Oracle Clinical provides the life science industry with the most integrated Clinical Data Management (CDM) and Remote Data Capture (RDC) application on the market, while also providing best-of-breed CDM and RDC functionality. Unlike other vendor offerings, Oracle Clinical provides a single application architecture for both CDM and RDC. Oracle Clinical provides additional functionality in key areas such as integration, data collection, localization, and reporting.
More than 200 companies representing pharmaceutical, biotechnology, medical device, and contract research organizations have relied on Oracle Clinical to conduct more than 10,000 clinical trials, making it the market-leading clinical research solution. Oracle Clinical’s scalability, ease-of-implementation, ease-of-use, and built-in compliance increase your return on investment with every study you initiate.
Because Oracle understands every aspect of clinical data management in a changing market, Oracle Clinical can help organizations create solutions for their specific data management and business challenges. Its combination of broad coverage and deep functionality offers unmatched benefits in all aspects of clinical data management.
Study Design and Management
With Oracle Clinical’s study design and management subsystem, users can design protocols and amendments, as well as specify how patient data is tracked. The protocol design includes study objectives, investigator and site information, enrollment plans, drug treatment regimens, randomization schedules, and visit definitions. Oracle Clinical features sophisticated site, patient, and visit tracking to
- Assign and maintain information on investigators and sites
- Visualize the planned, projected, and actual patient enrollment and study timelines
- Develop detailed visit schedule specification and tracking, including the identification of missing and late Case Report Forms (CRFs)
- Manage and track treatment blind breaks
- Track patient availability and withdrawal information
Insert amendments transparently, within minutes, by adding values through quick picks and removing attributes by selecting a “do not collect” box. No recompiling or copying of objects is required.
Study Data Definition
Oracle Clinical’s study data definition subsystems enable a single study to be defined and conducted at several worldwide locations concurrently, with minimal additional effort. The essential subsystems include global library management, study data definitions, a data validation facility, and lab reference range management.
Study Conduct and Validation
Obtaining “clean” data is faster and simpler with Oracle Clinical. You can capture and edit data and edit the screen layout to parallel the CRF layout. Oracle Clinical’s unique data validation dramatically reduces the time spent identifying and finding data problems. This is accomplished through a library of procedures that can be used and reused continually. During this process, each data problem identified creates a discrepancy record that can be tracked and summarized. Data, validation checks, and discrepancies are all synchronized so that when a change is made to any unique component, the system automatically reflects the change in all areas. Oracle Clinical also supports the Data Clarification Form (DCF), which enables customized reports to be created and sent to an external source such as an investigator.
Data Access and Reporting
Oracle Clinical stores all data results in a universal format. For example, in the case of a company conducting 10 clinical trials and collecting 30 different modules/types of data per trial, Oracle Clinical makes it possible to manage a stable structure with predefined tables, rather than 300 separate tables (30 x 10). This universal format means that study setup, data collection, and data extract do not require specialist database design skills. Oracle Clinical also enables you to do the following:
- Automatically create views corresponding to each CRF and automatically extract data into SAS for analysis
- Create custom views combining data from multiple CRFs
- Create various data snapshots for interim analysis during normal data processing
- Query the data through an online query facility
- Include locked or frozen data, as well as discrepancy status information, in extracted data. You can execute more than 70 parameter-driven reports, immediately or in batch mode, to allow users to monitor and track information in a flexible, user-friendly environment. You can also preview the reports online before printing.