Early-Phase Clinical Development & Translational Medicine Services
End-to-end early clinical development, from first-in-human and proof-of-concept trials to regulatory submissions, biomarker translation, bioanalysis and clinical supply, delivered by one senior team with a single point of contact.
Receive your quote directly from the manufacturer.
Moving a drug candidate from the lab into people usually means coordinating several separate vendors: regulatory, clinical operations, bioanalysis, data analysis and drug supply. Each handover adds time and risk. Evotec brings these functions together in one integrated clinical development and translational medicine group. It connects directly to Evotec's preclinical, CMC and biomarker teams, so a program can move from discovery to proof of concept without changing partners.
Evotec supports first-in-human and early-phase studies in healthy volunteers and patients, with particular expertise in oncology. A clinical strategy group helps turn preclinical biomarkers into meaningful human endpoints. Partner clinical sites in Europe and the USA sit close to Evotec's facilities, and sponsors can also use any qualified site of their choice. In real projects, this close integration has cut Phase I timelines by around five to six months.
Evotec’s key capabilities include:
- Clinical strategy, study design and operational management
- First-in-human and early-phase clinical studies
- Translational medicine and biomarker strategy
- PK, PK/PD and population PK modeling
- Clinical data management and biostatistics
- Bioanalytical method development, validation and sample analysis
- Regulatory strategy, CTA/IND preparation and submissions
- Pediatric development planning
- Clinical supply manufacturing, packaging and logistics
- Integration with preclinical, pharmacometrics and other drug development functions
