The problem
Most sponsors do not need a whole CRO. They need one function that is not working.
Full-service outsourcing is sold as simplicity and often delivers the opposite: a layer of account management between you and the people doing the work, and a change order for anything not in the original scope.
The opposite failure is equally common. A sponsor keeps everything in house, one function falls behind, and the whole timeline waits for it while everyone insists the plan is fine.
Modular is the honest middle. Tell us which function is short and we staff that, with one accountable lead, and we leave the rest of your model alone.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
What we do
The functions, separately or together.
Study planning
Protocol feasibility, timelines and budgets built on assumptions someone will defend.
Operations
Site management, enrolment and day-to-day delivery.
Monitoring
Full-service or functional, risk-based by default.
Project management
A single owner of the plan, the risks and the escalations.
Vendor management
Selection, oversight and the awkward conversations when a vendor slips.
Rescue
Taking over a study that has drifted, starting with a real assessment.
For consultants
Roles we place in trial management.
Study leadership roles are scarce and move fast. If this is your background, being known to us before a role opens matters more than watching a board.
- Clinical Trial Managers
- Study Directors
- Clinical Programme Managers
- Vendor and Outsourcing Leads
- Feasibility Specialists
- Rescue and turnaround leads
Proof
One lead
However many functions you take, there is a single accountable owner.
Client testimonials for this discipline are being collected and will appear here once approved in writing by the clients concerned.
Questions
Questions we get asked.
Can we start with one function and expand?
Yes, and most clients do. Expanding is a scope conversation rather than a new procurement.
Who owns the study if you only run part of it?
You do. We own our function and its metrics, and we escalate across boundaries rather than stopping at them.
How is this priced?
Functional support is usually time and materials against an agreed FTE profile. Defined deliverables work better as fixed-scope.
Can you work inside our systems?
Yes, and it is usually better. Working in your CTMS and eTMF avoids a reconciliation exercise at the end.
What does rescue actually involve?
An assessment first, which sometimes concludes the study is in better shape than feared. Then a prioritised plan, staffed.
Related
Where to go next.
Talk to someone who has done this.
Hiring for it, or looking for the work. Either conversation is welcome.