الوصف

Web based system No special software, hardware, or plug-ins. Secure centralized database Clinical datasets import / Export (SAS, SPSS, CSV, Excel) Data warehousing Site status tracking Protocol reviews Change control tracking Subject or CRF tracking, entry, and verification Medical Coding & COTS Implementation (ICD, CPT, Medra, WHO-Drug, , WHOART) Serious Adverse Event (SAE) collection, processing, reconciliation and reporting Fully configurable access rights. Full electronic and automatic Audit Trail tracking. Full back-end clinical data management and programmed data validation checks. Personal digital certificates for authentication and digital signatures. Several options for secure transactions using secure SSL server with encryption. Electronic signatures fully compliant with HIPPA, GCP & FDA's *1 CFR Part *1. Customized Business Intelligence Reporting