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운영절차

  • Operation of a One-stop Conveyor System and infrastructure-optimized services
  • Initiation of services
  • Our service starts with the clients request for consulting. The client will have a consultation with us regarding  the test results of the drug candidate, information on the drug and target, etc. Then, you will draft the Efficacy Evaluation Request form. Depending on our prior review results, an evaluation plan will be drafted, which will be followed by the conclusion of an agreement.
  • By-stage review for accurate and professional efficacy evaluation
  • The Review Committee consisted of the disease specialists confidentially reviews all preliminary data the client provides.
  • Prior Review Committee: Review the preliminary data before agreement, and determine whether to undertake services / priority evaluation / evaluation contents, etc. Intermediate Review Committee: Based on the initial evaluation results, confirm and determine whether to conduct evaluation / changes to evaluation contents / QA concerning evaluation techniques, etc. Final Review Committee: Interpret the efficacy evaluation results / review the results of the drug candidates for efficacy
  • Request for additional data and review Request for efficacy evaluation > Prior review > Agreement > Evaluation of efficacy > Notice on the final result Prior Review Committee Intermediate Review Committee Final Review Committee
  • Stages of Implementation Process Request for efficacy evaluation Draft an Efficacy Evaluation Request Sign confidentiality & disclosure agreement Prior review Form Prior Review Committee Conduct Prior Review (whether to evaluate / contents / evaluation schedule) and notify the result Conclusion of agreement Draft and approve the Evaluation Plan Fine-tune the Evaluation Plan and sign the consequent Agreement Transfer the new pharmaceutical substance Evaluation of efficacy Evaluate efficacy for target disease Evaluators draft result reports The Intermediate Review Committee conducts the work (determine whether to evaluate / confirm the intermediate results) The relevant disease specialists confirm the result report