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<\/p>\n\nFor many growing biotechs, it can be difficult to choose a clinical trial operating model that works for the organization\u2019s size, budget, and case volume. Some biotechs see in-house trial management as their end goal. Others may outsource most or all their trial activities to a CRO. But, with a modern, cloud-based clinical trial management system (CTMS), companies can maintain operational oversight regardless of their model.\n<\/p>\n
\nDealing with fragmented and manual processes led John McAdory, Vice President of Clinical Operations at CG Oncology, and his lean team of 11 employees to implement a new in-house CTMS. \u201cWhen I first started at CG Oncology, we were building our studies from scratch each time. We had a CTMS, but relied mostly on our CRO to collect information like action items, deviations, and monitoring reports without relying on spreadsheets,\u201d he explains. \u201cBut, as our pipeline grew, we realized we needed a more robust system that gives access to our data in real-time. From an oversight standpoint, we wanted to make sure we were in compliance because, as a sponsor, we\u2019re responsible for trial conduct. If you’re tied to a CRO and you’re using their systems, you lose the system if you leave the CRO.\u201d\n<\/p>\n
\nWhen choosing a CTMS, McAdory wanted a full-featured solution that would evolve as CG Oncology grew its trial portfolio. \u201cI was looking for efficiencies and ³Ô¹Ï±¬ÁÏ CTMS met all my requirements. Not only is it a centralized repository for trial management, it also has built-in analytics and dashboards. I can create my entire site list in CTMS, track how things are trending, and build customized reports,\u201d he says.\n<\/p>\n
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\nAlthough data migrations can be daunting, especially for smaller clinical teams, McAdory found the process to be quite smooth. \u201cWe worked with our implementation team at ³Ô¹Ï±¬ÁÏ to map information from our legacy system into ³Ô¹Ï±¬ÁÏ CTMS,\u201d he says. \u201cWhen you\u2019re doing data transfers, you\u2019re always worried that something might go wrong. But, going through the mapping process made it a lot easier.\u201d\n<\/p>\n
\n³Ô¹Ï±¬ÁÏ CTMS helps CG Oncology centralize planning, performance tracking, subject information, deadlines, oversight, and trial milestones. Now, McAdory\u2019s team has an auditable and reportable record of oversight activities to satisfy regulatory requirements. \u201cHaving a CTMS is a great advantage for us during inspections. We can easily show the FDA that we have a validated system and that we\u2019re in compliance with federal regulations,\u201d says McAdory.\n<\/p>\n
\n\u201cHaving a CTMS is a great advantage for us during inspections. We can easily show the FDA that we have a validated system and that we\u2019re in compliance with federal regulations.\u201d
\n\u2013 John McAdory, Vice President of Clinical Operations, CG Oncology<\/span>\n<\/p><\/blockquote>\n\nMcAdory advises biopharmas against relying on spreadsheets or documents for study tracking, even if they outsource most of their trial portfolios. \u201cIf you\u2019re not using a validated system and you get inspected, that\u2019s not going to fly with the FDA. The first thing they\u2019re going to ask is \u2018let me see your validation documents and what systems you\u2019re using,\u2019\u201d he explains. \u201cIf you have your own CTMS, you can capture everything from monitoring reports and metrics to protocol deviations to give you better oversight of your studies.\u201d\n<\/p>\n
\n\u201cIf you have your own CTMS, you can capture everything from monitoring reports and metrics to protocol deviations to give you better oversight of your studies.\u201d
\n\u2013 John McAdory, Vice President of Clinical Operations, CG Oncology<\/span>\n<\/p><\/blockquote>\nImproved oversight, improved outcomes<\/h2>\n
\nWith ³Ô¹Ï±¬ÁÏ CTMS, McAdory\u2019s team works faster and more efficiently with real-time access to trial data. \u201cBefore, we were keeping spreadsheets and dashboards in Excel. We were never sure: is the data real-time? If you update the report on Friday, did the data change by Monday when you sent it out?\u201d he remembers. \u201cNow, we can go into our CTMS at any time and trust that the information is accurate.\u201d\n<\/p>\n
\nNow that CG Oncology has modernized its CTMS, the company is looking beyond trial management toward a connected clinical ecosystem. \u201cWe\u2019re seeing the benefits of a platform approach across the entire company. It\u2019s really changing the way we work.\u201d\n<\/p>\n