– Pradnya Gunjotikar, PV Manager, CG Oncology<\/span>\n<\/p><\/blockquote>\nEfficiently collaborating within one safety system<\/h2>\n
\nCG Oncology and Catalyst Safety can easily and efficiently collaborate and provide transparency to both parties using a cloud-based safety solution. CG Oncology can refresh Catalyst Safety\u2019s custom reports anytime with ³Ô¹Ï±¬ÁÏ Safety, saving significant overhead to get the latest safety data or case status.\n<\/p>\n
\nBoth the sponsor and CRO can track operational metrics, such as case handling time and the number of initial cases and follow-ups received on a weekly, monthly, or per-study basis. Data visualizations provide an operational overview and are useful for stakeholder communication. \u201cThe real-time dashboards and reports are intuitive,\u201d said Gunjotikar. \u201cI can easily present the high-level data to leadership and the review board, or drill into the data for more information.\u201d Gunjotikar also uses the SAE reconciliation and query management reports daily to improve data quality.\n<\/p>\n
\nThe Catalyst Safety team uses the reports to effectively manage workload. \u201dWe use the case list every day to track case volume, progress, and prioritize cases such as suspected unexpected serious adverse reactions (SUSARS),\u201d said Lisa Dawson, senior director of safety, Catalyst Safety.\n<\/p>\n
Simplifying safety with a unified solution and automation<\/h2>\n
\nManaging adverse event intake to case processing and regulatory submissions within ³Ô¹Ï±¬ÁÏ Safety simplifies the user experience. It is easier to train users and improve productivity. Eliminating manual handoffs also reduces the risk of errors and provides greater control and end-to-end visibility.\n<\/p>\n
\nAdditionally, CG Oncology uses submission and distribution rules to automatically submit individual case study reports (ICSRs) to health authorities, including submissions to the FDA, as well as auto-distribute safety reports to partners. The submission and distribution reports in ³Ô¹Ï±¬ÁÏ Safety enable CG Oncology to easily confirm that all partners have been notified of safety events in a timely manner.\n<\/p>\n
Continuing to improve safety and outsourcing processes<\/h2>\n
\nThe partnership with Catalyst Safety gives CG Oncology visibility to monitor KPIs and prepare for upcoming deadlines with minimal effort. As Phase 3 of one study concludes, with plans to file for a biological license application (BLA), the flexibility of ³Ô¹Ï±¬ÁÏ Safety allows CG Oncology to support safety through clinical trials and commercialization.<\/p>\n","protected":false},"excerpt":{"rendered":"
CG Oncology and Catalyst collaborate in ³Ô¹Ï±¬ÁÏ Safety to achieve efficiency and gain real-time oversight of safety data.<\/p>\n","protected":false},"featured_media":82212,"parent":0,"template":"","product-link-list":[],"class_list":["post-87216","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/87216"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/customer-stories"}],"version-history":[{"count":0,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/87216\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/82212"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=87216"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=87216"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}