Cloudbyz CTMS study templates let teams set up a new study from a proven starting point instead of a blank record: milestones, visit plans, monitoring report and letter templates, site document checklists and feasibility surveys come pre-defined, then are adjusted for the protocol. 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 consistent set-up matters
ICH E6(R3) asks sponsors to build quality into trial design and to focus oversight on what is critical to quality (ICH E6(R3), EMA Step 5). When each study is set up differently, monitoring reports ask different questions, document checklists miss items, and milestones can't be compared across the portfolio. Inspectors notice inconsistency, and leaders can't see which studies are behind.
What can be templated
|
Template
|
What it sets up
|
Benefit
|
|
Study milestones
|
Standard milestones by phase or study type
|
Comparable timelines across studies
|
|
Visit plan
|
Visits and procedures from the schedule of assessments
|
Fewer manual set-up errors
|
|
Monitoring report and letters
|
Report sections, follow-up letter wording, timelines
|
Consistent monitoring across CRAs
|
|
Site document checklist
|
Essential documents by country
|
Fewer missing documents at activation
|
|
Feasibility survey
|
Standard questions plus study-specific ones
|
Comparable site responses
|
|
Issue and deviation categories
|
Standard categories and severities
|
Trends visible across studies
|
How templates work in practice
- Choose the template that fits the study type, phase or sponsor.
- Adjust for the protocol, adding study-specific visits, procedures and questions.
- Reuse across studies, so every new study starts with what the last one learned.
- Update centrally, when an SOP or regulation changes, so new studies pick up the change.
How Cloudbyz CTMS supports templates
Cloudbyz CTMS is built natively on Salesforce, so templates, fields and workflows are configured rather than custom-coded. Cloudbyz lists AI-assisted study planning, including visit plan creation from the protocol, among its CTMS capabilities. Because Cloudbyz CTFM, EDC and eTMF share the platform, a visit plan set up once can drive site budgets and payments, and document checklists link to the TMF. Which templates are used, and who can change them, depends on configuration.
See study templates in Cloudbyz CTMS
Book a demo or visit cloudbyz.com.
