Most teams still track milestones such as site activation, first patient in and last patient out in spreadsheets updated weekly, then rebuild status reports by hand. Cloudbyz CTMS tracks milestones from the records that create them, such as executed agreements, approvals, initiation visits and enrolment from Cloudbyz EDC, so study, country and site status is live in dashboards. It is used by large pharma, global multinationals, biotechs, CROs and device companies.
How it works today
- Each CTM keeps a milestone tracker for their studies.
- Dates are copied in from emails, EDC reports and site updates.
- Every week, trackers are merged into a status report.
- By the time leadership reads it, some milestones have already moved.
Why milestones matter beyond reporting
- Regulatory notifications. Under the EU Clinical Trials Regulation, sponsors must notify each Member State concerned of the start of the trial, the first visit of the first participant, the end of recruitment and the end of the trial, generally within 15 days. A milestone missed in a tracker can mean a late notification.
- Sponsor oversight. ICH E6(R3) expects oversight proportionate to risk (ICH E6(R3), EMA Step 5). Slow activation and enrolment are risks that need to be seen early.
- Payments. Start-up fees, milestone payments and holdback releases depend on the same milestones.
Today versus Cloudbyz CTMS
|
Milestone
|
Today
|
Cloudbyz CTMS
|
|
Agreement executed
|
Email from contracts
|
Agreement status from Cloudbyz CTFM
|
|
Ethics and regulatory approval
|
Typed into a tracker
|
Recorded on the site record
|
|
Site initiation
|
Visit report emailed
|
Initiation visit completed in CTMS
|
|
First patient in
|
EDC report checked weekly
|
Enrolment from Cloudbyz EDC in real time
|
|
Last patient last visit
|
Reported by data management
|
Visit data from EDC
|
|
Status report
|
Built by hand
|
Live dashboards by study, country and site
|
For large pharma and global multinationals
With many studies and countries, manual trackers can't keep up, and country notification timelines multiply. Live milestones across the portfolio let leaders see which countries and sites are behind, and give regulatory teams the dates they need for each Member State without chasing study teams.
For biotechs and emerging sponsors
For a biotech, a single slow site can delay a whole study, and investors and boards ask for milestone dates. Live status from the records means a small team can answer those questions without rebuilding a tracker each time.
How Cloudbyz CTMS does it
Cloudbyz CTMS, built natively on Salesforce with Cloudbyz EDC, eTMF and CTFM, sets up study milestones from templates, updates them from the records that create them, and shows status in dashboards by study, country and site. Milestones also drive related payments in CTFM. Book a demo or visit cloudbyz.com.
