A quality system regulators respect.
Regulators expect quality management from the beginning of clinical development, not from the point at which someone asks to see it. But a full quality system built too early is expensive, unused, and usually abandoned.
The failure mode is predictable: a system is bought or built to look complete, nobody works to it, and at inspection the gap between the documented process and the actual one is the finding.
A QMS is worth having only if your team uses it. That argues for starting with the procedures you genuinely need and scaling as the organisation does.
Everything in the box.
Quality manual & policy
The top-level framework defining how quality is managed across your trials.
SOPs and work instructions
The procedures that operationalise your QMS. We set these up too.
Document & records control
Versioning, approvals, and an audit-ready evidence trail.
CAPA, deviations & risk
The processes regulators look for, sized to your stage.
A QMS that grows with you.
A QMS brought in too late adds time and cost at the worst point. One brought in all at once overwhelms a small team. Stages avoid both.
4 stages to full compliance
Each stage puts in place the procedures and requirements that help your development at that point, so the team never has to adopt everything at once.
Paced to your development
Stages run across your integration timeline, typically around a year, so quality work lands when it is needed rather than all up front.
No obligation to continue
You pay per stage. There is no commitment to buy the next one, and each stage stands on its own.
From £6,000 to start.
Pay per stage. Stop when you like.
Tell us where you are and we will scope the stages against your development plan.
- All the procedures required, around 40
- Training materials for your team
- Onsite training
From first call to done.
- 1
Start from a proven framework
A right-sized QMS template aligned to GCP, not enterprise bloat.
- 2
Tailor to your stage
We scale it to your team, trial, and risk profile.
- 3
Implement with you
We set it up, train your team, and make it run.
For the people who read everything.
The system covers the quality manual and policy, document and records control, training and competency, risk management, deviations, quality events and CAPA, vendor oversight, and internal audit and quality system review.
E6(R3) reframed GCP around risk-proportionate quality management, which makes proportionality a compliance position rather than a shortcut. A single-site early-phase study should not carry the same apparatus as a global programme, and a well-built system says so explicitly.
For device and combination-product companies the same phased approach applies against ISO 13485, EU MDR and the FDA Quality Management System Regulation. Tell us what you are developing and we will tell you which framework you are actually working to.
Bought alongside, not instead.
Start with a gap analysis
A structured review of your existing quality infrastructure against current expectations, producing a prioritised list of what is missing, outdated or unused.
Fractional QA support
QA expertise on demand (review, sign-off and advice) without carrying a permanent quality function.
Inspection readiness review
A focused check ahead of a scheduled inspection, covering the documents and decisions inspectors ask for first.
What is a clinical trial QMS?
A clinical Quality Management System is the documented framework (quality manual, policies, SOPs, and records) that ensures trials are conducted consistently and in line with GCP and regulatory expectations.
Read the full answer →When do I need a QMS for clinical trials?
Regulators expect quality management from day one of clinical development. The system can be lightweight early on and scale as you grow, but it should exist before you start trial activities.
Read the full answer →How is a QMS different from SOPs?
SOPs are the individual procedures; the QMS is the overarching system that organises them: the quality manual, policies, document control, CAPA, and risk processes that give your SOPs structure and oversight.
What is risk-based quality management under E6(R3)?
Identifying the factors that genuinely affect participant safety and data reliability in your trial, then concentrating controls there rather than applying the same intensity everywhere. It is a proportionality principle: a single-site early-phase study should not carry the same quality apparatus as a global programme.
What does audit-ready actually mean?
That your documented processes match what your team actually does, and that you can show it. Audit readiness is less about having documents than about traceability: decisions recorded when they were made, procedures followed as written, and evidence retrievable without a scramble.
Planning your first trial?
Tell us where you are. We'll get your SOPs and quality system sorted, so you're trial-ready, fast.
A reply from a person, usually within one business day.