Clinical Research · Emergency Response · Life Sciences Consulting

Two Disciplines.
One Firm.

Jean Mastrangelo — Clinical Research Professional · Mark Mastrangelo — Emergency Response Educator

Wister Group LLC brings together deep clinical research expertise and certified emergency response training under one roof — delivering integrated consulting solutions for pharmaceutical, biotechnology, and life sciences organizations.

Start a Conversation Meet the Team
20+
Years Combined
2
Expert Principals
1
Unified Practice
Our Team

Meet the Principals

Wister Group LLC is built around two seasoned professionals whose complementary expertise creates a uniquely full-spectrum consulting firm for the life sciences industry.

JB
Jean Mastrangelo
Clinical Research Professional

Jean is a clinical research professional with deep expertise across the pharmaceutical and biotechnology sectors. She brings a rigorous, science-driven approach to clinical development — supporting organizations from protocol design and site management through regulatory submission and post-market surveillance. Her background spans both sponsor and CRO environments, giving her the breadth to advise clients at every stage of the drug development lifecycle. Jean's strength lies in translating complex clinical data into actionable strategy, helping her clients reach regulatory milestones with precision and confidence.

Clinical Research Pharma & Biotech Regulatory Affairs Protocol Development GCP Compliance Clinical Operations View Full Profile →
MM
Mark Mastrangelo
Emergency Response Trainer & Educator

Mark is a certified emergency response trainer and educator with extensive experience designing and delivering life-safety programs for organizations in regulated industries. He specializes in CPR, First Aid, and emergency preparedness — creating curricula that go beyond generic certification to address the specific hazards and protocols unique to pharmaceutical and industrial environments. Mark's programs are built to instill genuine confidence in the workforce, ensuring employees are not just trained on paper but truly prepared to act decisively when it matters most.

CPR Certification First Aid Training Emergency Response Safety Programs OSHA Compliance Workforce Education
Services

What We Deliver

Two distinct service tracks, each led by a dedicated principal — together representing a comprehensive consulting offering for life sciences organizations.

Jean Mastrangelo Clinical Research
Clinical Trial Management & Operations
End-to-end clinical trial support — from study start-up and site selection through monitoring, data management, and close-out — aligned with ICH-GCP and sponsor requirements.
Regulatory Strategy & Submission Support
Guidance on regulatory pathway selection, IND/NDA/BLA strategy, and submission document preparation for FDA and international health authorities.
Protocol & SOP Development
Authoring and reviewing clinical protocols, informed consent documents, and standard operating procedures to meet current regulatory standards.
GCP Compliance & Audit Readiness
Gap assessments, audit preparation, and remediation support for sponsors, CROs, and clinical sites requiring GCP compliance strengthening.
Pharmaceutical Operations Advisory
Strategic guidance for pharma and biotech organizations navigating process optimization, quality system development, and operational scale-up.
Mark Mastrangelo Emergency Response & Safety
CPR & AED Certification Training
Certified CPR, AED, and cardiac emergency response training for organizations — customized to workforce size, environment, and regulatory requirements.
First Aid Program Development & Training
Comprehensive first aid curricula tailored to pharmaceutical and industrial settings, ensuring employees can respond effectively to workplace medical emergencies.
Emergency Response Planning
Design and implementation of site-specific emergency response plans, including evacuation procedures, medical response protocols, and crisis communication frameworks.
OSHA Compliance & Safety Programs
Written safety program development, hazard assessments, recordkeeping systems, and OSHA-aligned training to support regulatory compliance and workforce protection.
Safety Culture & Workforce Education
Building durable safety cultures through instructor-led training, tabletop exercises, and ongoing education that keeps preparedness front and center.
Track Record

Professional Experience

Jean Mastrangelo — Clinical Research
Present
Principal, Clinical Research Consulting
Wister Group LLC
Leading clinical research consulting engagements for pharmaceutical and biotechnology clients — providing strategic and operational guidance across the clinical development continuum.
Career
Clinical Research Professional
Pharmaceutical & Biotech Industry
Progressive experience within sponsor and CRO environments — spanning clinical operations, regulatory affairs, study management, and compliance in FDA-regulated settings.
Core Expertise
Clinical & Regulatory Competencies
FDA · ICH-GCP · IND/NDA/BLA
Clinical trial management · GCP compliance · Regulatory submissions · Protocol authoring · Informed consent · Site monitoring · Data integrity · Audit readiness.
Mark Mastrangelo — Emergency Response
Present
Principal, Emergency Response & Training
Wister Group LLC
Designing and delivering certified emergency response and safety training programs for pharmaceutical, industrial, and community organizations across regulated environments.
Career
Certified Emergency Response Trainer
Multi-Industry Experience
An extensive career in emergency response education — developing instructor-led programs, training curricula, and safety systems for organizations of varying size and complexity.
Core Expertise
Safety & Emergency Competencies
OSHA · CPR/AED · First Aid · ERP
CPR/AED certification · First aid training · Emergency response plans · OSHA compliance · Hazard assessments · Written safety programs · Crisis preparedness · Workforce education.
Qualifications

Combined Expertise

🧬
Jean Mastrangelo
Clinical Research
Pharmaceutical & biotech clinical development from IND through post-market
📋
Jean Mastrangelo
GCP & Regulatory
FDA submissions, GCP compliance, audit readiness, and regulatory strategy
❤️
Mark Mastrangelo
CPR & First Aid
Certified CPR/AED and first aid training tailored to regulated workplaces
🛡️
Mark Mastrangelo
Emergency Response
OSHA compliance, emergency response planning, and safety program design
Focus Areas

Industries We Serve

Wister Group LLC brings specialized expertise across the life sciences value chain — from early-stage biotech to established pharmaceutical manufacturers and the broader healthcare ecosystem.

Pharmaceutical Manufacturing Biotechnology Clinical Research Orgs Medical Devices Specialty Pharma Biologics CDMO Life Sciences Healthcare Organizations Corporate & Industrial
2
Senior-Level Principals, Every Engagement You work directly with Jean or Mark — not junior staff. Every project is led by a subject-matter expert from day one.
20+
Years of Combined Industry Experience Jean and Mark together bring decades of hands-on expertise across clinical research and emergency response in regulated environments.
100%
Tailored Engagements No off-the-shelf solutions. Every consulting engagement and training program is customized to your organization's specific needs and goals.
1
Uniquely Integrated Firm The only firm offering combined clinical research consulting and emergency response training under a single trusted partnership — built for life sciences.
"

The training program provided by Wister Group LLC was top-notch. Our employees are now better prepared for any emergency situation.

Donna Hoder — Local Community Group
Contact

Let's Work Together

Whether you need clinical research expertise, certified safety training, or both — Wister Group LLC is ready to partner with your organization. Reach out to start the conversation with Jean or Mark directly.

🌐
wistergroupllc.com
💼
linkedin.com/in/jbmastrangelo
📧
jmastrangelo@wistergroupllc.com
📞
267-888-7498