Exemplary embodiments of the present invention provide three knowledge bases: (1) a clinical development plan (CDP) knowledge base for development of a molecular or cellular Phase I or II clinical trial; (2) a facility development plan (FDP) knowledge base for the economic and functional setup of translational laboratory, clean room production and cell handling facilities including the processes of planning, constructing and validating a facility for GCP testing and GMP manufacturing of products to support molecular and gene therapy clinical trials; and (3) a process development plan (PDP) knowledge base for development of manufacturing and analytic processes in support of Phase I or II clinical trials. The present invention also provides systems and methods associated with such knowledge bases.
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