Preclinical Development

Preclinical program design, management and execution

Medelis has the capabilities to design and execute your preclinical program, using specialized oncology research models while handling technical writing, laboratory services, toxicology consulting and regulatory submissions.

We work with testing laboratories with the appropriate expertise to perform studies in compliance with Good Laboratory Practices (GLP). Since not all contract labs have the necessary skills, appropriate husbandry facilities or timely availability to accomplish specific studies, Medelis is able to select from several labs that we have prequalified for their expertise.

In this way we can offer our clients the most suitable resources to accomplish their tasks. A review of the specific types of preclinical studies available reflects the scope of our interests.

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

Medelis works with clients to develop precise animal-based, IACUC-approved protocols. We select the most suitable contract lab to perform the work, and the Medelis team oversees all work, protecting your interests and providing comprehensive, value-added oversight of study execution and interpretation of results.

Preclinical review and “gap analysis”

If you’ve already created your preclinical plan and would like an independent review, we can provide a “gap analysis” service that delivers an early evaluation of your current preclinical, manufacturing and clinical data, or plans for generating those data.

Medelis can serve as a check of proposed development tasks, resources and timelines, and help to identify developmental bottlenecks and risks.  We can also deliver a recommendation on mitigation of those risks, and provide general recommendations on regulatory strategies for global product registrations.

Request an estimate or contact us

If you are in a position to begin study development, or even 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.