GCP quality systems
GCP-compliant quality systems, SOPs, and training, built and run to ICH E6(R3).
All practices
Clinical Trial Compliance & GCP Consulting
GCP quality systems, sponsor and CRO oversight, trial master file management, and inspection readiness. For sponsors and biotechs across the EU, UK, and US, aligned to ICH E6(R3).
What we do
MRC supports sponsors and biotechs across the clinical trial lifecycle, from a single engagement to complete, ongoing oversight.
Sponsor oversight
Independent oversight of trials and delegated activities, with the oversight records inspectors expect to see.
Audits
We audit investigator sites, vendors, CROs, and systems, with gap analysis and CAPA management that stands up to scrutiny.
More clinical trial services
CRO and vendor oversight
We select, qualify, and oversee CROs and vendors against contract, service levels, and regulatory obligations.
Trial master file management
Trial master file set-up, health-checks, and remediation, kept complete, contemporaneous, and inspection-ready.
Risk-based quality management
Risk-based quality frameworks, critical-to-quality factors, and risk-proportionate monitoring.
Protocol and study-design review
We review protocols, feasibility, and endpoints for regulatory compliance and operational deliverability.
Trial safety reporting
SAE and SUSAR reporting, Development Safety Update Reports, and the interface with pharmacovigilance.
MHRA · EMA · FDA
GCP inspection readiness
Authorities inspect more frequently and increasingly by remote and hybrid methods. We prepare your trial, your people, and your trial master file to a standard where an inspection is a formality rather than a fire drill.
GCP system audit and gap analysis
An independent audit against ICH E6(R3) and the applicable EU CTR, UK, and US requirements, delivered as a prioritised, CAPA-ready findings report.
Mock inspections
A realistic MHRA, EMA, or FDA GCP mock inspection, including document requests, staff interviews, and a mock inspection report.
TMF and document readiness
Review and remediation of the trial master file and the records an inspector asks for first.
Findings and CAPA response
Drafting and managing responses to inspection findings, with corrective actions that hold.
From a first trial to multi-region programmes
We scale support from a single review or a first trial through to strengthening sponsor oversight across multiple trials and regions.
Emerging biotech
Running a first trial and standing up trial oversight and quality systems for the first time.
Established sponsor
Running multiple trials across regions and strengthening sponsor oversight at scale.
Functions in transition
Remediating, restructuring, or outsourcing an existing clinical operation under pressure.
Compliant on paper, and defensible under GCP inspection
We combine hands-on regulatory experience with a compliance-first mindset, giving you a trial that holds up in front of an MHRA, EMA, or FDA inspector. Every recommendation is mapped to the controlling rule and sized to the phase and size of the trial.
Mapped
Every recommendation traced to its rule
ICH reference, CTR article, or CFR citation: never advice without a source.
Proportionate
Sized to your trial
A single review, a TMF remediation, or full sponsor oversight, scoped to the phase and size of the trial.
Defensible
Built for the inspection ahead
Mock inspections and findings-response strategy drawing on direct health-authority experience.
Standards we work to
EU · UK · US
ICH E6(R3)
Good Clinical Practice
EU CTR
Reg (EU) 536/2014 · CTIS
UK
MHRA · UK clinical trials regulations
FDA
21 CFR Parts 11, 50, 54, 56, 312
Discuss a trial, a programme, or an upcoming inspection
Whether you are running a first trial, strengthening sponsor oversight, or preparing for a GCP inspection, tell us where you are and we will come back to you promptly.