Expertise in clinical drug development and clinical pharmacology
Strategic clinical drug development
CURARE experts are dedicated to find the optimal development path for each compound within the budget and time-constraints given. Each development program is unique and needs special CURE and CARE. Our innovative clinical drug development plans and study designs enable informed and step-wise decision making. In the translational drug development and early clinical phase CURARE accelerates achievement of clinical Proof-of-Concept, whilst improving your probability of success. Furthermore, CURARE has experts specialised in pediatric drug development.
CURARE designs clinical pharmacology programs separating nice-to-haves from need-to-haves. Key activities, done at the right time, mitigate the risks within the development program. A well-thought interpretation of the results justifies selection of the optimal dose regimen and supports the label text at marketing authorization. Results from toxicokinetic and pharmacokinetic analyses from validated software can be used to substantiate the path forward.
Clinical regulatory support
Relationships to regulatory authorities are key to a successful development program. The experts of CURARE have a track record of successful interactions with regulatory authorities in Europe, US and Japan in various development stages.
Hands-on clinical support
CURARE experts can take the lead in the execution of complex clinical programs. Where necessary, we select and oversee the outsourcing of different aspects of the program to service providers or academic partners.