Clinical Research Quality Assurance & GCP Compliance
Clinical research quality audits that keep your trials inspection-ready
I'm Mital Jain — an independent quality audit consultant with 16+ years auditing clinical trials for sponsors and CROs. Sponsor, CRO, vendor and investigator-site audits that keep your studies GCP-compliant and ready for the FDA.
- 16+Years auditing clinical trials
- GCPICH E6 · FDA · EMA aligned
- Sponsor & CROAudit experience
quality auditing
Quality Auditing
About Mital Jain
A quality auditor sponsors trust to find the gaps before regulators do
For more than 16 years I've helped pharmaceutical sponsors, biotechs and CROs run clinical trials that stand up to scrutiny — supporting organizations including Merck, IQVIA, Q² Solutions, PharPoint Research and MindMed.
I audit against ICH E6(R2)/E6(R3) GCP, FDA 21 CFR Parts 11, 50, 54, 56 and 312, and EMA expectations — with a practical eye for data integrity, patient safety and inspection readiness.
More about MitalAudit Services
Independent audits across the full trial lifecycle
From a single investigator-site audit to an ongoing quality partnership — every engagement is scoped to your risk, timelines and regulatory exposure.
Sponsor & Internal GCP Audits
Independent audits of your QMS, processes and study oversight to surface systemic risk before a regulator does.
Learn moreInvestigator-Site Audits
On-site or remote review of consent, source data, drug accountability and protocol adherence to protect data integrity.
Learn moreCRO & Vendor Qualification Audits
Due-diligence and for-cause audits of CROs, central labs and specialty vendors — outsource with confidence.
Learn moreMock FDA & EMA Inspection Readiness
A full dress-rehearsal inspection with a prioritized gap list so your team and documents are ready before the agency arrives.
Learn moreTrial Master File (TMF) Audits
Completeness, quality and inspection-readiness checks of paper TMF and eTMF against the DIA TMF Reference Model.
Learn moreCAPA & Root Cause Analysis
Root-cause investigation and CAPA plans that actually close findings and stand up to regulatory scrutiny.
Learn more"Data integrity, patient safety and inspection readiness — built into your study, not bolted on after a finding."
— Mital Jain, Quality Audit Consultant
How It Works
A clear, low-friction audit process
From first call to closed CAPA, you always know where you stand.
- 1
Scope & Plan
We define objectives, risk areas and standards, then I deliver a tailored audit plan and agenda.
- 2
Conduct the Audit
On-site, remote or hybrid review of documents, systems, data and interviews — thorough, but efficient.
- 3
Report & Findings
A clear, risk-ranked report with evidence and actionable recommendations — in days, not weeks.
- 4
CAPA & Follow-up
Root-cause support and CAPA verification so findings are genuinely resolved and inspection-ready.
Questions & Answers
Clinical research quality audit FAQ
A few common questions — see the full FAQ for more.
What does a clinical research quality auditor do?
A clinical research quality auditor independently evaluates clinical trials against Good Clinical Practice (GCP), regulatory requirements and the protocol. The auditor reviews sponsors, CROs, vendors and investigator sites to confirm that data is reliable, participants are protected and the study is inspection-ready — then documents findings and supports corrective and preventive action (CAPA).
What types of GCP audits do you conduct?
Sponsor and internal system audits, investigator-site audits, CRO and vendor qualification audits, Trial Master File (TMF) audits, computer-system and 21 CFR Part 11 audits, and mock FDA or EMA inspection-readiness assessments.
Do you audit remotely or on-site, and what locations do you serve?
Both. I perform on-site audits across the United States and remote or hybrid audits worldwide. I'm based in the Raleigh, North Carolina area and regularly support sponsors and CROs nationwide and internationally.
Ready to make your trial inspection-ready?
Free initial consultation to scope your audit needs — usually a reply within one business day.