\nEuropean biotech company Alvotech is driving TMF compliance and efficiencies across its growing portfolio. With ³Ô¹Ï±¬ÁÏ eTMF, it implemented an industry-recognized solution, reduced manual activities, and improved compliance.\n<\/p>\n
\nThe company\u2019s clinical team now manages sponsor documents in its ³Ô¹Ï±¬ÁÏ eTMF while its CRO partners work in their own eTMF systems and transfer documents to Alvotech at the end of each study.\n<\/p>\n
Over the past 10 years, clinical trials have become more complex and increasingly challenging to run. Although some small- and medium-sized companies still manage clinical trial master files (TMFs) manually and on paper, they\u2019re typically working within narrow parameters \u2014 running a limited number of trials or relying on one contract research organization (CRO) to manage TMFs.\n<\/p>\n
\nAs companies grow, pipelines diversify, and external business conditions change, the limitations of manual paper-based tracking become increasingly clear. This is especially true when unexpected events occur such as COVID-19 lockdowns, as well as during virtual inspections and when regulations are enacted such as the European Union Clinical Trials Regulation (EU CTR).\n<\/p>\n
\nAlthough smaller biotechs might be concerned about the cost and time required to implement and manage an eTMF system, the right solution and operating model make it feasible.\n<\/p>\n
\nAs Alvotech\u2019s study and site volume increased, clinical leaders needed to maintain compliance for sponsor documents and position the company for growth. They ultimately implemented a standard ³Ô¹Ï±¬ÁÏ eTMF configuration that enabled rapid deployment.\n<\/p>\n
\n\u201cWe know that a sponsor must have a TMF,\u201d said Alvotech\u2019s head of clinical operations, Ruth Ruffieux. \u201cIt is absolutely appropriate to delegate most of the management to CROs, but there will generally be a set of documents that need to be managed by the sponsor. You need to show auditors where all the documents are held \u2014 by both sponsor and CRO.\n<\/p>\n
\n\u201cWe feel this approach is a great way to meet both parties’ needs and a good starting model for a growing company.\u201d\n<\/p>\n
\nAlvotech needed an electronic system to track document versions, file documents correctly, and report on completion status \u2014 as well as to maintain study archives for its growing portfolio. As Alvotech moves into new therapeutic areas and works with more contract partners in the future, it needs more flexible and effective solutions.\n<\/p>\n
\nAlvotech was already using ³Ô¹Ï±¬ÁÏ RIM and Quality suites, and its managers knew they could leverage connections to streamline cross-functional business processes and submissions. They also knew that ³Ô¹Ï±¬ÁÏ eTMF is a validated and industry-recognized solution for managing documents in real-time as the TMF is generated. They were confident that it would ensure a constant state of inspection readiness.\n<\/p>\n
\nWith a core team of five employees, Alvotech rolled out Vault eTMF in six weeks.\n<\/p>\n
\n\u201cThe six-week timeline seemed challenging, but we were able to accomplish it in close collaboration with our ³Ô¹Ï±¬ÁÏ colleagues,\u201d Ruffieux said. \u201cThe quick implementation enabled us to prepare for any potential health authority inspections. We know that the first place they will go is the eTMF.\u201d\n<\/p>\n
\n Alvotech\u2019s expedited ³Ô¹Ï±¬ÁÏ eTMF deployment went from concept to go-live in just six weeks.
\nTo make this work, clinical leaders recruited a core cross-functional team of technically skilled and enthusiastic employees with diverse roles, and dedicated them to defining the rollout strategy. The project\u2019s success rested on three main principles:\n<\/p>\n
\nInspections require that sponsors pay particularly close attention to metadata details, to address questions such as: <\/p>\n
\nIn the past, users had to be physically present in the office to access and update paper files, and the company was unable to run reports or capture information about how documents were generated, information that inspectors required. Alvotech can now run reports, quickly identify missing documents, and compare the number of non-final to final documents to verify that documents are approved and signed in a timely manner. This transparency eliminates the need for forensic searches at the end of a trial, and enables the team to adhere to SOPs more easily. With the new application, the clinical team can also grant inspectors direct access, a regulatory expectation, more easily.\n<\/p>\n
\nVault eTMF also enables automation that drives efficiencies in the company\u2019s TMF operations. Users can generate documents from templates within the system, instead of having to create them externally and upload them manually. This capability reduces the risk of users saving documents on laptops or shared drives and failing to file finalized documents properly in the eTMF.\n<\/p>\n
\n\u201cWe reduced manual activity tracking and document uploads,\u201d Ruffieux said. \u201cWe avoid people working offline and moving to their next activity. Now, they work in the eTMF system.\u201d\n<\/p>\n
\nFor key documents such as the protocol, informed consent, and study plans, this approach establishes a strong audit trail and makes them easy to find.\n<\/p>\n
\nThe company\u2019s new operating model allows CROs to continue working in their own systems with their established processes, while equipping Alvotech with a mechanism to manage sponsor documents and study archival effectively. the company can now manage key documents, including:<\/p>\n
\nRuffieux noted: \u201cWhether we work with a CRO that uses Vault eTMF or a non-³Ô¹Ï±¬ÁÏ system, we have mechanisms to transfer their TMFs to us in-house so we have the complete TMF on the sponsor side.\u201d This includes TMF Transfer<\/a>, a feature that eliminates manual end-of-study migrations.\n<\/p>\n \nAs Alvotech expands from a small to a medium-sized biotech, the company is seeing direct benefits from using Vault eTMF. In addition to enabling a rapid six-week rollout, the new application has relieved users of tedious document uploads, reduced manual data tracking, and improved collaboration with study partners.\n<\/p>\n \nAlvotech is now better equipped to grow and respond to new regulations, confident that its clinical team is driving TMF quality and completeness.\n<\/p>\nStreamlining TMF management<\/h2>\n