We provide statistical expertise in assessing the safety, efficacy, effectiveness, quality, and consumer perception of consumer health products, as well as informing evidence-based decision-making, regulatory compliance, and product development strategies.
Consumer Health
Our Approach
Drawing on our extensive experience, we excel in identifying the most efficient and cost-effective approaches to ensure commercial success. Embracing a philosophy rooted in vast knowledge and expertise, we support each client, irrespective of size or scope, guaranteeing every assignment receives the same level of dedication, ownership, and cohesion for successful study outcomes.
Consulting
Our consulting services encompass a range of offerings, including interaction guidance with the FDA, ICH, and EMA, in addition to insightful advice on CDISC integration, professional SOP writing, targeted training courses, strategic process improvement, and on-site statistical support.
Design
From sample size calculations and randomization to clinical investigation plan development and study planning, we excel in crafting robust Statistical Analysis Plans (SAPs) and presenting study designs to regulatory agencies based on the product’s characteristics.
Analysis
Our expertise extends to final or interim analyses, blind data review meetings, inferential analyses, pharmacokinetics services, and the generation of summary tables, listings, and figures. We’re adept at CDISC standards and ensuring timely updates of historical study data to these standards.
Reporting
Compliance is at the forefront of our services, delivering ICHE3-compliant statistical reports and Clinical Study Reports (CSRs). Our support extends to publications arising from study results, crafting integrated summaries, and preparing regulatory dossiers for NDA/PMA submissions.