Questions & Answers
Clinical research quality audit FAQ
Common questions from sponsors, biotechs and CROs about quality audits, GCP and inspection readiness.
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, process and SOP audits, computer-system and 21 CFR Part 11 compliance audits, and mock FDA or regulatory inspection-readiness assessments.
What is the difference between a sponsor audit and a regulatory inspection?
A sponsor audit is a planned, independent quality check arranged by the trial sponsor (or a consultant on their behalf) to verify GCP compliance before problems escalate. A regulatory inspection is conducted by an authority such as the FDA or EMA and can lead to formal findings. Sponsor audits and mock inspections are how you prepare so a real inspection goes smoothly.
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.
Which regulations and guidelines do you audit against?
ICH E6(R2) and E6(R3) Good Clinical Practice, FDA 21 CFR Parts 11, 50, 54, 56 and 312, EMA and other applicable national regulations, plus the study protocol, the sponsor's SOPs and applicable data-integrity (ALCOA+) principles.
How do you help a study prepare for an FDA inspection?
I run mock inspections that mirror an FDA or EMA visit: reviewing the TMF, source documents and systems, interviewing staff, identifying gaps, and delivering a prioritized findings report with a practical CAPA plan so your team is confident and inspection-ready.
How quickly can you start an audit?
It depends on scope and travel, but I can typically agree an audit plan within days of an initial call and schedule the audit around your timelines. For-cause and pre-inspection work can be expedited.
How do I request a consultation with Mital Jain?
Call or text 609-442-6386, email Mitald522@gmail.com, or submit the contact form. Initial consultations to scope your audit needs are free.
Ready to make your trial inspection-ready?
Free initial consultation to scope your audit needs — usually a reply within one business day.