Clinical Quality Assurance
Ready long before the inspector arrives.
The integrity of your clinical data and the safety of your trial participants are decided long before an agency ever knocks. We build the quality behind your studies, audit it the way an inspector would, and make sure what you file survives the scrutiny it will face.
Readiness, Not Reaction
Any auditor can hand you a report. We find what the inspector will find, while there is still time to fix it.
A GCP finding discovered in an FDA or EMA inspection can cost you an approval. Found in a proactive audit, it is a task on a list. Our senior quality leaders have sat on the agency side of the table and the sponsor side of it. We bring that eye to your trials early, so quality is built in rather than inspected for, and so inspection day is a formality instead of a crisis.
Capabilities
The full clinical quality function.
GCP Audits
Independent, risk-based audits across every party and artifact in your trial, run to ICH GCP and current regulatory expectations.
- Investigator site audits
- Sponsor, CRO, and vendor audits
- Trial Master File (TMF/eTMF) audits
- Database, GCLP, and GLP audits
- For-cause and due-diligence audits
Inspection Readiness
Everything required to walk into an FDA BIMO or EMA GCP inspection with confidence, rehearsed in advance.
- Readiness gap assessments
- Mock inspections with former agency inspectors
- Storyboards and narrative preparation
- Inspection hosting and back-room support
- Response and commitment management
CAPA & Remediation
When findings surface, the difference between a durable fix and a repeat observation is root-cause rigor. We bring both.
- Root-cause analysis
- CAPA development and management
- Effectiveness checks and closure
- Systemic and cross-study remediation
- Response to inspection findings (483, EIR)
Quality Systems & Oversight
A clinical quality system right-sized to your program, plus the sponsor oversight that regulators now expect you to own.
- Clinical QMS design and right-sizing
- SOP development and training
- Vendor qualification and CRO oversight
- Risk-based quality management (ICH E6)
- Quality agreements and metrics
What the Inspector Checks
We test all of it, first.
A GCP inspection follows the evidence into the corners most programs overlook. We audit against the same scrutiny, so nothing surfaces for the first time in front of the agency.
Protocol Adherence
Deviations, eligibility, and conduct against the approved protocol.
Informed Consent
Process, versions, timing, and documentation for every subject.
Source Data & ALCOA+
Attributable, contemporaneous, and complete source records.
Safety Reporting
AE and SAE capture, causality, and reporting timelines.
IP Accountability
Investigational product receipt, storage, dispensing, and reconciliation.
Delegation & Training
Qualified staff, documented delegation, and current training.
TMF Completeness
A contemporaneous, inspection-ready trial master file.
Data Management
Query handling, database integrity, and system validation.
How We Engage
Two ways in, whatever the moment demands.
Proactive Partner
Quality built in from the start.
We embed as your clinical quality function across a program or portfolio, keeping you inspection-ready every day rather than scrambling before one.
- Ongoing audit program and schedule
- Clinical QMS and SOP ownership
- Vendor and CRO oversight
- Continuous inspection readiness
Rapid Response
When the clock is already running.
An inspection notice, a for-cause signal, or a critical finding. We deploy senior quality leaders fast to stabilize the situation and protect the program.
- Pre-inspection readiness sprints
- For-cause and diligence audits
- Inspection hosting and support
- Finding response and remediation
Work With Us
Make inspection day a formality.
Tell us where your trials stand and what is ahead. We will pair you with a senior clinical quality leader and respond within one business day.
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