#ORACLE EDC INFORM SOFTWARE#
#ORACLE EDC INFORM TRIAL#

In addition, Oracle Health Sciences InForm GTM's scalable platform enables flexible, speedy study design and build, robust data management, and real-time data visibility, and provides user-driven reporting tools and advanced analysis capabilities.

#ORACLE EDC INFORM SOFTWARE#

Its intuitive user interface, multilanguage capabilities, and associated software modules deliver a robust solution to meet the needs of today's global EDC users.

#ORACLE EDC INFORM TRIAL#

Oracle Health Sciences InForm helps clinical research coordinators, trial monitors, clinical data managers, and project managers work more efficiently and with greater accuracy throughout the clinical development process.

Oracle Health Sciences InForm Global Trial Management (InForm GTM) is an electronic data capture (EDC) system used by pharmaceutical and medical device companies to collect data during medical studies. Pharmacovigilance staff can focus on effective safety information management, regardless of where in the world the case originated. Oracle Argus Safety Japan leverages Argus' single global database for regulatory compliance. It provides the most comprehensive global adverse events case data management and regulatory reporting in the pharmaceutical industry. By integrating serious adverse events from clinical trials, companies have the opportunity to manage efficacy earlier in the drug lifecycle and can potentially address public health concerns sooner. Oracle Argus Safety also supports a company's end-to-end pharmacovigilance program by providing a simple and efficient way to comply with international and domestic regulatory safety reporting requirements from clinical trials through post-marketing surveillance. Oracle Argus Safety supports electronic communication with trading partners and CROs, providing visibility into compliance across a company's global licensing partnerships. Oracle's proactive approach to monitoring global guidance enables consistent regulatory compliance. It also facilitates internal company safety surveillance by analyzing the overall safety profile of both investigational compounds and marketed products. Oracle Argus Safety is industry-proven as having been used for more than a decade at leading pharmaceutical, biotech, CRO (Clinical Research organization), and medical device manufacturers. Oracle Argus Safety is an advanced and comprehensive adverse events management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. If desired, the Argus Case #, whether the safety user accepted or rejected the E2B file, and the rejection reason can be sent back to InForm. Potentially related adverse events, labs, and concomitant medications are sent to safety based on time frames you configure. You can also define which data should trigger a follow-up to safety if the data is changed. You can define which data should be sent to safety using Central Designer Logical Schemas. This integration automates the sending of the information to Argus Safety so that the Safety users can start work on the case. For instance, if an event is recorded in the Electronic Data Capture (EDC) system, the clock starts ticking for these reporting deadlines. This automation increases productivity by reducing the amount of reconciliation needed between the two systems. Adverse Event: InForm and Argus Safety integration automates the process of clinical study sites reporting serious or clinically significant adverse events for a drug or a medical device from Oracle Health Sciences InForm to the Oracle Argus Safety system.

Oracle edc inform