Bringing TMF in-house with a three-person team<\/h2>\n
\nBefore implementing ³Ô¹Ï±¬ÁÏ eTMF, Praxis outsourced TMF management to a large CRO. The company decided to bring its eTMF in-house<\/a> to increase oversight, access to documents, and simplicity.\n<\/p>\n \nNow, Praxis\u2019 TMF team of three manages their eTMF in-house and invites CROs to work in their system. Everyone on study teams, from data managers to regulatory affairs specialists, is responsible for uploading their documents into Vault eTMF. Then, the TMF team classifies them. Kelly values the reassurance that in-house document classification brings. \u201cI\u2019m able to look at any classification in any study in ³Ô¹Ï±¬ÁÏ eTMF and feel confident that we\u2019ve inputted the correct data,\u201d she says.\n<\/p>\n \n \nBefore automating document transfer, Praxis went through several manual end-of-study migrations with its CROs. \u201cEvery CRO had different systems, so we ended up having to do a document-by-document review to make sure that our information was right.\u201d\n<\/p>\n \nSince implementing ³Ô¹Ï±¬ÁÏ eTMF, Kelly has used TMF Transfer<\/a> to automatically transfer completed documents and data records between Praxis\u2019 and its CROs\u2019 eTMF systems to streamline the move in-house. This includes: <\/p>\n \n\u201cAfter we set up the initial connection, it was just ready to go,\u201d says Kelly. Now, Kelly\u2019s team typically does not need to review document listings or audit trails. \u201cEverything is automatically in the system in a matter of minutes,\u201d she says. \u201cTMF Transfer takes exponentially less time.\u201d\n<\/p>\n \nKelly\u2019s team cut their TMF migration preparation time from 25 days to four days, an 84% decrease. They also reduced the number of people needed for study closeout from three to one while shortening closeout timelines by an average of three months.\n<\/p>\n \n“Now that we use ³Ô¹Ï±¬ÁÏ TMF Transfer, my team no longer reviews document listings or audit trails. Everything is automatically in the system in a matter of minutes.” \n \nFor emerging biopharmas, asking a CRO to work in your eTMF<\/a> might feel daunting. But, it may be the best option to meet a company\u2019s needs as it matures. For Praxis, bringing TMF in-house allowed consolidation of all TMF documents in a single system.\n<\/p>\n \nWhen managing relationships with CROs, Kelly recommends getting involved from the very beginning and clearly outlining responsibilities. Praxis includes the expectation that CROs work in its system in each RFP process and decides on a study-by-study basis which tasks CROs will own. \u201cIf we were to start a new study tomorrow, I\u2019d be involved in everything from the RFP process to the kick-off meeting to make sure our CRO knows exactly what to do,\u201d she says.\n<\/p>\n \nFor companies embarking on an eTMF implementation, Kelly suggests having a robust plan for configuration before going live to avoid having to retrain employees. The plan should include milestones, classifications, and any other key eTMF features.\n<\/p>\n \nKelly also recommends choosing an eTMF system that fits your organization\u2019s broader technology landscape. For example, Praxis takes advantage of the ³Ô¹Ï±¬ÁÏ Connections between ³Ô¹Ï±¬ÁÏ RIM<\/a> and ³Ô¹Ï±¬ÁÏ QualityDocs<\/a>. ³Ô¹Ï±¬ÁÏ Connections<\/a> are ³Ô¹Ï±¬ÁÏ-delivered integrations that seamlessly transfer data and documents. \u201cIf we\u2019re authoring protocols in ³Ô¹Ï±¬ÁÏ RIM or study plans in ³Ô¹Ï±¬ÁÏ QualityDocs, I can easily crosslink them in ³Ô¹Ï±¬ÁÏ eTMF when they\u2019re approved,\u201d says Kelly.\n<\/p>\n \n“If we’re authoring protocols in ³Ô¹Ï±¬ÁÏ RIM or study plans in ³Ô¹Ï±¬ÁÏ QualityDocs, I can easily crosslink them in ³Ô¹Ï±¬ÁÏ eTMF when they’re approved.” \nNow that the Praxis team has optimized their baseline eTMF processes, they\u2019re looking to expand. This includes expected document lists (EDLs) that empower teams to identify documents and take action. They\u2019ll also identify which reports and dashboards are most meaningful for monitoring TMF health. \u201cOne of my priorities is to bring the larger study team together to figure out what metrics are important for us to measure, and how we can represent them in Vault eTMF reports and dashboards,\u201d says Kelly.\n<\/p>\n \nThe Praxis team is already looking ahead to continually strengthen audit- and inspection-readiness as they move toward their first new drug application. With eTMF in-house, Kelly is confident that Praxis is ready for any upcoming audits or inspections<\/a>. \u201cIt gives me confidence to know that we\u2019re in control of our eTMF,\u201d she says. \u201cWe can make the changes we want and we control how quickly they happen. It makes managing our TMF so much easier.\u201d\n<\/p>\n![\"\"](\"https:\/\/www.veeva.com\/wp-content\/uploads\/2024\/06\/Praxis-Graphic-for-Web_1880.png\")
\n<\/p>\nEliminating manual TMF migrations<\/h2>\n
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\n– Katie Kelly, Associate Director of Clinical Study Operations, Praxis Precision Medicines<\/span>\n<\/p><\/blockquote>\n\n<\/p>\nProviding CRO access to ³Ô¹Ï±¬ÁÏ eTMF<\/h2>\n
Lessons learned from eTMF implementation<\/h2>\n
\n– Katie Kelly, Associate Director of Clinical Study Operations, Praxis Precision Medicines<\/span>\n<\/p><\/blockquote>\nNext steps for Praxis<\/h2>\n