Before the first trial activity
Quality management applies from the first activity that affects a trial, not from first patient in. Selecting a CRO, writing the protocol, choosing sites and preparing ethics and regulatory submissions are all quality-relevant, and an inspector can look back at how they were done. If those decisions were made without procedures, there is nothing to show they were controlled.
What usually forces the issue
- Investor due diligence: investors increasingly ask to see the SOP list and quality system.
- Partner and CRO qualification: providers and partners may audit you before they sign.
- Your first submission: ethics and regulatory applications are made in the sponsor's name and on the sponsor's responsibility.
- Inspection: the MHRA inspects sponsors, and a sponsor with no quality system is a significant finding.
It is much easier to put a system in place before these arrive than while one is under way.
What lightweight looks like at the start
A first-trial QMS does not need every procedure on day one. It needs:
- A quality policy and a short quality manual
- Document control and training procedures
- Risk management
- Vendor selection and oversight
- Quality events, deviations and CAPA
- A trial master file procedure
That core can be in place within weeks, and gives every later procedure somewhere to live.
Scaling as you grow
Add procedures as your activities grow: safety and monitoring procedures as trials start, audit programmes as vendors multiply, and management review as the team grows. A system built to scale avoids the rework of replacing a stopgap later. Medical device companies should also see when medtech needs a QMS.
Our QMS setup service starts with this core and scales it with you.