Accelerating clinical development in Neurosciences
Strategic Clinical Development
Global Strategic Drug Development including CDP review and development support: Senior consultancy and expertise to enable maximizing efficiencies throughout the lifecycle of the clinical development plan
Strategic program and study planning
Regulatory dossiers and medical support for regulatory meetings: Medical review of critical regulatory documents, support with regulatory interactions and meetings
Medical Science
CMO services: Provide senior medical leadership and guidance across the company’s portfolio, while overseeing the overall stud(ies) and program conduct according to GCP-ICH and general ethical guidances
Clinical study Protocol review and development: consultancy on study design and protocol optimization
Medical advisory and safety surveillance services: Medical and scientific support throughout the clinical trial conduct, including safety reviews and safety board attendance
Clinical study report (CSR) and patient narratives review: Expert review of clinical trial data, CSR development and finalization
Operational Optimization
Clinical trial implementation and conduct strategies optimization
Assist with strategic feasibility of clinical trial globally, tailored to the specific clinical indication
CRO selection
Education
Training and education of clinical staff inclusive of medical and clinical operations team members
Internal and external educational support