KCRI has significant experience in the study development and setup thanks to continuous cooperation with local and international experts, as well as collaboration with other CROs (for whom KCRI often serves as a local or regional agent).
- Study design, including statistical requirements (see Data Management and Biostatistics for details)
- Protocol development
- Case Report Form design (e-CRF, paper CRF)
- Development of other study documents
- Site selection (recommendations and matching based on study profile and volume requirements are available. For additional information, see Network)
- Study registration and approval by regulatory bodies (see Regulatory Affairs for details)
- Site initiation