\n“I\u2019m a big advocate for \nThe company\u2019s three-person PV team brought safety in-house while maintaining \nWith ³Ô¹Ï±¬ÁÏ Safety, the company\u2019s PV team manages safety in-house and gives \nOnce their service provider has processed the cases, the PV team spends the \nSome sponsors may not realize that outsourcing safety activities will impact their \nTypically, most small PV teams rely on their vendors to access their safety data. \nOne of the ³Ô¹Ï±¬ÁÏ Safety features that the company values most is the ability to \nBefore implementing ³Ô¹Ï±¬ÁÏ Safety, the PV team would take the full 30 days allotted \n³Ô¹Ï±¬ÁÏ Safety helps the biopharma ensure that vendors \nThe PV team also tracks the difference in case dates. \u201cIt\u2019s a \nThe PV director recommends mock-audits \u2013 especially for first-time audits. Her team developed a checklist for audit readiness, including:<\/p>\n \nAbove all, having a single global repository to house the biopharma\u2019s data and information gives the PV director confidence during an audit. \u201cYou never want to leave an auditor hanging around waiting for a response or leave your team scrambling looking for documents,\u201d she explains.\n<\/p>\n \nNow that the PV team has created a strong foundation of operational oversight, they are scaling \n\u201cAs your company grows, \nFor emerging biopharmas, bringing a safety system in-house might feel daunting. There is \nAlthough PV professionals are typically risk-averse, the company\u2019s PV director recommends
\nowning your data. The lift
\nis not any different when
\nyou own your system.
\nYou\u2019re still paying the
\nsame amount of money
\nand it takes the same
\namount of work. But, if
\nyou\u2019re paying someone
\nelse to do it for you, you
\ndon\u2019t get visibility into it.\u201d
\n– Pharmacovigilance director at a dermatology biopharma<\/span>\n<\/p><\/blockquote>\n
\nfull control over its data and operational oversight. \u201cWith ³Ô¹Ï±¬ÁÏ Safety, I
\ndon\u2019t have to wait for someone to pull my data for me. I can see my data in real-
\ntime. I know how it\u2019s flowing and how long it takes to process a case,\u201d says the PV
\ndirector. \u201cIf an agency walks in and wants to see a report, I can run it for them right
\naway. Without that oversight, you can\u2019t give an inspector the timely answers they\u2019re
\nlooking for.\u201d\n<\/p>\nOutsourcing without sacrificing
\ndata oversight<\/h2>\n
\nvendors access to their system. Currently, they outsource case intake to a CRO.
\nThen, a service provider uploads case information or adverse events into Vault
\nSafety to process those cases.\n<\/p>\n
\nmajority of their time on data reconciliation and follow-up activities. This helps
\nensure their data is accurate and complete. \u201cWe review all the information from
\nour call center. We also check to make sure all the source documents are correct
\nbefore they go over to our processing vendor,\u201d says the PV director. \u201cFrom an audit
\nperspective, everyone needs to be on the same page at all times. For example, if
\nsomeone says they sent me five cases, I want to be sure that I got five cases and
\nboth parties signed off on them.\u201d\n<\/p>\n![\"\"](\"https:\/\/www.veeva.com\/wp-content\/uploads\/2024\/12\/Safety-Customer-Story-Image-1.png\")
<\/p>\nSafety data ownership for real-time visibility
\nand control<\/h2>\n
\ndata access, visibility, and ownership. \u201cMost PV teams think \u2018Of course we own our
\ndata. Our partner just stores it for us,\u2019\u201d says the PV director. \u201cBut, if you have to pay
\na fee to access or get it, then you don\u2019t own your data.\u201d\n<\/p>\n
\nWhen a company reaches out to its vendor with a request, it is up to the vendor
\nand the contract when they respond. Even for the most urgent requests, it can take
\nanywhere from several hours to multiple days to get the data and may come at a
\nfinancial cost.\n<\/p>\n
\nquickly run reports that are based on real-time data and stored in one place. The
\ncompany\u2019s PV director most frequently uses a report that reconciles serious
\nadverse event data from its clinical team on a monthly basis. The PV team has
\nalso created custom reports to track key metrics. For example, they have a report
\nthat tracks case volume and changed components to ensure their vendor is billing
\nthem correctly. They also have a report that checks the PADER for errors before
\nsubmitting it to the gateway. \u201cI pull this report at least once a week to make sure
\nthere are no errors in the coding. And, if there are, we know exactly what to send
\nback to our vendor,\u201d says the PV director.\n<\/p>\n
\nto them from data lock to submit their PADERs to the FDA. Since streamlining their
\nreconciliation reporting with Vault Safety and collaborating with Vault Submissions
\nPublishing, their reporting time is down to just 2 weeks \u2013 a 50% improvement. In
\nthe future, the company\u2019s goal is to further shorten its reporting time to 7-10 days
\nusing auto-submissions.\n<\/p>\nDefining KPIs and success
\nmetrics<\/h2>\n
\nprocess cases within their contractual agreed-upon timeline.
