Challenge:

The National Institute of Allergy and Infectious Diseases (NIAID) requires a robust IT infrastructure to manage its extensive clinical research agenda, particularly in infectious diseases. The agency faces the challenge of coordinating multiple programs, complying with federal regulations, managing large volumes of regulatory documentation, and streamlining information exchange across its diverse research efforts. Additionally, the NIAID Division of AIDS (DAIDS) needed specialized support for clinical trial management, regulatory tracking, and compliance, while balancing operational efficiency and cost-effectiveness.

Solution:

CTIS, as a subcontractor to both Digital Infuzion and Technical Resources International, provided comprehensive IT and project management support to NIAID. CTIS’s contributions include maintaining NIAID’s Clinical Research Management System (CRMS) to facilitate seamless collaboration, data sharing, and regulatory compliance. By offering project management, program coordination, and federal records management, CTIS ensured that NIAID could efficiently manage the lifecycle of clinical trials and related regulatory activities. CTIS also developed and enhanced critical tools such as the Adverse Events Processing System and Protocol Registration, while supporting both legacy and modernized systems.
CTIS implemented a Digital Government strategy to harmonize data across NIAID’s internal and external collaborators, provided ongoing application security, and facilitated decision-making through business intelligence and analytics. Their approach encompassed software development, system maintenance, and compliance reporting, aligned with Agile and CMMI frameworks to ensure that security controls and operational efficiency were maintained at all times.

Impact:

CTIS’s partnership with NIAID advanced the organization’s ability to manage clinical trials, streamline regulatory documentation, and comply with federal regulations more effectively. The enhanced Clinical Research Management System improved data exchange, facilitated collaboration, and reduced infrastructure costs. NIAID’s Division of AIDS benefited from new, custom-developed systems that replaced outdated infrastructure, enabling faster and more accurate tracking of clinical trials, regulatory submissions, and adverse event reporting. CTIS’s strategic IT solutions helped NIAID advance its infectious disease research agenda, ultimately supporting public health initiatives at the national level.