Clinical Gateway bridges the gap between remote data entry and Oracle® Clinical, delivering integration of study definition, patient data and discrepancies between Oracle® Clinical and MACRO.
Clinical Gateway is available from InferMed for Oracle® Clinical users who wish to benefit from MACRO’s site friendly world-class EDC system.
MACRO is InferMed's modular, integrated electronic data collection system for clinical research. With intuitive and interactive tools for study definition, on-line and off-line remote data entry and remote study monitoring, study set-up time is reduced and time to database closure is improved.
Clinical Gateway will reduce study set-up time, enforce global standards and simplify data transfer.
Using Clinical Gateway
Clinical Gateway operates as a staged process:
1. Clinical Gateway Design Tool
Based on a study definition created in Oracle® Clinical, Clinical Gateway generates a Study Definition that can be used by MACRO. At the same time, it creates a 'Study Map' that will be used to translate clinical data coming from MACRO.
2. MACRO - Study Definition
Once the study definition has been transferred to MACRO, additional features such as attractive form layouts can easily be created.
3. MACRO - Electronic Data Collection
The same study definition is now ready for on-line or off-line data capture and remote monitoring using the state-of-the-art MACRO EDC system.
4. Clinical Gateway Server
Clinical Gateway transfers clinical data from MACRO into Oracle® Clinical according to the Study Map.
5. Clinical Gateway Admin Tool
Clinical Gateway is invisible to most users, who see only the user interface of MACRO or of Oracle® Clinical. But for those who need access to administrative and auditing functions, the Clinical Gateway 'Admin Tool' provides functions such as the status of any designated server, the mapping status of studies using the link, a log of all link activity, and even the remote configuration of the link itself.
6. Discrepancies
Discrepancies raised on Oracle® Clinical can be automatically transferred to MACRO for resolution by site staff. Changes to data and responses to discrepancies are sent back to Oracle® Clinical for final closure.