“C-HIT is pleased to announce we have been awarded a contract by the U.S. Food and Drug Administration (FDA) to provide operations and maintenance (O&M), integration services, and software development for the Safety Intake Processing Systems (SIPS) program. SIPS is comprised of three systems, MedWatch, Safety Reporting Portal (SRP), and Global Substance Registration System (GSRS) in which observed or suspected adverse events, problems, and complaints can be reported to the FDA. These systems provide health professionals, consumers, and patients the means to voluntarily report observed or suspected adverse events and problems for human and animal products to FDA.
On this contract, C-HIT will provide O&M support, along with modernization and enhancements of SIPS and the individual subsystems. These modernization and enhancement initiatives will include leveraging robotic process automation (RPA), artificial intelligence/machine learning (AI/ML), and data analytics to improve performance and the user experience. “C-HIT is humbled by FDA’s decision to award this contract to us for the third time. We are excited to continue our partnership with the FDA and deliver innovation to meet the SIPS program’s needs,” stated Dr. Srivasavi Chaganti, C-HIT President and CEO.”
Source: C-HIT
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