pre-clinical studies
Designing and conducting appropriate preclinical studies is essential for advancing products or technologies from the development stage to clinical trials. Time and resources are valuable assets during this phase, and using them effectively is crucial. Performing compliant preclinical studies not only saves time and resources but also enhances the likelihood of regulatory approval for clinical trials. Since each product and technology is unique, regulations vary based on product type and mode of action; a one-size-fits-all approach does not apply.
Understanding and executing essential preclinical research and development (R&D) studies enables products to move toward clinical assessment and licensing applications. SOMA’s Preclinical Solutions offer expert consultation in experimental design, exploring pharmacology, pharmacokinetics, biodistribution, tumorigenicity, and toxicity profiles, along with ADME studies to support clinical trial designs for first-in-human testing.
SOMA Preclinical Solutions Services:
- Develop and implement preclinical discovery and development plans from concept to market.
- Accelerate timelines using customized preclinical and CMC plans.
- Utilize proprietary project management tools for effective plan implementation.
- Conduct gap analysis for drug discovery and development programs.
- Manage budgets and projections for R&D activities.
- Estimate final product requirements and resources for planned studies.
- Conduct detailed analyses of preclinical studies, including study design, data review, and report generation.
- Identify and predict potential preclinical issues.
- Recommend qualified CROs and CMOs for outsourcing studies, providing project management services that include generating requests for proposals, negotiating contracts, monitoring studies, and preparing reports.
- Ensure compliance with government regulations, such as GLP and animal welfare standards.
- Develop and review protocols and study designs.
- Perform critical appraisal of technical and scientific reports, as well as standard operating procedures.
- Provide due diligence support.
- Offer guidance on next steps and development needs to achieve the next milestone.
