GCP · Sites · CROs · TMF
Clinical Quality
Assurance
Leaders in Guarding the Trials
Your Approval Depends On
Leaders in Guarding the Trials
Your Approval Depends On
Everything a clinical program produces rides on Good Clinical Practice: the protection of the people in the trial and the credibility of the data that comes out of it. Clinical quality assurance is the independent function that verifies both — auditing sites, vendors, and files against the promises the protocol made, before an inspector or an IRB does it for you. We build CQA programs for sponsors, run the audits, and prepare organizations for the BIMO and GCP inspections that decide whether the evidence counts.
The first document an inspector reads is the one the subject signed. It has to be perfect first.
ICH E6(R3) is blunt about it: the sponsor owns trial quality no matter how many layers execute it. Every tier below you is someone you must qualify, oversee, and audit — with evidence that the oversight happened. That ownership starts with naming the trial's critical-to-quality factors before the oversight plan is written, not after.
Quality tolerance limits, risk-based oversight plans, and the QA function that watches everything below — including itself.
Transfer-of-obligations that mean something, qualification audits before signature, and routine audits that test performance rather than paperwork.
PI oversight, consent conduct, source data, and drug accountability — audited on site, where the trial actually happens.
Central labs, randomization systems, imaging cores, and ePRO platforms — the tiers nobody audits until a dataset wobbles.
Site quality is observed in the workflow, the source, and the fridge log — not in the feasibility questionnaire.
A CQA program is a portfolio of distinct examinations, each with its own method and its own way of going soft. We run all six at the depth the risk deserves.
Consent, source, PI engagement, and accountability verified where the subjects are — routine, targeted, and pre-inspection.
Qualification before contract and performance audits after — testing the systems your obligations now run on.
Completeness, timeliness, and quality of the trial master file — the document an inspection reconstructs your trial from.
SAE flow from site to sponsor to authority, reconciled across databases and inside the clocks.
EDC build, edit checks, coding, and the audit trail between source and submission dataset.
When a signal fires — a whistleblower, a data anomaly, a site gone quiet — a rapid, defensible investigation.
A data anomaly, a site gone quiet — examined the way an inspector would, before it becomes a finding.
When the application files, FDA’s Bioresearch Monitoring program inspects the trial that produced it — sites and sponsor alike. EMA’s GCP inspectors do the same for the EU dossier. What they examine is knowable, which means it is preparable.
Evidence the investigator actually supervised: delegation logs that match reality, consent conducted properly, source that supports every CRF entry.
Monitoring reports and their follow-up, escalation of site issues, vendor oversight records, and the QA audits you are allowed to keep privileged but must prove existed.
Every pivotal endpoint traced backward: dataset to EDC to source, with the discrepancies explained before an inspector finds them.
Contemporaneous, complete, and inspectable in place — because “we can get that document” is not the same as having it.
To an inspector who was never at the site, the TMF is not a record of the trial. It is the trial.
Every clinical quality failure we have remediated was visible months before it mattered. These are the vital signs a CQA function is built to watch.
The same protocol deviation across sites is not noise — it is the protocol, the training, or the pressure talking.
Sometimes excellence; sometimes eligibility creep. The fastest site deserves the same scrutiny as the slowest.
Filing that lags the trial by months means the story is being written retrospectively, which inspectors can always tell.
A finding closed three visits running is not closed. Escalation paths exist for exactly this.
When the investigator stops appearing in the record — no notes, no signatures, no meetings — supervision has already left the building.
No queries, no meetings — supervision has already left the building. We watch for the silence.
Your CQA leads are former sponsor QA heads and GCP auditors who have qualified CROs, audited hundreds of sites across therapeutic areas, and hosted the inspections that followed the filing.
Risk-proportionate oversight as the new GCP actually frames it — not the checklist version of the old one.
Oncology, rare disease, vaccines, devices, and decentralized designs — each with its own GCP pressure points.
We have sat on both sides of the transfer-of-obligations, so our vendor audits test what actually slips.
CQA reports outside the clinical operations chain, and our findings stay honest because of it.
CQA connects the trial floor to the submission. These are the services sponsors most often engage alongside it.
GCP is one of five disciplines — the full good-practice estate, audited by one team.
Explore GxP →A BIMO-style rehearsal for sites and sponsor teams before the real inspection is scheduled.
Explore Mock Inspections →The protocols, CSRs, and submission documents your audited data ultimately lives in.
Explore Writing →Tell us about your program — the trials running, the vendors carrying them, and the inspection on the horizon. We’ll match you with a senior clinical QA lead, with a response within one business day. All inquiries are strictly confidential.
