The Information Security and Technology Division (ISTI) at the DCC provides secure IT services and sophisticated infrastructure, services, and applications to help researchers be more engaged in cross-institutional translational research activities
ISTI is composed of three teams:
• Information Management Services
• Clinical Trial Management Services
• Infrastructure Development and Support
Together, these teams develop, enhance, and support multiple, clinical research IT applications and tools such as, Oracle Clinical, Siebel Clinical, Argus Safety , REDCap, I2B2, Project Tracking, Eagle-I, and Profiles.
ISTI offers a full range of information technology, data collection, and analytic capabilities delivered in an integrated manner. ISTI staff has over 80 years of experience which includes software developers, database and programmer analysts, system administrators, technical architects, and computer security experts. ISTI provides programming support to all projects, including designing, implementing, and supporting applications for clinical data collection and analysis. ISTI also provides custom application development, server co-location, dedicated server and virtual server hosting and system administration. DCC features a robust IT infrastructure, including private high-speed WAN, secure remote access systems, secure Internet, and data centers equipped with high-performance servers and large capacity storage units.
Services We Offer:
Through our application development and systems integration services, you can gain consulting and delivery expertise in both end-to-end systems integration and custom application development.
At ISTI, we help define your requirements, write specifications and design, develop, test and integrate software across multiple platforms — including Internet technologies — enabling your systems to function in new operating environments.
Our custom application development services include:
- Application design, development, and implementation
- Systems integration/consolidation
- Re-engineering, performance tuning and porting services
IT Infrastructure Services
Our consulting, managed services and integrated solutions create agile, flexible IT environments.
Our IT infrastructure services include:
- Co-location: Whether you need a server or mirror of critical production systems or a row of cabinets, we can accommodate your needs. We also offer colocation all the way down to the rack unit.
- Managed Co=location: combines our expert system management services with your hardware. Let us handle the management of the infrastructure so your people can spend more time on higher value tasks for your research.
- Virtual Servers: ISTI provides maximum computing resource flexibility while eliminating the capital expenses and hassles of owning servers. Virtual Servers deliver an enterprise computing and storage infrastructure solutions.
- Physical Servers: Need a Dedicated Physical Server? No problem! We can even help architect and design an end to end solution to meet your unique requirements.
- Consulting: Not sure what you need? Our staff is ready to learn about your research and help assess your needs. Our staff have tackled many highly complex challenges and developed reliable and extensible solutions
- System Administration : We offer system administration services including OS maintenance and troubleshooting services.
Clinical Data Programming Services:
We provide end-to-end solutions that cater to clinical research and data management needs. Our team of functional and technical professional’s aid through the entire lifecycle - from CRF design to regulatory submissions, including data management related activities. We ensure utmost compliance with regulatory requirements, standard operating procedures, protocols, and other processes and practices.
Our services include:
- Case Report Form (CRF) design and creation
- Custom database development and data specifications
- Database implementation on web-based application
- Data extraction for statistical analysis
- End user support
DCC have the following applications to support clinical research and data management:
- Applications for Clinical Data Management (CDMS): Oracle Clinical and REDCap
- Applications for Electronic Data Capture (EDC): Oracle Clinical-Remote Data Capture (RDC)
- Applications for Safety Data Management: Oracle Argus
- Seibel Clinical Trial Management System (CTMS): Maintenance of site and personnel information, generation of CRA visit reports, and issues management
Provide the necessary tools to find and link experts working in distributed RCMI research centers with others across the network. Expand collaboration between researchers and investigators across RCMI CC ’s institutional boundaries and increase the potential of multi-disciplinary and cross-institutional translational research activities.
EAGLE-I / PLUMAGE
Develop simplified resource discovery networking interfaces that are based on the Eagle-i resource discovery platform to expedite the process of finding specialized services, instruments, software and other core facilities that are provided and operated by the other RCMI institutions.
Oracle Clinical System (OC)
OC is a secure, web-based, clinical research software system that provides an integrated Clinical Data Management (CDM) and Remote Data Capture (RDC) solution that includes functionality in key areas such as integration, data collection, localization, and reporting. It offers an easy-to-use, intuitive user interface accessible via any web browser. It is the first validated clinical research system at the DCC which is maintained as a 21 CFR Part 11 compliant system. Oracle Clinical is recommended for clinical trials that may utilize federal contracts, industry sponsors, or will be submitted to the FDA.
Oracle Siebel Clinical Trial Management System (CTMS)
CTMS Siebel, a secure, web-based clinical trial management software platform to maintain a centralized trial management database for all investigators. CTMS enables users to design and conduct trials having multiple arms and epochs, parallel arms and repeating cycles. CTMS also facilitates communications to the study team.
Oracle Argus Safety
Argus is a secure, web-based application provides a platform of end-to-end pharmacovigilance solutions designed to ensure regulatory compliance.
REDCap is a secure, web-based application designed to support electronic data capture for clinical research studies. REDCap provides:
1. An intuitive interface for data entry (with data validation)
2. Audit trails for tracking data manipulation and export procedures
3. Automated export procedures for seamless data downloads to common statistical packages (SPSS, SAS, Stata, R)
4. Sets forth procedures for importing data from external sources
5. Establishes advanced features, such as branching logic and calculated fields within electronic forms.
REDCap was initially developed and deployed at Vanderbilt University, and now has collaborative support from a wide consortium of domestic and international partners.
REDCap was selected by the RCMI CC to offer a user-friendly, cost-effective alternative for researchers as well as provide a secure application to promote HIPAA compliance
Find ways to enhance research engagement with communities through planning, designing, and implementation of custom built solutions that address researchers need for sophisticated community resources and tools to help ensure their success.
PROJECT TRACKING APPLICATION
Help RCMI CC ’s network leadership manage projects’ logistics using custom built applications. Design and build summarization/detailed reports to measure progress and outcome.
I2b2 and ETL tools
Create procedures, methods, and libraries to help researchers share, extract, and transform clinical and biomedical datasets by using automated and intelligent ETL processes.
Build clinical and biomedical repositories for inter-discipline produced datasets. Overcoming the complexity of ETL process design will yield faster development cycles, less dependency on technical expertise, and encourage more collaboration.