A sound clinical phase is of fundamental importance to both the company’s R&D, as well as proof of safety and efficacy for the regulatory authorities.  Providing the necessary guidance in maintaining these goals is key when designing a clinical study and creates a valuable position for the Company.

• Strategy Development  
• Design of study/ies
• Preparation of Clinical Investigation Package 
  • Study Protocol  
  • Case Report Forms [CRFs]  
  • Investigator Brochure  
  • Informed Consent & other administrative material  
  • Site & Investigator agreements  
  • Clinical Standard Operating Procedures [SOPs]  
• Submissions to Ethical Committees & Regulatory Authorities
• Management of Clinical Study
  • Project Management  
  • Selection of Investigators & Sites
  • Pre-Site Activities  
  • Site Initiation & Closure  
  • Periodic Monitoring and reporting   
  • Intermediate and final study reports