Cloudbyz CTMS runs site feasibility inside the system. Study teams start from previous site records, send a customised feasibility survey from the CTMS, let sites correct their answers within a set window, track received and pending responses, filter sites by their answers to specific questions, and shortlist with a single toggle. Cloudbyz CTMS is a Salesforce-native clinical trial management system used by organisations from emerging biotechs to large pharma, global multinationals, CROs and device companies.
Why feasibility needs a proper record
Under 21 CFR 312.53, sponsors must select investigators who are qualified by training and experience, and ICH E6(R3) expects investigators to have the resources, staff and facilities to conduct the trial properly (ICH E6(R3), EMA Step 5). Feasibility answers are part of the evidence for how sites were chosen. When they live in email attachments and spreadsheets, that evidence is hard to show, and poor site choices show up later as slow enrolment and deviations.
Step by step
- Start from site history. Previous site records, including past studies and performance, are available before choosing who to survey.
- Customise the survey. A survey template is adjusted for the protocol, so standard questions stay consistent and study-specific ones are added.
- Send from the CTMS. Surveys go to selected sites from the system, and each response is linked to the site and study.
- Let sites correct answers. Sites can edit a submitted response within a time window the study team sets.
- Track responses. CRAs and operations leads see how many responses are received and how many are pending, site by site.
- Filter by answer. Sites can be filtered on their answers to specific questions, such as procedure capability or matching patient numbers.
- Shortlist with one toggle. Reviewed sites are shortlisted on the record, and move on to pre-study visits, contracts and activation in the same system.
What changes compared with email and spreadsheets
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Task
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Email and spreadsheets
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Cloudbyz CTMS
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Choosing sites
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Lists rebuilt from old files
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Start from site records
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Corrections
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New email, new version
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Edited within the response window
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Tracking
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Manual tracker
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Received and pending counts
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Comparing
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Answers copied into a sheet
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Filtered by question
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Selection record
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Scattered
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Shortlist decision on each site record
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See feasibility in Cloudbyz CTMS
The Cloudbyz team can walk through a feasibility survey from sending to shortlisting. Book a demo or visit cloudbyz.com.
