About Us
Welcome to Noss Research Consulting LLC
At Noss Research Consulting LLC, patient safety is at the center of everything we do. We understand that successful clinical development depends on trusted partnerships, scientific excellence, and unwavering regulatory compliance. That’s why we work as an extension of your team, delivering personalized, high-quality pharmacovigilance (PV) and drug safety solutions tailored to your organization’s unique needs.
From first-in-human studies through post-marketing surveillance, we provide comprehensive, innovative, and reliable pharmacovigilance support across the entire product lifecycle. Whether supporting emerging biotech companies, global pharmaceutical organizations, or investigator-initiated clinical trials, our goal is to help clients navigate an increasingly complex regulatory landscape while maintaining the highest standards of patient safety.
Our Mission
Clinical trials have the power to transform and save lives. Every safety decision has the potential to improve patient outcomes and advance medical innovation.
Our mission is to partner with pharmaceutical companies, biotechnology organizations, academic institutions, and investigator-initiated research programs to ensure that patient safety remains the highest priority throughout the clinical development lifecycle.
Through scientific rigor, regulatory expertise, and collaborative partnerships, we help our clients accelerate development while maintaining the highest standards of pharmacovigilance, patient
protection, and compliance.
At Noss Research Consulting LLC, we don’t simply support pharmacovigilance—we help build safer clinical development programs
that inspire confidence most importantly to the patients we serve, sponsors, clinical investigators, and regulators.
Services
Is Your Organization Prioritizing Patient Safety With Effective Pharmacovigilance?
Pharmacovigilance is key to identifying and managing drug-related safety risks, safeguarding patients, and ensuring the safety of medications throughout the entire lifecycle. Let us help you strengthen your safety protocols and protect your patients.
Why Noss Research Consulting?
Our team brings more than 200 years of combined global experience in clinical research, pharmacovigilance, regulatory science, and medical safety. Our consultants include highly experienced professionals with strong medical, scientific, and regulatory backgrounds who have successfully supported clinical development programs across multiple therapeutic areas and all phases of clinical research.
We understand that every sponsor has unique challenges. Rather than offering a one-size-fits-all approach, we deliver right-sized, flexible pharmacovigilance solutions designed to meet your operational, scientific, and regulatory requirements—whether you need strategic consulting, project-based support, or fully outsourced pharmacovigilance services.
Our Expertise
We provide comprehensive pharmacovigilance services, including:
- Clinical trial safety management
- SAE processing and medical review
- SUSAR assessment and expedited reporting
- Aggregate safety reporting (DSURs, PSURs/PBRERs)
- Safety Management Plans
- Safety surveillance and signal detection
- Medical monitoring support
- Pharmacovigilance quality systems and SOP development
- Regulatory inspection readiness
- Vendor oversight and governance
- Safety database consulting
- Risk management and benefit-risk evaluation
- Pharmacovigilance training and compliance
SPECIALIZATIONS
Building on our strong medical background, we specialize in the following areas of pharmacovigilance:
- EudraVigilance
- PV risk assessment, safety signal assessment and management
- Key performance indicators (KPIs)
- FDA REMS
- SUSARs
- MedDRA
- PV vendor management
- Medical inquiries
- Product quality compliance
- DSMB and SRC
THERAPEUTIC AREAS OF EXPERTISE
We have extensive experience across the following therapeutic areas, and not limited to:
- Oncology
- Rare diseases
- Cardiovascular
- Gastroenterology
- OB/GYN
- Dermatology
- Immunology
- Pulmonary
- Infectious diseases
- Endocrinology
- Renal
- Preterm infants
- Vaccines
- Chronic hepatitis
- Consumer health
- Neurology
We provide a full service pharmacovigilance experience while putting organizational integrity and patient safety at our forefront. Contact us today to learn more about our services.
PARTNERSHIPS
Cloudbyz
Cloudbyz provides a cloud-based PV database that empowers pharma, biotech, and medtech companies to accelerate safety decisions while ensuring seamless global PV compliance.
Visit Cloudbyz’s website here
ClinOhio Research Services
ClinOhio Research Services is a dedicated research site focused on women’s health, dermatology, and vaccines. Since 2017, it has been advancing medicine by providing a seamless experience for both patients and sponsors, driven by respect, compassion, and comfort.
Visit ClinOhio Research Services here
Pharmity
Pharmity provides specialized consultancy services for the health sciences industry, with a focus on clinical research. Offering tailored solutions from a team of over 25 senior consultants, Pharmity combines local expertise with global insights to address the unique challenges of each client.
