ARIANNE provides total product development integrated strategic planning

Consistent and continuous integrated strategic planning is the hallmark for product development success from early strategic consulting to full study management. Proven expertise in global operations allows us to execute and deliver projects on time and within budget.

• Non-clinical strategic planning
• Non-clinical study design and oversight
• Selection, qualification and management of non-clinical contract research facilities for GLP and GMP studies
• Scientific writing including non-clinical study reports and integrated summaries for regulatory filings
• Clinical program strategic planning
• Clinical operations management services
• Clinical evaluation of product in-licensing opportunities
• Development and execution of regulatory strategies for medical devices companies including IVDs (in vitro diagnostics) and combination products
• Services and support ranging from trial design, pre-market submission and post-market compliance
• International regulatory knowledge specific to the intricacies of the medical device and IVD industries