Endpoints
- Survival
- Tumor dimensions
- Body weight
- Blood/serum samples
- Terminal organ histology
- Target organ metastases
Request an estimate or contact us
If you are in a position to begin study development, please complete and submit this questionnaire for preliminary consideration and estimates.
Preclinical Questionnaire - Editable Microsoft Word 2003-2007
Preclinical Questionnaire - PDF version (not editable)
(Documents open in a new window; please save to your desktop and then open.)
If your project is not refined enough to focus directly on protocol development, or your interest is in determining the feasibility of your product, contact us now. We will work with you to focus and define your objectives to obtain necessary preliminary data.