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Pharmacovigilance is an incredibly essential component of monitoring patient safety. One of the largest responsibilities of pharmacovigilance professionals is to observe adverse drug reactions...
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. ...
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...
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.
Global Pharmacovigilance Consultant with 25 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.
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.
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.
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.
Ten years of professional experience. Master of Science in Pharmacovigilance Pharmacoepidemiology from the University of Bordeaux. Expertise: GVP/GCP/GMP/GLP, Collection/Management and submission of suspected ADRs, Signal detection, Benefit-risk assessment of treatments (NNTH/NNTB, Q-TWIST, INHB, Conjoint analysis, MCDA, BRAT), PV author of RMPs, PSUR & DSUR, Insurance of compliance to applicable drugs Regulatory Authorities, monitoring Medical & scientific literature, Critical appraisal of clinical trials & studies, MedDRA coding, WHO-ART coding. Management of PV CAPAs, Change control, Complaints, Deviations & Investigations, Chemical analysis, and Management of Master Data for laboratory software.
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.
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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.