Service 06 / 06
Functional Service Provider
Trained clinical staff embedded in your team, under your process.
Overview
Where you need capacity rather than a full outsourced study, we place experienced clinical research professionals into your programme — working to your SOPs, in your systems, reporting to your leads. Useful for enrolment surges, coverage gaps and building local presence without opening an entity.
- CRAs, CTAs, data managers and PV associates
- Work under sponsor SOPs and systems
- Scales up and down with programme demand
Capabilities
What this covers.
Each capability can be contracted on its own or as part of the full service line.
- 01
Clinical Research Associates
GCP-trained monitors deployed on your monitoring plan, in your CTMS, reporting into your clinical operations structure.
- 02
Clinical Trial Administrators & Coordinators
Document management, TMF maintenance, site correspondence and logistics support that keeps studies inspection-ready.
- 03
Data Management & Programming Resource
Data managers, medical coders and statistical programmers working within your validated environment and standards.
- 04
Pharmacovigilance Resource
Case processors and safety associates working in your safety database under your safety management plan.
- 05
Regulatory Affairs Resource
Local regulatory specialists handling in-country submissions and maintenance activity as an extension of your regulatory team.
- 06
Onboarding, Training & Oversight
Sponsor SOP training, documented competency records, performance oversight and continuity planning so a departure does not become your problem.
Deliverables
What you receive.
Concrete artefacts on an agreed schedule — so progress is verifiable rather than asserted.
- Role specifications and candidate profiles
- Sponsor SOP training and competency records
- Defined reporting and escalation structure
- Utilisation and performance reporting
- Continuity and handover documentation
Related services
Often engaged alongside this.
Next step
Scope a functional service provider engagement.
Share your protocol synopsis and target timeline. We come back with scope, assumptions and an indicative budget.