Clinical Development

 

Fully Integrated Development: Discovery through Clinical Proof of Concept

Evotec is a fully-integrated drug discovery and development partner, providing a comprehensive source of high quality scientific solutions with consultant-level expertise to our partners, which includes fully integrated research and development as well as clinical development through to Proof of Concept. 

Our Clinical Development team offers:
  • A core team with deep and broad experience across all phases of development and multiple therapeutic areas  
  • Seamless integration with our integrated development platform
  • Industry-leading timelines with significant reduction in clinical startup timelines, as well as the timeline through Phase I and II
  • Experience in global settings including Europe, North America, Australia, Asia, South America, Africa
  • Support and guidance for global clinical development, regulatory, and commercial strategy including target product profile & plan development
  • Strategic partnerships with established clinical sites in Italy, France, Germany, and North America - and the additional flexibility to work with any qualified site or site network our partners prefer
  • Support for both healthy volunteer and patient-recruited early phase trials
  • Partnerships to support data management, clinical safety, and pharmacovigilance
  • Seamless integration with pre-clinical scientific teams, improving the quality of regulatory submissions and decreasing the timeline to first dose

While our Clinical Development team is currently focused on Phase I and Phase II trials, Evotec is actively investing in and expanding our clinical development team to a level that will support pivotal studies for marketing authorization. 

Integrated platforms supporting all stages of drug development

 

Evotec Clinical Development solutions integrates seamlessly with Evotec’s other core offerings
  • Integrated clinical-enabling drug development
  • Regulatory strategy and dossier preparation/submission 
  • Full-scope clinical trial planning and execution
  • Innovative translational biomarkers, ADMET and integrated CMC activities
  • Clinical supplies and logistics support

The right trial at the right time can have a lasting impact on a drug’s life cycle. Please contact us to discuss how we work with our partners to provide a clinical development strategy that delivers all the way through to commercialisation.

Project team structure

The Evotec Clinical Development leadership team is unique in its approach to trial management and communication, based on our extensive experience and coupled with areas of unmet need  in the industry.

For instance, every trial for every partner, no matter how large or small, is supported by a Joint Oversight Committee to ensure quick issue identification, decision making and resolution.  In addition, we employ a “Quality by Design” approach to risk management from protocol development through completion of the clinical study report.  
We believe in transparency and collaboration with our partners, and chose key performance indicators that translate to meaningful representations of the highest quality deliverables. 

Focus on quality

Evotec is part of the Avoca Quality Consortium, which includes >180 members in biotech, pharma, niche clinical service providers and CRO organisations. Our participation in AQC enables us to leverage industry-wide best practices in risk management, quality, and inspection readiness in clinical trial execution. 

 

Why should you choose Evotec?

Deep and dynamic experience

Our growing team is comprised of seasoned clinical professionals with an average of 20 years’ experience within large pharmaceutical organisations, as well as global clinical CROs. As such, we have global experience executing all phases of clinical development in the US, EU, Asia and emerging markets.

Full-scope capabilities

Our team utilises and an end-to-end model to conduct and support clinical trials. Therefore, our approach begins with regulatory dossier preparation and submission, including regulatory and clinical strategy, protocol development, and seamlessly continues through the clinical phase with site management, risk-based monitoring strategies, medical monitoring, data management, biometrics, bioanalysis, pharmacovigilance, CSR development, eTMF, programme management and the management of any involved third party organisations.

Integration

Our clinical team is fully-integrated with project teams through a single point of contact, whether they be Evotec’s INDiGO teams, biologists within Evotec’s translational Biomarkers team, Evotec’s regulatory team, a 3rd party provider, or the teams of our partners. Our partner clinical sites that support early phase clinical volunteer trials are located in close proximity to our facilities to reduce logistical complexity with sites in the US, Toulouse, France and Verona, Italy. Based upon real life examples, this combination of integration and proximity (organisational and geographic) can reduce Phase I clinical trial timelines by between 5 and 6 months.

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