Welcome

Sound Compliance. Strong Partnerships.

GCP Compliance Expert, Inspection Readiness, Building Quality Systems

+1 (816) 797-5555

Hi, I'm Lisa Martin

I am your partner in GCP compliance.

Successful clinical research programs thrive on collaboration and integrity. I work alongside clients as an extension of their team, guiding quality practices that strengthen partnerships, reduce risk, and ensure every clinical trial stands up to inspection. I approach each trial as if it were my own, with the same care, accountability, and attention to detail expected of a trusted internal partner.

I am a seasoned clinical research professional with over 25 years of leadership across Sponsor, CRO, and site settings. I’ve led global teams and initiatives spanning clinical operations, quality assurance, service provider oversight, and inspection readiness. My background includes driving compliance with ICH GCP, FDA, TGA, MHRA and EMA requirements, managing site and service provider performance, and building scalable quality systems that support high-quality clinical trial execution. I bring a strategic, cross-functional approach to advancing clinical research excellence.

CV upon request.

Certifications:

RQAP-GCP: Registered Quality Assurance Professional in Good Clinical Practice - SQA
CCRP: Certified Clinical Research Professional - ACRP
Lean Six Sigma Green Belt - Six Sigma Global Institute
Myers Briggs Type Assessment Certification, Step 1 and 2

Learn more

What to expect when we work together:

How We Work Together

Every engagement begins with a conversation directly with me. I will take time to understand your organization, your current challenges, and what success looks like for your team before recommending any approach.

From there I work as a true extension of your team — not as an outside vendor dropping in with a checklist, but as a trusted partner who is invested in your outcomes. Whether you need targeted support for a specific challenge or ongoing quality oversight across your portfolio, engagements are tailored to fit your needs and your timeline.

Typical engagements look like this:

Project Based: A defined scope with clear deliverables and timeline. Well suited for inspection readiness assessments, SOP development, ICH E6(R3) gap analyses, CAPA remediation, or audit programs.

Short or long term contracts: QA leadership on a monthly basis. Ideal for emerging biotech and small sponsors who need senior QA expertise without the cost of a full time hire. I become your embedded quality partner.

Hourly Consulting: Flexible support for targeted questions, document reviews, or short term needs. A practical option when you need senior level input without a longer commitment.

Audits: Thorough GCP Investigator Site and Service Provider audits or monitoring quality oversight visits,

What You Can Expect From Me:

A response within one business day
Honest assessments — I will tell you what you need to hear, not just what you want to hear
Senior level attention on every engagement — you will always work directly with me
Confidentiality and discretion as a matter of professional obligation
A partner who treats your compliance challenges as seriously as you do

Ready to talk?

Reach out at lisamartin@truenorthqa.com or connect with me on LinkedIn. I am happy to start with a no obligation introductory call to explore whether we are a good fit.

Capabilities

Quality Management Programs

Inspection Readiness and GCP Audits

Risk-Based QMS Design and Implementation
Policy, SOP, and Work Instruction Authoring and Harmonization
ICH E6 R3 Implementation
Service Provider and System Qualification Activities
Quality Oversight of study or portfolio

Inspection Readiness and GCP Audits

Inspection Support (FDA, MHRA, EMA)
CAPA Management and Effectiveness Evaluation
Audits: CROs, Investigator Sites, and Service Provider Qualifications
Process and System Audits, including eTMF
Computerized Systems Validation Reviews
Assess Data Integrity

Training and Workshops

ICH E6 R3 Training
Inspection Readiness Training
Other Training
Continuous Improvement and Change Management Workshops
Process Improvement / Kaizen Event Activities
Lessons Learned

Strategic Consulting

Training and Workshops

Quality Support for Sponsors and CROs
Gap Analysis
Post-Inspection Remediation and Responses
Develop Quality Metrics and Key Performance Indicators (KPIs)
Harmonize processes across newly combined businesses

Welcome

Sound Compliance. Strong Partnerships.

Hi, I'm Lisa Martin

I am your partner in GCP compliance.

What to expect when we work together:

Capabilities

Quality Management Programs

Inspection Readiness and GCP Audits

Inspection Readiness and GCP Audits

Inspection Readiness and GCP Audits

Inspection Readiness and GCP Audits

Inspection Readiness and GCP Audits

Training and Workshops

Training and Workshops

Training and Workshops

Strategic Consulting

Training and Workshops

Training and Workshops

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