solutions which improve healthcare initiatives by providing information outreach, information analysis, decision support, business intelligence services, research information management services and infrastructure services. CTIS experience spans many diverse disease areas such as cancer, HIV/AIDS and other infectious diseases, heart, lung and blood diseases, diabetes, digestive and kidney diseases along with child health and human development. CTIS presence, both domestic and international, serves the needs of clinical centers, government and non-government organizations, academic medical institutions, contract research organizations and pharmaceutical companies. CTIS has received a number of notable achievements, awards and recognitions for their ground breaking informatics solutions providing an exceptional value.

Rays provides software development support to CTIS on the Cancer Therapy Evaluation Program-Enterprise System (CTEP-ESYS), a scalable, robust, web-based enterprise information system that provides unified access to multiple sources of data generated by CTEP-sponsored clinical trials worldwide, as well as extensive capabilities to index, track, audit, manage, select, sort, and locate the data. CTEP-ESYS provides essential knowledge and institutional memory in knowledge libraries and enhances information exchange and collaboration across CTEP and its global programs. It also reduces infrastructure and development costs; streamlines compliance with federal regulations and data standards; simplifies protocol management and abstraction; allows flexible access to centralized contact information; and supports mobile information access and dissemination. CTEP-ESYS comprises 22+ integrated applications, 150+ regular CTEP users, 1000+ integrated external systems, caBIG application compliance, and a technology stack ranging from Oracle 10g Database Server to Oracle 10g Application Server, Oracle 10g Forms/Reports, Oracle Web PLSQL, Java, and SOA. External users of the systems, such as cooperative groups and centers, are spread across the US, ensuring these users accessibility, availability, reliability, security, training, and support. CTEP-ESYS was built following RUP technology and CMMI Maturity Level 3 compliant processes.

The Clinical Site Monitoring System will support the need to ensure the rights and safety of volunteers, provide confirmation that the reported trial data is accurate, complete and verifiable from the source documents and that the trials are in compliance with Good Clinical Practices (GCP), applicable regulatory requirements and the currently approved DAIDS sponsored protocols. This system is being built using MS Visual Studio .NET 2005 with MS SQL Server 2005 as the database. The Clinical Site Monitoring System is currently deployed into the production environment and is being actively used by around 200 clinical research sites, around 30 DAIDS staff members, more than 100 clinical site monitors, managers and admin assistants as well as more than 20 Operations Centers and Data Management Center staff.

In partnership with CTIS, Rays designed and developed “eRIC”, a paperless, electronic system designed to auto-mate the submission, tracking and reviewing of scientific regulatory and compliance information that is required for the safe con-duct of human subject research. Firebird is a Investigator Registry developed to automate the existing FDA Form 1572 registration process to enable investigators to register online with NCI and other sponsors.