Summary of Encore “One-Stop” Functions

  • Evaluation of study feasibility in the local region involving Encore physicians, clin-op managers, regulatory directors, and PIs.
  • Overall study project management, including development of an overall timeline and study budget based on regulatory, drug supply, enrollment, and clinical operations parameters.
  • Management of regulatory interactions at local/institutional levels to accelerate IND approvals and optimize timeline management.
  • Clinical operations management to seamlessly interact with Sponsor clinical study staff.
  • Language translations written and spoken, and training for study sites
  • Organization and conduct of investigator meetings.
  • Core Molecular/Pharmacogenomics Laboratories. These facilities will offer premium services involving the handling of tissue and serum specimens for analysis of targeted mechanisms and other critical companion/developmental studies.
  • Study Site Management
    • Pre-identification and qualification of study sites
    • Centralized contract negotiation
    • State-of-the-art electronic data capture (EDC)
    • Rigorous GCP and protocol training and certification