About
Meet Mital Jain, Clinical Research Quality Audit Consultant
16+ years helping sponsors, biotechs and CROs run clinical trials that stand up to FDA and EMA scrutiny.
Quality Auditing
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, from early-phase studies through global, multi-site programs.
I audit against ICH E6(R2)/E6(R3) Good Clinical Practice, FDA 21 CFR Parts 11, 50, 54, 56 and 312, and EMA expectations — always with a practical eye for data integrity (ALCOA+), patient safety and inspection readiness. My reports are clear, risk-ranked and built to drive real corrective action, not just check a box.
You work directly with me — an experienced auditor — not a rotating bench of juniors. That means sharper findings, faster turnaround, and advice grounded in real sponsor and CRO experience.
- Sponsor & CRO oversight and vendor qualification
- Investigator-site and TMF audits
- Mock FDA / EMA inspection readiness
- Root cause analysis & CAPA management
Track Record
Experience across big pharma, global CROs and emerging biotech
The discipline is the same whether the sponsor is a multinational or a clinical-stage innovator — but the pressures differ. I've worked across both.
- Merck
- IQVIA
- Q² Solutions
- PharPoint Research
- MindMed
Company names and images denote professional experience and engagements; they do not imply current endorsement or partnership.
Ready to make your trial inspection-ready?
Free initial consultation to scope your audit needs — usually a reply within one business day.