Patient safety is first! Pharmacovigilance driven by protecting patients through detecting and defining medication safety risks.
At Noss Research Consulting, the patient is always first. We take pride in providing excellent safety strategy to product development teams in clinical trials and post-marketing, always ensuring timely and high-quality execution of safety documents.
With a total of 45 years combined of clinical research and pharmaceuticals experience, we have cultivated a strong medical expertise within:
- Pre and post-marketing safety surveillance
- Safety strategy
- Execution of PV documents such as SMPs, RMPs, SAEs and PSMFs
- Medical review of SUSARs
- Management of PV service providers
- Publishing sections of protocols, ICFs, DSURs, SOPs and other safety documents
Along with our fortified medical background, we specialize in the following pharmacovigilance areas:
- PV risk assessment and management
- Key performance indicators
- FDA REMS
- SUSARs
- MedDRA
- EudraVigilance
- PV vendor management
- Medical Inquiries
- Product Quality Compliance
- IDMC and SRC
We have extensive experience in the following therapeutic areas:
- Oncology
- Rare diseases
- Cardiovascular
- Gastroenterology
- OB/GYN
- Dermatology
- Immunology
- Pulmonary
- Infectious Diseases
- Endocrinology
- Renal
- Pre-term infants
- Vaccines
- Chronic Hepatitis
- Consumer Health
Our mission is to 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.
Latest Blog Posts
Unraveling the Narrative of Adverse Drug Reactions: A Patient-Centric Journey
In the labyrinth of modern medicine, adverse drug reactions (ADRs) stand as formidable challenges, often shrouded in mystery and uncertainty. For patients, navigating the landscape of ADRs can be...
Are Machine Learning Models the Future of More Accurate and Precise Safety Signal Monitoring?
Explore the results of 4 different machine learning models and how they can change the current safety monitoring landscape.
Decades of Protection: The Enduring Legacy of the Quadrivalent HPV Vaccine
The quadrivalent human papillomavirus (qHPV) vaccine has demonstrated remarkable durability in preventing HPV-related diseases, even over a decade after administration. Long-term follow-up (LTFU)...
HER-2 Phase II Breast Cancer Study: Everything You Need to Know
Welcome to our deep dive on the ongoing breast cancer vaccine study, formally known as the "Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients With HER-2 Positive Breast...
Dengue Diffusion: “Effective Dengue Control is Going to Require Multi-Layered Efforts”
Stated plainly by Adam Waickman, an accomplished immunologist at SUNY Upstate Medical University in Syracuse, slowing the dengue virus epidemic is going to take the international collaboration of...
Pharmacovigilance Development: A Global Challenge
Pharmacovigilance is an incredibly essential component of monitoring patient safety. One of the largest responsibilities of pharmacovigilance professionals is to observe adverse drug reactions...
Is PV Conducted in All Breast Cancer Treatments?
Breast cancer has been one of the largest global threats to women's health for decades, with the American Cancer Society estimating nearly 297,790 new cases in U.S. women during 2023 alone. ...
Using Vaccines to Prevent or Mitigate the Effects of Post-Tuberculosis Lung Disease (PTLD)
While tuberculosis has been a threat to public health since the first half of the 19th century, it continues to be a public health priority that currently affects over 10 million people. In...
Flaws in Vaccine Development: Was the COVID-19 Vaccine Rolled Out Too Quickly?
Throughout the history of vaccinology and drug safety, there have been innumerable adaptations and breakthroughs within the medication and vaccination development processes. However, since the very...
Consultants highly experienced in GCP, GLP, GVP, GMP.
Routine and for-cause audits, regulatory mock inspections, SOP writing, global regulatory submissions experts and IT audits. Excellent organizational, management, leadership, and interpersonal skills. Prioritize and manage multiple assignments concurrently with exceptional attention to detail and meticulous follow-through, and highest quality.
Rebecca
Global Pharmacovigilance Consultant with 26 years of solid experience. Master of Science in Pharmacovigilance Pharmacoepidemiology. Expertise: medical assessment of SAEs and SUSARs, PV KPIs, PV CRO oversight, risk management, voting member for IDMC, safety signal reviewer, call centers, specialty pharmacies, business partners, SDEAs, literature review, and safety documents.
Joel
Former FDA Investigator that spanned for a period of 35 years. Expertise: Certified ORA BIMO Investigator, international inspections, GCP inspections of Sponsors, Clinical Investigators, CROs, IRBs, PV, drug GMP, and Non-clinical laboratories (GLPs) inspections.
Emma
Pharmacist with over 15 years of strong experience. Master of Science in Pharmacovigilance Pharmacoepidemiology. Expertise: medicine regulation, global regulatory systems, inspected over two hundred facilities for GMP, GCP, GLP. Mentor and trainer for inspectors for good practices.
Kishan
Kishan is an ardent Pharmacovigilance and Quality Assurance professional who specializes in delivering fit-for-purpose and risk-based Pharmacovigilance audits as well as mock inspections. Whether it is the development of long-term PV audit programs/universes, the conduct of PV or FDA REMS audits, or other assignments involving the refinement of Quality Management System (QMS), Kishan can help you assure your PV quality and compliance in a pragmatic manner.
Navya
Eight years of solid pharmacovigilance experience. Master of Science in Biotechnology. Expertise: ICSR processing, MedDRA coding, EudraVigilance, AE and SAE reconciliation, writing of aggregate safety reports, PV SOPs, and DSUR.
Don
Forty-two years of professional experience. Expertise: Extensive auditing experience in the conduct of Routine and Directed GCP audits, Scientific Misconduct and Pre-Qualification audits of Clinical Investigator Sites, Vendors (GLP & CROs), Sponsor systems and processes, including Clinical Monitoring, Project Management, EDC, SOP Gap Analysis, Paper and Electronic Trial Master File Systems (eTMF), CTMS, GCP, Training and Regulatory Affairs.
Business Partner Services
Jim Sanders
MPH
Jim is the president and owner of ClinOhio Research with over 20 years of clinical research experience. He has completed over 150 studies ranging from animal research to human research in phases 1-4. He earned his Bachelor of Science in Biology from the University of Southern Indiana and his Masters of Public Health from The Ohio State University. He started ClinOhio Research in 2017.