Tailored strategies to support accelerated time to market
- development and utilization of a well defined target label
- state of the art designs and robust criteria for milestone decisions to ensure cost-effectiveness
- active management to secure data integrity and data integration from different sources to allow the most rapid production of clinical summaries for marketing applications
- management of CRO selection and provision of oversight
Key Deliverables
Our multi-disciplinary team of senior consultants
- generates and reviews clinical development plans
- integrates risk minimization measures into pivotal studies
- advises on clinical and operational performance indicators
- develops competitive service specifications and budget models
- provides medical monitoring and safety management
- contributes to data monitoring committees and strategy advisory boards
- supports marketing authorization applications and interactions with regulatory agencies
in the pre-, peri- and post-approval phases