\nLinical Americas knew they had to find a
\ndigital solution that could unify their globally dispersed teams and create efficiencies
\nat scale. After implementing ³Ô¹Ï±¬ÁÏ Clinical Operations, Linical sped their TMF delivery time to sponsors by 75% and cut study setup time in half. When the pandemic hit, they had the technical foundation in place to quickly adapt
\nto changing regulations and ensure business continuity during uncertain times.\n<\/p>\n
\nAs a CRO, Linical knew they needed to modernize their clinical operations systems to remain competitive.
\nSeveral years ago, the team moved from paper-based TMFs to a cloud file-sharing system. This was an
\nimprovement but still did not offer automated reporting, audit trails, or the compliance they needed.\n<\/p>\n
\n“Sponsors are looking for good technology solutions, and the fact that we use ³Ô¹Ï±¬ÁÏ Clinical
\nOperations and can demonstrate metrics is a great benefit.”
\n\u2013 Julie McHugh, Chief Operating Officer at Linical Americas<\/span>\n<\/p><\/blockquote>\n\n\u201cOur clients were hesitant to use our existing systems, which were not 21 CFR compliant,\u201d explained Julie
\nMcHugh, chief operating officer at Linical Americas. After a lengthy evaluation process, they chose ³Ô¹Ï±¬ÁÏ
\neTMF because it met their requirements and was user-friendly.\n<\/p>\n\nA few years after moving to ³Ô¹Ï±¬ÁÏ eTMF, Linical implemented ³Ô¹Ï±¬ÁÏ CTMS for study planning, site monitoring,
\nand risk management. The ability to customize the system to be client-specific was a huge benefit for Linical,
\nand one of the reasons they selected ³Ô¹Ï±¬ÁÏ CTMS.\n<\/p>\n\nThe team also liked the electronic trip reports, protocol deviation tracking, detailed reporting, and unification
\nwith ³Ô¹Ï±¬ÁÏ eTMF. \u201cWhen we moved from two platforms to one, we cut our study setup time in half. We\u2019re getting
\ntwice the value with ³Ô¹Ï±¬ÁÏ Clinical Operations because we are setting up the study once,\u201d said McHugh.\n<\/p>\n\n“We\u2019re getting twice the value with ³Ô¹Ï±¬ÁÏ Clinical Operations because we are setting
\nup the study once.”
\n\u2013 Julie McHugh, Chief Operating Officer at Linical Americas<\/span>\n<\/p><\/blockquote>\nMore Advanced Site Monitoring<\/h2>\n
\nMcHugh explained that with ³Ô¹Ï±¬ÁÏ eTMF and ³Ô¹Ï±¬ÁÏ CTMS they can permanently shift to a hybrid monitoring
\napproach of traditional as well as remote and central monitoring. This will allow them more flexibility in how
\nthey work with research sites.\n<\/p>\n\nElectronic trip reports have also increased visibility into the visit lifecycle, improving compliance and
\ntransforming the way they plan site visits. By including source data verification metrics directly in trip reports,
\n\u201cit\u2019s almost like having three different systems integrated into one,\u201d said McHugh.\n<\/p>\n\nReal-time metrics and reports provide insight and performance monitoring to ensure Linical is compliant with
\neach client\u2019s study plan. \u201cThe efficiencies from the eTMF Completeness Checklist report were a surprise for us,\u201d
\nsaid Lori McMullin, clinical systems administrator at Linical Americas.\n<\/p>\n\nShe explained that the team went from doing manual TMF tracking, which can take a month or more, to
\nreviewing the Completeness Checklist daily. \u201cIt shows us every document, where it is classified, who uploaded
\nit, and what status it\u2019s in. All in about 20 seconds. That transparency is a huge benefit and helps us meet
\nimportant study milestones for our clients.\u201d\n<\/p>\n\n“It used to take months to reconcile and deliver a TMF to a client, but with Vault eTMF,
\nit now takes approximately two weeks.”
\n\u2013 Julie McHugh, Chief Operating Officer at Linical Americas<\/span>\n<\/p><\/blockquote>\nQuicker Validation and Reconciliation<\/h2>\n
\nLinical\u2019s study teams and sponsors now have access to ³Ô¹Ï±¬ÁÏ eTMF and ³Ô¹Ï±¬ÁÏ CTMS, which has shortened
\nstudy timelines. Pre-defined workflows provide increased visibility and ensure compliance across departments.
\nThis teamwork has streamlined data validation and reconciliation. \u201cIt used to take months to reconcile and
\ndeliver a TMF to a client,\u201d said McHugh, \u201cbut with ³Ô¹Ï±¬ÁÏ eTMF, it now takes approximately two weeks.\u201d\n<\/p>\n\nRequired documents seamlessly flow from ³Ô¹Ï±¬ÁÏ CTMS into ³Ô¹Ï±¬ÁÏ eTMF and are properly classified
\nsystematically, reducing manual processes carried out by clinical research associates. This enables Linical
\nto always be inspection-ready.\n<\/p>\n\n³Ô¹Ï±¬ÁÏ eTMF utilizes the industry-standard TMF Reference Model with audit trails to demonstrate that the trial
\nworkflow was followed. It also helps ensure the studies pass inspections without any regulatory findings.
\n\u201cOur client success rate is remarkably high,\u201d said McMullin. \u201cWe have minimal to no findings at the end of the
\nstudy because of the unified system.\u201d\n<\/p>\nGlobal Consistency and Expansion<\/h2>\n
\nLinical continues to expand globally and strengthen their decentralized clinical trial offerings to provide more
\ncost-effective solutions for clients. \u201cSponsors are looking for good technology solutions, and the fact that
\nwe use ³Ô¹Ï±¬ÁÏ Clinical Operations and can demonstrate metrics is a great benefit,\u201d explained McHugh.
\nLinical\u2019s partnership with ³Ô¹Ï±¬ÁÏ has helped secure work and gives sponsors confidence in Linical\u2019s ability to
\nexecute trials faster.\n<\/p>\n\nSince seeing the benefits of the unified clinical operations platform, Linical is also evaluating adding ³Ô¹Ï±¬ÁÏ Study
\nStartup and ³Ô¹Ï±¬ÁÏ Clinical Data to their clinical environment to drive additional cross-team efficiencies. They also plan
\nto partner with research sites using ³Ô¹Ï±¬ÁÏ SiteVault to better facilitate remote monitoring.\n<\/p>\n