Proof-of-Concept, Efficacy and PK/PD Studies

This service delivers tailored preclinical proof-of-concept, efficacy, and pharmacokinetic/pharmacodynamic studies across oncology, inflammation, and infectious disease models. It targets early-stage biotech and pharma SMEs seeking to de-risk pipelines. The goal is to demonstrate proof-of-concept, quantify exposure–response, and inform dose/regimen. The service activities include study design, fit-for-purpose model selection (syngeneic, xenograft, disease-specific), dosing and monitoring, sample collection, bioanalysis, statistical analysis, and interpretation. The expected outcomes of the service are validated datasets that support go/no-go decisions and planning for IND-enabling work. Studies are performed in-house by TCS scientists with dedicated project management to ensure quality, timelines, and clear deliverables. The duration of the service is typically aligned to compound modality and endpoints.