Clinical Trial Preparation

Opera provides support for study design and protocol development in the early preparation stages of a clinical trial program, as well as for CRF design and computerized databases in order to ensure the optimization of the data collection and organization process.

Key activities

  • Feasibility Assessment

  • Study Protocols

  • Patient Information Leaflet & Informed Consent

  • (e)CRF & Patient diary

  • Trial Master File (TMF)

  • Investigator Brochure

  • Laboratory Manual

  • Site Web Preparation