Life Sciences

Oracle Health Sciences InForm GTM

The Oracle Health Sciences GTM platform and its supporting modules provide clinical sites and trial sponsors with all the tools required to efficiently conduct and manage EDC-based clinical trials.

With its intuitive user interface, multi-language capabilities, and associated software modules, the Oracle Health Sciences InForm GTM platform delivers a robust solution to meet the needs of today’s global EDC user. Its flexible and scalable architecture and user-friendly design accommodate the needs of smaller organizations looking for solutions today that will expand to meet their needs tomorrow.

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BENEFITS

Provides comprehensive data entry, edit-checking and query management functionality for data capture and data cleaning
Utilizes the same feature set for users around the globe, minimizing training and support costs
Offers the flexibility to run a multi-language study with the advantages of a single underlying database architecture
Delivers robust reporting and analysis capabilities for real-time visibility and access to trial data
Enables sponsors to make more InFormed decisions through earlier and more insightful views into trial data, mitigating risks and improving overall trial conduct
Allows systems such as IVRS, CTMS, Imaging, and ePRO to easily integrate with the InForm environment through the support of Web Services and industry standards

SUPPORTING AND OPTIONAL MODULES

Oracle Health Sciences Central Designer—Streamlines the study build process by reducing setup and validation time, allowing study teams to work in parallel and enabling companies to apply industry standards
Oracle Health Sciences Central Coding—Facilitates multi-study, industry-standard, and customized coding of drug names, indications, and adverse events
InForm Portal—Provides a communication vehicle for site and sponsor InFormation exchange and document management with version control capabilities
Auto Site Assessment (ASA)—A Web-based service offering for assessing a site’s hardware compatibility for participation in an InForm trial
User Management Tool (UMT)—a Web-based service offering for provisioning sites and users within an InForm trial
Oracle Health Sciences IRT on Demand—Provides randomization and trial supply management via interactive response technology
Oracle Health Sciences InForm CRF Submit—Generates electronic common technical document (eCTD) compliant PDF editions of the InForm electronic case report forms (eCRFs) for site and sponsor archive and eSubmission to regulatory agencies
InForm Adapter—Provides a number of Web services-based interfaces that enable integration, extensibility, and workflow across the InForm modules and with other third-party software systems
InForm Reporting and Analysis—Leverages a built-in reporting model that enables a sponsor’s staff to run both standard and ad-hoc operational and clinical reports
Oracle Health Sciences WebSDM on Demand—A data validation and review tool for tabulation data submitted in CDISC SDTM standard format used to pre-validate submissions and CRO data, providing a submissions data mart with FDA-compatible review tools