Mission
Conduct Research to Improve Patient Care


                              Clinical Development Services
Our Focus
 
  • Pulmonary Diseases
  • Infectious Diseases
  • Critical Care (Intensive Care)
  • Oncology
  • Immunological Disorders  

Our Services
 
Licensing and business development opportunity evaluation

     

  • Identification and evaluation of unmet medical need 
  • Science based program inflection point planning
  • Evaluation of clinical pharmacology, toxicology and clinical data
  • Assistance with fund raising 

Strategic and operational support for clinical development plans
 
  • Interface between diagnostic testing and clinical investigation
  • Transition from pre-clinical to clinical
  • Study Protocol Development
  • Study reports
  • Coordination with contract research organizations (research talent coordination)
  • Preparation of integrated summaries of safety and efficacy
  • Safety Assessment
  • Clinical Development Plans


 Regulatory Meeting Planning

  • Regulatory advisory meeting planning
  • Meetings with FDA/ CHMP
  • Briefing document preparation