Providing Clinical Analysis and Process Improvement
Clinical Trials Analysis
Our bioclinical consulting services tap into a wealth of knowledge gained from industry over a lengthy career in clinical quality analysis across several therapeutic areas. Depending on the project details, we may also consult on projects aimed at improving both clinical best practices.
wealth of knowledge gained from industry
Clinical Trials Consulting
Our clinical trials consulting services can support the clinical trial at most any stage: from feasibility, to start-up, to closeout and documentation. We have expertise in pilot, Phase I-III, and Phase IV (post-market surveillance) studies in the pharmaceutical industry.
experience working on clinical trial analysis
Key Clinical Performanace and Risk Indicators
Our consultants have over a decade of experience in international ICH-GCP guidelines, US Title 21 Code of Federal Regulations (as they relate to the US Food, Drugs and Cosmetics Act), and Health Canada Part C Division 5 ministry guidance (as it relates to the federal Food and Drugs Regulations).
Visual Data Analysis and Process Improvement
Our consultants have expertise in the implementation of clinical process improvement in clinical research settings, including writing and validating Standard Operating Procedure(SOP)s, performing root-cause analysis, in addition to writing and implementing Corrective And Preventative Action (CAPA) plans. This expertise is coupled with a focus on Lean / Six-Sigma principles for clinical process improvement.
