BioMedical Strategy
CLINICAL AFFAIRS

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

       

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