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. From sponsor and vendor audits to investigator-site reviews and mock FDA inspections, I help your studies meet GCP and regulatory expectations — before an inspector finds the gaps.

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  • 16+Years auditing clinical trials
  • GCPICH E6 & FDA / EMA aligned
  • Sponsor & CROAudit experience

16 years of quality experience across leading sponsors & CROs

  • Merck
  • IQVIA
  • Q2 Solutions
  • PharPoint Research
  • MindMed
16+ Years in Clinical
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. My career spans quality assurance and auditing roles supporting organizations including Merck, IQVIA, Q² Solutions, PharPoint Research and MindMed — across 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, EMA expectations and your own SOPs — 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.

  • Sponsor & CRO oversight and vendor qualification
  • Investigator-site and TMF audits
  • Mock FDA / EMA inspection readiness
  • Root cause analysis & CAPA management
Work with Mital

Audit Services

Independent quality audits across the full clinical trial lifecycle

Whether you need a single investigator-site audit or an ongoing quality partner for your study portfolio, every engagement is scoped to your risk, your timelines and your regulatory exposure.

Sponsor & Internal System Audits

Independent audits of your QMS, processes and SOPs to confirm GCP compliance and surface systemic risk before it reaches a regulator.

Investigator-Site Audits

On-site or remote review of source documents, informed consent, IP accountability and protocol adherence to protect data integrity and patient safety.

CRO & Vendor Qualification Audits

Due-diligence and for-cause audits of CROs, central labs and specialty vendors so you can outsource with confidence and document oversight.

Mock FDA / EMA Inspection Readiness

Full dress-rehearsal inspections — TMF, systems and staff interviews — with a prioritized gap list so your team walks into the real inspection prepared.

Trial Master File (TMF) Audits

Completeness, contemporaneousness and inspection-readiness checks of paper and eTMF against the DIA TMF Reference Model and ICH GCP.

CAPA & Root Cause Analysis

Practical root-cause investigation and corrective/preventive action plans that close findings for good and demonstrate continuous improvement.

Audited against: ICH E6(R2)/E6(R3) GCP 21 CFR Part 11 21 CFR 50 / 54 / 56 / 312 EMA / EU CTR ALCOA+ Data Integrity DIA TMF Reference Model

Track Record

Experience that spans big pharma, global CROs and emerging biotech

Quality is the same discipline whether the sponsor is a multinational or a clinical-stage innovator — but the pressures differ. I've worked across both.

16+Years in clinical QA & auditing
5Leading sponsors & CROs supported
GlobalMulti-site & international studies
GCPICH, FDA & EMA frameworks
  • Merck
  • IQVIA
  • Q² Solutions
  • PharPoint Research
  • MindMed

Company names denote professional experience and engagements; they do not imply current endorsement or partnership.

How It Works

A clear, low-friction audit process

From first call to closed CAPA, you always know where you stand.

  1. 1

    Scope & Plan

    We define objectives, risk areas and standards, then I deliver an audit plan and agenda tailored to your study.

  2. 2

    Conduct the Audit

    On-site, remote or hybrid review of documents, systems, data and interviews — thorough but respectful of your team's time.

  3. 3

    Report & Findings

    A clear, risk-ranked report with observations, evidence and actionable recommendations — typically within days, not weeks.

  4. 4

    CAPA & Follow-up

    I support root-cause analysis, CAPA development and verification so findings are genuinely resolved and inspection-ready.

Why Creative Quality Solutions

Senior-level auditing, without the overhead of a large firm

You work directly with an experienced auditor — not a rotating bench of juniors. That means sharper findings, faster turnaround and advice grounded in 16 years of real sponsor and CRO experience.

  • Independent & objective. An outside set of expert eyes regulators respect.
  • Inspection-focused. Every finding is framed around real FDA/EMA risk.
  • Practical reporting. Risk-ranked, evidence-based, and easy to act on.
  • Flexible delivery. On-site, remote or hybrid, US and international.
  • Responsive. Direct access to your auditor from first call to closeout.
  • Confidential. Discreet handling of your data and findings, always.

Questions & Answers

Clinical research quality audit FAQ

Common questions from sponsors, biotechs and CROs about quality audits 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 Greater Princeton, New Jersey 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 do I request a consultation with Mital Jain?

Call or text 609-442-6386, email Mitald522@gmail.com, or submit the contact form below. Initial consultations to scope your audit needs are free.

Get in Touch

Let's make your trial inspection-ready

Tell me about your study and your audit needs. I'll respond personally — usually within one business day — to scope how I can help.

Prefer email? Reach me directly at Mitald522@gmail.com.