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.

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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

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

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

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

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

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

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

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. 

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