 Phases I through IV

    Planning, advising and writing of clinical protocols-  GCP, ICH
         • Study design
         • Comparator, Placebo, Open Label, etc.
         • Parallel, Crossover  

    Sites 
         • Identification and evaluation criteria
         • Site initiation
         • Site Aids

    Investigators’ Meeting logistics, design and presentations
         • Critical acclaim
               - Thorough
               - Accurate
               - Ingenious

    Study dynamics and tracking: Faster, more accurate
         • Electronic Data Capture 
         • Telerandomization 
         • Design of Case Report Forms, Informed Consent Documents, Support Documents and Aids

    Adverse Event and Serious Adverse Event evaluation and decisions