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Clinical study metrics and oversight tool
Background
4Site Clinical, the latest tool under development by A&O, has been designed to be more of a one-stop-shop approach by allowing a multi-functional study team access to a single tool which will not only show study data at various levels (therapeutic-wide down to patient level detail), but will also show potential clinical data issues, data backlogs and enable a more proactive approach to the overall management of a clinical trial study.
The general concept is this: depending on what our client wishes to include, 4Site Clinical will reflect the clinical trial. Like an orange, a trial has many segments to it (sample tracking, eCRF backlogs, query backlogs, visit backlogs, visit forecasting, patient visit calendars, critical query lists, site performance indicators, lab data, etc). All segments come together, under the skin of the orange, into a single tool.
Management of clinical data and effective study oversight is of paramount importance at the CRO but even more so at the Sponsor level. This has been emphasized with ICH GCP E6 (R2) Addendum. We'll have a summary of that posted to our blog very soon. 4Site Clinical will help support study teams demonstrate oversight activities with a unified tool, and report outputs from it.
Further resources
This can be especially achieved via 4Site Clinical’s main reporting feature. The concept of this reporting feature is that the end user can build their own customised PDF reports (for example, site monitoring visit checklist, DM update, study status reports). The user can select the elements they wish to include, in their desired order, at any level, and at the press of a button PDFs are generated. These can include visualisations, data listings, but also programmed findings that actually explain to your wider team what action is required in order to clear backlogs. “This frozen sample is on site” or “this (named) visit is overdue”, “these are the dates of the next visits for this patient” or indeed other programmed findings, such as patients who should not have had certain data collected due to consent withdrawal. All in one tool and created automatically.
The days of TCs and, “everyone know what to do?” followed by silence may be a thing of the past. Simply upload the outputs and everyone’s tasks are coordinated that much better, and oversight has been clearly demonstrated by the very documentation that 4Site Clinical produces.
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