\nAn emerging biotech company is revolutionizing biomedical research using its advanced CRISPR\/Cas9 gene editing technology. The company works closely with patients, families, healthcare professionals, regulatory agencies, and other groups dedicated to improving the lives of people with serious diseases.\n<\/p>\n
\nFor many emerging and midsize biotech companies, deciding whether or not to outsource safety operations \u2014 and which activities to bring in-house and when \u2014 is challenging. Not all companies have a fully staffed safety team, and outsource to contract research organizations (CROs) to manage their safety systems and perform pharmacovigilance (PV) activities. Without real-time data access, sponsor PV teams may need to wait for information from CROs or make decisions with limited data if there are short timelines.\n<\/p>\n
\nWith one approved drug on the market in three countries and several more in the pipeline, the biotech company aimed to gain real-time data visibility and control over its PV outputs by bringing in-house a modern safety application. Implementing ³Ô¹Ï±¬ÁÏ Safety<\/a> and ³Ô¹Ï±¬ÁÏ SafetyDocs<\/a> in 2022, the PV team has direct access to its safety data and greater control to improve data quality and safety outputs. The team can also make faster and more informed decisions with real-time visibility of all their data.\n<\/p>\n \nThe company\u2019s senior director for global pharmacovigilance and risk management explains what drew their team to the platform: \u201c³Ô¹Ï±¬ÁÏ Safety beats a lot of the competition by a long shot. It\u2019s intuitive and easy to use, and having first-hand access to our safety data is irreplaceable.\u201d\n<\/p>\n \n\u201cThe ongoing support around quality and real-time visibility also set ³Ô¹Ï±¬ÁÏ apart from the other safety databases,\u201d adds a senior manager.\n<\/p>\n \n\u201cWhen ³Ô¹Ï±¬ÁÏ showed us a system with the ability to create custom reports and dashboards to help address those decision-making processes, it was really attractive.\u201d \nSponsors that fully outsource their safety system and PV operations struggle with fragmented data and content across internal and external teams, impacting operational efficiency. The biotech company\u2019s senior medical director for global safety and risk management explains that fragmented data impacted safety processes: \u201cA lot of our information was disjointed. Our safety database wasn\u2019t in-house, our source documents were in different locations, and our vendor used different teams to handle processing and review.\u201d\n<\/p>\n \nOften, organizations wait until later stages of clinical trials to bring safety operations in-house, but the biotech decided to implement an in-house system relatively early. \u201cThe longer we wait, the more complicated and costly the migration is going to be, as you have more cases,\u201d explains the biotech\u2019s executive director and head of global pharmacovigilance risk management.\n<\/p>\n \nHigh staff turnover at CRO partners can make it challenging to efficiently maintain data quality and produce high quality safety outputs like listings and reports. \u201cWe would train people, but our studies are complex and the medical review is very challenging. We had to redo a lot of cases after they came to us for review,\u201d explains the executive director.\n<\/p>\n \nWithout direct data access, the biotech\u2019s safety team relied on the CRO to create reports and pull needed data such as the number of pending cases. \u201cRequesting a customized report would take so long that we just made do with what we had. Whereas with ³Ô¹Ï±¬ÁÏ, we can work directly with managed services to create the report that we need, quickly,\u201d says the company\u2019s senior manager.\n<\/p>\n \nData quality and output, in addition to real-time data visibility, were important drivers for bringing safety operations in-house. The biotech adopted a hybrid operating model and partnered with a CRO for specific outsourcing activities related to case management. With this hybrid model, the CRO works within the biotech\u2019s safety system, allowing them to maintain oversight and control quality while more efficiently utilizing internal and CRO resources.\n<\/p>\n \nWith the new in-house safety system and hybrid operating model, the PV team can manage the end-to-end safety process \u2014 catching and resolving errors earlier, rather than after processing.\n<\/p>\n \n\u201cRequesting a customized report would take so long that we just made do with what we had. Whereas with ³Ô¹Ï±¬ÁÏ, we can work directly with Managed Services to create the report that we need, quickly.\u201d \nTimely information is essential for PV teams to make crucial decisions. Often, the biotech\u2019s PV team would receive case information on day 10 of a 15-day timeline, shortening medical review times \u2014 particularly if a second review was needed. \u201cThis timeline meant we didn\u2019t have the information when we needed it,\u201d comments the senior medical director.\n<\/p>\n \nAn in-house safety system allows the team to make more informed and timely decisions, such as whether to continue a trial, increase risk mitigation strategies, or amend protocols. The company\u2019s senior director explains: \u201cWe now have the ability to understand and pick up signals before regulators do, so we can have that conversation and figure out the best way to move forward and minimize potential risks.\u201d\n<\/p>\n \n\u201cWe now have the ability to understand and pick up signals before regulators do, so we can have that conversation and figure out the best way to move forward and minimize potential risks.\u201d \nBy providing a single trusted source of safety information, ³Ô¹Ï±¬ÁÏ Safety can efficiently support PV processes across all studies. Instead of working in the CRO\u2019s safety database and the company\u2019s internal SharePoint, the biotech now has one safety system across all internal and external teams. The company\u2019s senior manager notes, \u201cYou can create templates, develop compliance oversight reports, and track everything in one place.\u201d\n<\/p>\n \nThe PV team is seeing significant efficiency gains with real-time access to safety information and shorter quality control (QC) workflows. Medical review is simplified as the PV team has access to all prior case versions, and fewer follow-ups expedite timelines. The executive director said, \u201cWe’re not relying on an outside vendor to generate those [reports]. It saves costs for us, because every time that you request something, there’s a cost associated with that.\u201d\n<\/p>\n \nThe biotech is further enhancing its processes with ³Ô¹Ï±¬ÁÏ Safety, including optimizing dashboards and reports, automating reporting rules, and exploring connections with other Vaults. ³Ô¹Ï±¬ÁÏ\u2019s three releases per year will enable the team to stay compliant with new regulations and leverage the latest innovations. The senior manager explains, \u201cWith other vendors, there\u2019s one major release where you\u2019re applying multiple configurations, which can be hard to test and implement. With ³Ô¹Ï±¬ÁÏ, you have configurations that are set in small doses.\u201d\n<\/p>\n
\n– Senior manager at emerging biotech company<\/span>\n<\/p><\/blockquote>\nMaking the move to an in-house safety solution<\/h2>\n
Improving data quality and controlling safety outputs<\/h2>\n
\n\u2013 Senior manager at emerging biotech company<\/span>\n<\/p><\/blockquote>\nInformed decisions, reduced risk<\/h2>\n
\n– Senior director of global pharmacovigilance and risk management at emerging biotech company<\/span>\n<\/p><\/blockquote>\nGaining efficiency with on-demand access<\/h2>\n
Connected systems and stakeholders<\/h3>\n