Non-clinical support
DRIVE INNOVATION WITH DATA: Expert Non-Clinical Statistical Services for Drug Development
In the competitive world of drug development, making data-driven decisions is crucial to your success. At METRONOMIA, we offer comprehensive non-clinical statistical services designed to streamline preclinical and toxicology research and bring your drug candidates to market faster.
Non-clinical statistical services are integral in providing robust data, minimizing experimental biases, and supporting data-driven decision-making in early drug development. At METRONOMIA, non-clinical and clinical statistical experts collaborate closely and deliver added value to your programs. Key advantages are:
- Diverse expertise: Non-clinical statisticians bring advanced techniques, while clinical statisticians ensure relevance to medical applications, enhancing overall analysis quality.
- Broader problem-solving: Combining different statistical perspectives leads to better solutions and data.
- Cross-disciplinary learning: Collaboration promotes knowledge exchange, helping both groups develop new approaches.
Non-clinical statistical services
- Consultation on appropriate statistical designs & analysis
- Statistical input to CMC experiments
- Implementing Design of Experiments (DoE) strategies
- Stability data analysis
- Biomarker analysis
- Statistical evaluation of in vivo and in vitro data
- Determination of anti-drug antibody (ADA) cut-points
- Evaluating toxicology studies
- Dose response designs and analysis
- Justification of dose (JoD) selection for first in human trials
- Sample size calculations and simulations
- Data visualization
- Data standards, e.g. processing data in SEND format
- Full compliance with regulatory guidelines of FDA and EMA
- Supporting interaction with regulatory authorities
Non-clinical medical writing
- Generating custom reports for your product dossier
- Generating summary results in presentations, tables and graphs
- Organizing and transforming your data in eCTD format
“Sourcing from over 30 years of experience, METRONOMIA has a proven track-record in supporting pharmaceutical and biotech companies in all aspects of their non-clinical and pre-clinical development. Our experts are fluent in non-clinical statistics and related medical writing, combining such extensive expertise with expert knowledge in pharmacology and pre-clinical development including regulatory safety and toxicity studies. Take a look at our non-clinical services, our team is stand-by with great anticipation to support you!”