\nLike many small teams, Moderna\u2019s regulatory organization
\nrelied on spreadsheets to track health authority (HA)
\nquestions and responses. When the pandemic hit, the number
\nand urgency of HA queries increased dramatically as Moderna
\nmoved swiftly to release a COVID-19 vaccine. To keep pace,
\ntheir regulatory team needed a more proactive, efficient way
\nto respond to HA requests.\n<\/p>\n
\nFortunately, a solution was close at hand. In less than five
\nweeks, Moderna was running a faster, more scalable HA
\nquery management process with ³Ô¹Ï±¬ÁÏ RIM.\n<\/p>\n
\nDespite receiving similar questions from multiple health authorities, Moderna\u2019s subject matter experts often
\nspent valuable time addressing them separately. They managed questions in a spreadsheet that was uncoupled
\nfrom the correspondence documentation, which made it difficult to navigate especially with so many global
\nusers. If Moderna\u2019s experts couldn\u2019t easily find a related answer in the tracking spreadsheet, they authored a
\nnew response\u2014raising the risk of delays and inconsistent replies.\n<\/p>\n
\nNow with ³Ô¹Ï±¬ÁÏ RIM, subject matter experts can easily determine whether a question has been asked before.
\nUnified data and documents enable them to quickly filter more than 1,600 queries and answers, along with the
\nfull text of each correspondence file, to find and reuse relevant responses. This increases response efficiency
\nand improves the consistency of information sent to global health authorities.\n<\/p>\n
\nModerna can also use the HA question object within Vault RIM to assign and track response progress, allowing
\ninternal and external experts to collaborate on responses and ensure their completeness and accuracy.\n<\/p>\n
\nWith ³Ô¹Ï±¬ÁÏ RIM, Moderna was able to scale up to handle an ever-growing volume of HA queries. Regulatory can
\nnow drive faster responses and quickly address hold-ups with real-time visibility into HA queries by country,
\nproduct, priority, and assignee. Queries can also be assigned to teams of subject matter experts with specific
\ndeadlines so they know which of their assigned questions to focus on first.\n<\/p>\n
\nSince the onset of the pandemic, Moderna\u2019s regulatory submissions have grown from 127 to 2,000+ a year\u2014a
\nmassive 15x increase. But with a streamlined HA query management process, they\u2019ll be able to keep approvals
\non track as they develop an exciting pipeline and continue to manage their global COVID-19 vaccine products.<\/p>\n","protected":false},"excerpt":{"rendered":"
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