Clinical Development & Translational Medicine

Our Clinical Development and Translational Medicine employs an end-to-end model to efficiently conduct and support clinical trials. The group is fully integrated within project teams.

Evotec Clinical Development and Translational Medicine seamlessly integrates with our end-to-end R&D offerings to provide a comprehensive range of solutions. These include integrated clinical-enabling drug development, regulatory strategy and dossier preparation/submission, full-scope clinical trial planning and execution, innovative translational biomarkers, ADME-Tox, and integrated CMC activities, as well as clinical supplies and logistics support.

• Extensive and diverse experience in designing and managing clinical trials, gained from both sponsor and CRO’s perspective
• Fully integrated solutions from discovery to proof-of-concept solutions including early phase clinical trials in healthy subjects and patients, as much as stand-alone services such as data management and statistics for all clinical development phases, dedicated PK, PK/PD and PopPK modeling, regulatory submissions, pediatric plans and more
• Seamless integration with our preclinical development platform and team
• Strategic and operational support for early clinical development, helping your team to develop the Target Product Profile, the full regulatory submissions and the entire clinical trials’ management
• Full support for Bioanalytical activities (method development, validation and sample analysis in GLP/GCP compliant facilities) and Pharmacometrics (data management, biostatistics and PK, PK/PD and PopPK modeling) under the same roof.
• Integrated Clinical Supply Manufacturing and Packaging support
• Strategic partnerships with established clinical sites in Europe (e.g. Italy - France), and in the USA with the flexibility to collaborate with any qualified site or network preferred by our partners at worldwide level

• An experienced Clinical Operations team that provides support for first-in-human studies in healthy subjects and patients (with a specific expertise in oncology trials) and early Phase trials
• A Clinical Strategy & Science team of experts that support the clinical development strategy and study design to facilitate the seamless translation of your project from preclinical to clinical, ensuring that preclinical biomarkers are translated to relevant endpoints in humans
• A highly advanced Pharmacometrics team equipped with cutting-edge technology to support Pharmacokinetics, Biostatistics, Data Management and modeling (PK/PD, Population PK, etc.)
• An integrated Regulatory Affairs team ensuring that your development strategy adheres to regulatory compliance and your CTA/IND submissions are “right first time”

Our Philosophy

At Evotec, we will manage your study as if it is our own study, you will have a fully dedicated team of senior level professionals, high degree of flexibility any unexpected occurrence might incur, all functions “under the same roof”, extremely rapid turn-around of data and information, thanks to the co-location of main study actors.

Deep & Extensive Experience

Our team is composed by highly experienced professionals with >20 years of experience in the clinical development and operations field, with a long track record of studies managed and executed as Sponsor as much as CRO.

Integrated End-to-End Model

Our clinical team is fully integrated with project teams through a single point of contact. This includes collaboration with our INDiGO teams, biologists within our translational biomarkers team, third-party providers, and our partners' teams. Additionally, our primary partner clinical sites, which support early phase clinical trials involving healthy subjects or oncology patients, are strategically located in close proximity to our facilities. This integration and geographical proximity have demonstrated real-life examples of reducing Phase I clinical trial timelines by approximately 5 to 6 months.