Visit Pharmity’s website here
Consultants
Rebecca Noss
Owner/Founder
Rebecca Noss is the Owner and Founder of Noss Research Consulting LLC, a firm specializing in pharmacovigilance (PV) and drug safety. With over 27 years of experience in the pharmaceutical industry, she is a seasoned Global Pharmacovigilance Consultant with an M.Sc. from the Université de Bordeaux, France. Her work is dedicated to ensuring patient safety throughout the clinical trial lifecycle and post-marketing phases.
Under her leadership, Noss Research Consulting offers tailored PV solutions to clients, emphasizing collaboration and a personal touch. The firm’s team brings together decades of experience to deliver customized support across all areas of drug safety and clinical research.
Rebecca’s commitment to patient safety and her extensive expertise make her a trusted partner in the field of pharmacovigilance.
Dr. Bahrami
Dr. Bahrami obtained her MD degree from Ross University School of Medicine. Dr. Bahrami is an Internist and certified Principal Investigator with Trialmed (previously AES) for 5 1/2 years, managing clinical trials phase (I, II, III, IV). Extensive experience and not limited to oncology, neurology, cardiovascular, infectious disease, pulmonary, and GI. Prior to clinical research, she has had 10 years of clinical experience working in hospital settings and taking care of patients with a variety of pathologies.
Joel
B.S. in Biology from Baylor University, Texas. With 35 years of experience as an FDA Investigator, conducted inspections across GMP, medical devices, biologics, and certified ORA BIMO. He served as a BIMO specialist for the Dallas District Office, specializing in GCP/GLP/GVP inspections. He has worked in various therapeutic areas and not limited to oncology, immunology, neurology, cardiovascular, dermatology, and metabolism.
Emma
MSc in Pharmacovigilance and Pharmacoepidemiology from the Universitè de Bordeaux France. Experienced Pharmacist with over 15 years in regulatory affairs, specializing in dossier reviews for modules 2, 3, and 5. She has audited over 200 facilities for GMP, GCP, and GLP compliance and is well-versed in regulatory submissions across the USA, Europe, Africa, Canada, and Australia.
Kishan
Master of Science: Regulatory Affairs and Compliance for Drugs, Medical Devices and Biologics from the Northeastern University Boston and Master of Pharmacy: Pharmacology Gujarat Technological University. Certified Biomedical Auditor (ASQ), ISO 9001 Lead Auditor (BSI). Ardent pharmacovigilance and quality assurance professional with 15 years of experience. He specializes in pharmacovigilance auditing, FDA REMS audits, and risk-based audit planning. Kishan has extensive experience managing PV inspections, adverse event reporting, and preparing regulatory documents.
Navya
Master’s degree in Biotechnology, Harrisburg University of Science and Technology, Harrisburg PA. With over 10 years of experience in pharmacovigilance, maintenance of the Safety database, creates safety reports for all clinical studies, writes safety narratives, coding the adverse events and serious adverse events with MedDRA and Who-DD drug dictionary. Performs safety reporting through EudraVigilance via EV-Web, inspection readiness, management of PV mailbox, SAE reconciliation, unblinding subject information in safety database, DSUR and aggregate periodic safety reports.
Don
Bachelor of Science Journalism & Communications, University of Florida. Over 42 years’ experience in the pharmaceutical and clinical research industry. With over 42 years of experience in pharmaceutical research, expertise in all areas of GCP, vendor management, Regulatory affairs, development of quality systems, SOP writing, and overall process improvements. Extensive auditing REMS, Routine and Directed GCP audits, Scientific Misconduct and Pre-Qualification audits of Clinical Investigator Sites, Vendors (GLP & CROs), hospitals, and Sponsors.
Karrin
Master’s degree in Public Health Community Health/Preventative Medicine University of Tennessee. Pharmacovigilance professional with 15 years of experience in strategic safety planning for investigational and market products, global Adverse Event (AE) case processing and Serious Adverse Event (SAE) reporting (SUSAR and periodic reports), regulatory intelligence for clinical and post marketed products (also Device and combination), regulatory audit and inspection preparation and resolutions, development of SOPs, signal detection review, and safety data exchange agreements.
Christina
Registered nurse and Master of Medical Science in Drug Development from the University of New South Wales Australia Graduated with Distinction. 24 years in biopharma operations & leadership, driven by the pursuit of excellence for improved patient outcomes. Strong experience in Pharmacovigilance, Licensing, Medical Information (MI) & Quality Management Systems (QMS) with operational agility; blending strong functional expertise with a strategic, pragmatic, customer & patient centric approach.
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