Team planner
How we size teams.
The rules the team planner uses, set out in full. They come from experience of running clinical operations teams, and they give a starting point: we confirm the team with you before anything is agreed.
CRAs: sites per full-time CRA
CRA time follows the number of sites and how they are monitored. On a standard study, one full-time CRA covers the number of sites below. Early-phase studies need more visits, so each CRA covers fewer sites. A complex study adds a quarter to CRA time (×1.25).
| Sites per CRA | Phase I | Phase II | Phase III | Device: Early feasibility | Device: Pivotal | Device: Post-market (PMCF) |
|---|---|---|---|---|---|---|
| Mostly on-site monitoring | 7 | 8 | 7 | 7 | 7 | 9 |
| Hybrid monitoring | 8 | 10 | 9 | 8 | 9 | 12 |
| Mostly remote monitoring | 11 | 13 | 12 | 11 | 12 | 15 |
A full-time CRA is 18 billable days a month.
One local CRA in every country
CRAs are sized country by country, so every site has a CRA who lives nearby, speaks the language and knows how local hospitals run research. Even a single site gets at least 0.2 FTE, so it has a named local CRA. Past one full-time role in a country, the work is shared between people.
When a lead CRA is needed, and when it is not
Experienced freelance CRAs rarely need a lead on a Phase I or II study, or on a device feasibility or post-market study. We suggest a lead CRA only on a Phase III or pivotal device study with 8 or more sites, to keep monitoring consistent between CRAs. You can add or remove one either way.
Project management
A clinical project manager starts at 0.3 FTE, adds 0.04 FTE for each site and 0.05 FTE for each extra country, because every country adds coordination. Past one full-time role the work is split between people, up to 3. Leave the role off if your own project manager will lead the UK and European sites.
Regulatory time is concentrated at start-up
For medicines, the planner allows 1 day a month plus 0.4 of a day for each country, between 2 and 8 days a month: one UK submission to the MHRA and one EU application through CTIS. Device investigations have no single EU application, so each country adds more: 1 day plus 0.6 of a day per country, between 2 and 10 days. That is the time for amendments once you are approved. While the initial submissions go in, regulatory time is about three times higher.
CTA time follows the number of sites
A clinical trial assistant keeps the trial master file filed and tracked. The planner allows 0.2 FTE plus 0.03 FTE for each site, between 0.2 FTE and full time.
How the team changes from start-up to close-out
Each role needs a different share of its sized time at each stage of the study.
| Stage | Project manager | Lead CRA | CRAs | Regulatory | CTA |
|---|---|---|---|---|---|
| Start-up | 100% | 50% | 50% | 300% | 100% |
| Enrolment and treatment | 100% | 100% | 100% | 100% | 100% |
| Close-out | 70% | 70% | 60% | 50% | 100% |
- Start-up: Regulatory time is about three times higher while the initial submissions go in. CRAs cover site selection and initiation visits.
- Enrolment and treatment: The team as sized above. CRA time is at its peak.
- Close-out: CRA time tapers as sites close. Filing completes the trial master file.
The planner shows its reasoning for every role, and you can change the time on any of them. Try the team planner
Want us to check your plan?
Tell us about your study and we'll confirm the team and the time each role needs in a written quote.