Biotech's Trusted Partner From Start To Finish

Our team of subject matter experts can support your clinical development planning in the areas of regulatory, medical/safety, data analytics, and clinical operations. We can also define elements of the Target Product Profile (TPP) including the indication, population, study design and dosing schedule for first-in-human clinical trials based on: 

• Pre-clinical data, literature and discussions with Key Experts/Opinion Leaders
• Pre-clinical and regulatory gap analysis
• Synopsis and protocol design
• Discussing strategy and study design with Regulatory authorities (e.g., scientific advice meetings, protocol advice, pre-IND, IND-filing, etc.)
• CTA submission