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pre-clinical studies

Designing and performing the appropriate preclinical studies are crucial to progress the product from development stage to clinical application stage. Time and resources are valuable asset during development stage, which should to be used effectively and efficiently. Performing appropriate pre-clinical studies in compliance with the regulatory requirements will save both time and resources, and augment the approval prospect for clinical trials. Each product is different in its own way and regulation applied are based on the type of product and its mode of action.

​Understanding and performing the essential preclinical research and development studies will enable product for clinical assessment and product license application. STS Pre-clinical solutions offer consultation in experimental design and will explore the product pharmacology, pharmacokinetic, bio-distribution, tumorigenicity and toxicity profiles to be studied with an aim to support the intended clinical trial design for first-in-human testing.

Few of the services that STS Pre-clinical Solutions expert team of professional offer include

  • Develop and implement preclinical discovery/development plans from concept to market.
  • Accelerate timelines using customized preclinical and CMC plans.
  • Implement those plans using proprietary project management tools.
  • Conduct Gap Analysis for drug discovery/development programs.
  • Manage budget and budget projections for R&D.
  • Estimate final product requirement and resources for planned studies.
  • Conduct detailed analysis of preclinical studies – study design, reviewing data and study reports.
  • Identifies and predicts potential preclinical issues.
  • Can recommend qualified CROs and CMOs to outsource studies and provide project management services that include generating requests for proposals, negotiating contracts, implementing studies, monitoring studies, reviewing data and preparing reports.
    • Monitor compliance of studies with government regulations such as GLP, animal welfare, etc.
    • Protocol and study design development and review
    • Review and critical appraisal of technical and scientific reports and standard operating procedures
    • Due diligence support
  • Provides guidance on next steps and development needs to the next milestone.