Oracle Clinical is the standardized platform from Phase I through to Phase IV. The system is fully validated and satisfies the regulatory requirements of the FDA's 21 CFR Part 11 for electronic data and records through the implementation of appropriate procedures, documentation, audit trails and security.
We have the capability of direct connection into sponsors' clinical data management systems. This access ensures that processes and standards are followed, while the sponsor maintains control over data.
Data manipulation is performed using SAS from predefined extract views in Oracle Clinical. Richmond Pharmacology has the capability to produce specific Tables, Figures and Listings (TFLs), Statistical Analysis Plans and Reports using SAS reporting.
Our web-based solution for data capture in clinical trials. In addition to conventional paper CRF, we offer our clients the choice of using two alternative solutions — Remote Data Entry of paper CRFs on an ongoing basis during a study, and eCRF with real time data entry.
Both online systems offer prompt, remote and secure access to collected data, which is particularly useful on dose escalation studies with interim safety reviews. This ultimately ensures a faster database lock than using the traditional methods.