FDA Selects C-HIT for Safety Intake Processing Program Modernization
C-HIT is pleased to announce that the Food and Drug Administration (FDA) has selected us as the preferred industry partner for modernizing the Agency’s Safety Intake Processing (SIP) program. Comprised of three systems – MedWatch, Safety Reporting Portal (SRP), and Global Substance Registration System (GSRS) – SIP is used by health professionals, consumers, and patients to voluntarily report observed or suspected adverse events and problems pertaining to human and animal products to the FDA.

C-HIT’s project work will encompass support services required for continuing the enhancement, development, implementation, user support, training, and ongoing maintenance for the three component systems of the SIP program. C-HIT will also be responsible for identifying and analyzing consolidation, integration, and interface opportunities among the three systems and developing enhancements using industry standard Agile/Scrum/Kanban methodologies. Teaming partners for C-HIT include Chickasaw Strategic Pointe, LLC, an 8(a), HUBZone, and Indian Small Business Economic Enterprise and International Software Systems, Inc., a small, minority-owned business.

“We are honored that FDA placed their trust in us for ensuring the readiness, access, reliability, availability, and usability of their SIP systems and subsystems for current and new users,” stated Dr. Srivasavi Chaganti, C-HIT President and CEO. “We are committed to helping FDA achieve its program maintenance and modernization objectives and will leverage our mature Agile development and CMMI Level 5 expertise to deliver service quality through repeatable, managed processes.”