\n\u201cMeeting those time frames is important for oversight,\u201d says
\nthe company\u2019s PV director. \u201cYou don\u2019t ever want to be in a
\nposition where you miss a serious case and your vendor
\nis late to process it.\u201d She also appreciates having visibility
\ninto the company\u2019s safety data. \u201cIt\u2019s important to be able to
\nsee your data flowing in real time to know if there are any
\npotential safety signals.\u201d\n<\/p>\n
\nsimplistic metric, but it\u2019s important to make sure that you\u2019re
\non top of things,\u201d says the PV director. In ³Ô¹Ï±¬ÁÏ Safety, she
\nfilters through her workflows, then filters by date to find
\ncases that have been sitting in data entry or QC without
\nbeing processed. \u201cOnce we find those cases, we reach out
\nto our vendors to ask why they haven\u2019t been processed or if
\nthere\u2019s a problem with them.\u201d\n<\/p>\nTips for audit-readiness<\/h2>\n
\n
How to seamlessly scale globally<\/h2>\n
\ntheir safety processes globally. The company has partnered with a Japanese pharmaceutical
\ncompany to file for approval of their latest treatment with the PMDA. As the company prepares
\nfor its upcoming approval, the PV team is planning to use ³Ô¹Ï±¬ÁÏ Safety to communicate with
\ntheir Japanese counterparts while ensuring they meet both FDA and PMDA regulations. \u201cAs your
\ncompany grows, you have more countries and responsibilities. It\u2019s great to be able to scale your
\ndatabase quickly,\u201d says the company\u2019s PV director. \u201cComplex updates like these usually take a
\nyear or two. But, with ³Ô¹Ï±¬ÁÏ Safety, we can make them in a few months.\u201d\n<\/p>\n
\nyou have more countries
\nand responsibilities. It\u2019s
\ngreat to be able to scale
\nyour database quickly.
\nComplex updates like
\nthese usually take a year
\nor two. But, with Vault
\nSafety, we can make
\nthem in a few months.\u201d
\n– Pharmacovigilance director at a dermatology biopharma<\/span>\n<\/p><\/blockquote>\nEmbracing new safety technology<\/h3>\n
\na common misconception that sponsors who own their data will no longer have any vendor
\nsupport. In past roles, the PV director felt like she was left on her own after implementing a new
\nPV system. But, that has not been her experience with ³Ô¹Ï±¬ÁÏ Safety. \u201cWe have a strong support
\nteam with ³Ô¹Ï±¬ÁÏ Safety. Even after going live, we\u2019re still meeting with managed services regularly
\nand getting real-time responses to our questions,\u201d she says. \u201cIn all my years, I have not had this
\nkind of support from a vendor.\u201d\n<\/p>\n
\nbeing open to trying new tools. \u201cDon\u2019t be scared of technology. It doesn\u2019t hurt to see what
\nresources are available for you,\u201d she advises. \u201cEven if you\u2019re not ready right now, what if you\u2019re
\nready in a year or two?\u201d\n<\/p>\n