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
Tedopi®: First Cancer Vaccine Shows Strong Efficacy
Tedopi® is a novel T-cell epitope-based cancer vaccine targeting five tumor-associated antigens, aimed at expanding tumor-specific T-lymphocytes in HLA-A2 cancer patients. As an off-the-shelf...
Safety on the Forefront with Blood Cancer Treatment
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA), a clinical-stage biotechnology company dedicated to developing innovative immunotherapies for cancer, has announced updated efficacy and safety...
Understanding the Role of Selinexor in Treating Recurrent Glioblastoma: A Drug Safety Perspective
Glioblastoma (GBM) is the most common primary brain tumor in adults and is associated with a poor prognosis. The karyopherin exportin-1 (XPO1) is a nuclear export protein that plays a critical role...
Strengthening Critical Medicines
Decoding the MSSG’s New Recommendations The European Medicines Agency's Medicines Shortages Steering Group (MSSG) has developed recommendations to ensure the availability and supply of...
REMS Requirements & How They Are Received by Patients and Caregivers
A qualitative study involving 63 participants examined their experiences with REMS (Risk Evaluation and Mitigation Strategies) programs associated with four specific drugs: Natalizumab,...
Chikungunya: What is it and Who Should Get Vaccinated?
What is Chikungunya (CHIKV)? Chikungunya Virus, also known as CHIKV, is a mosquito-borne viral disease that has been reported in over 110 countries. The name comes from the African Kimakonde...
Exploring COVID-19 Vaccine Effectiveness & Safety: Insights from Recent Studies
As the fight against COVID-19 continues, the efficacy and safety of vaccines remain critical considerations. Recent studies shed light on both fronts, offering valuable insights into vaccine...
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)...
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.
Robert
Twenty-one years of professional experience. Expertise: GCP audits of vendors and clinical sites, SOP writer. He was the global lead for the Moderna Pediatric Vaccine, which was fast-tracked to approval.
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.