Medical Device Clinical Project Management: On Time, On Budget, Inspection-Ready
REGHELPS project-manages medical device clinical investigations, PMCF studies and IVD performance studies from start-up to final report. One accountable project manager controls timelines, budget, sites, vendors, monitoring, data and safety reporting, so your study delivers the evidence your regulators need.
What is medical device clinical project management?
Clinical project management is the planning, coordination and control of a clinical study so it meets its scientific goals, regulatory requirements, timelines and budget. For medical devices, it covers clinical investigations, PMCF studies and IVD performance studies under ISO 14155, EU MDR, FDA and national rules.
Most device studies that fail do so for operational reasons: slow approvals, sites that do not recruit, poor data quality or late safety reporting. Strong project management catches these problems early, when they are still cheap to fix.
The 5 phases of a medical device clinical study
What happens in each phase, and what we manage for you.
| Phase | Typical duration | Key milestone |
|---|---|---|
| Start-up | 3–6 months | First patient in |
| Enrolment | Depends on sample size and sites | Last patient in |
| Conduct and follow-up | As set by the protocol | Last patient, last visit |
| Close-out | 1–3 months | Database lock |
| Reporting | Within 1 year of study end in the EU | Final clinical investigation report |
Responsibilities of the sponsor, CRO and sites
A clear split of tasks avoids gaps and duplication. This is our typical model, agreed in writing for each study.
| Activity | Sponsor | REGHELPS (CRO) | Sites and investigators |
|---|---|---|---|
| Overall study responsibility | Accountable | Supports | Responsible at site |
| Protocol and study documents | Approves | Writes and maintains | Provide input |
| Ethics and regulatory approvals | Signs as sponsor | Prepares and submits | Local submissions where needed |
| Site selection and contracts | Approves | Runs feasibility and contracts | Sign agreements |
| Patient recruitment and treatment | Oversees | Tracks and supports | Recruit and treat patients |
| Monitoring and data management | Oversees | Performs | Enter data and resolve queries |
| Safety reporting | Reports to authorities | Collects, assesses and prepares reports | Report events to sponsor |
| Final report | Approves | Writes | Review as needed |
The plans we set up and run for every study
How risk-based monitoring works
Effort goes where it protects patients and data most, in line with ISO 14155:2020.
The 8 KPIs we report to you every week
How REGHELPS manages your study
From kick-off to final report, with one accountable team.
- 1
Kick-off and planning
Project planWe agree scope, roles, timelines and budget, and set up all study plans.
- 2
Approvals and site start-up
Start-upWe manage submissions, site contracts, device logistics and site initiation.
- 3
Enrolment management
RecruitmentWe track enrolment weekly and act early when sites fall behind.
- 4
Monitoring and data
ConductWe run risk-based monitoring and keep data clean and current.
- 5
Safety and quality
OversightWe manage safety reporting, deviations and the sponsor file.
- 6
Close-out and report
DeliveryWe lock the database, close sites and deliver the final report.
Why device studies run late, and how we prevent it
Our clinical project management services
Clinical project management FAQs
What does a clinical project manager do in a medical device study?
The clinical project manager plans and leads the study from start-up to final report: timelines, budget, sites, vendors, monitoring, data management, safety reporting and communication with the sponsor. They are the single point of accountability for delivering the study on time, on budget and to ISO 14155.
Who is responsible for the study: the sponsor or the CRO?
The sponsor keeps overall responsibility under ISO 14155 and EU MDR. The sponsor can delegate tasks to a CRO, but the delegation must be documented in writing and the sponsor must oversee the CRO’s work.
What is risk-based monitoring?
Risk-based monitoring focuses effort on the data and processes that matter most for patient safety and study results. It combines central review of data trends with targeted on-site visits, instead of checking every data point at every site. ISO 14155:2020 supports this approach.
What is the sponsor file or trial master file?
It is the complete set of essential study documents, such as the protocol, approvals, contracts, monitoring reports and safety records. It must be kept current and inspection-ready, as regulators and Notified Bodies can review it.
How long does study start-up usually take?
Typically 3 to 6 months from final protocol to first patient enrolled, covering ethics and regulatory approvals, site contracts, device supply and site initiation. Multi-country studies or complex approvals can take longer.
How do you keep patient enrolment on track?
By choosing sites with proven patient numbers during feasibility, setting realistic enrolment targets, tracking enrolment weekly against plan and acting early: adding sites, supporting site staff or adjusting eligibility criteria through a protocol amendment where justified.
Need a study delivered on time and on budget?
Tell us about your study using the form below and we'll propose a project plan and budget.
