Outcomes Analytics

Communication of statistical results requires consideration of the target stakeholder audience (eg, patient, clinical, regulatory, or payer) and a communication and messaging strategy. COS provides a depth of experience in statistical communications for local and global stakeholder groups and strictly adheres to regulatory guidance’s to ensure efficiencies for each report; whether full text, brief technical, or presentation-ready with interactive statistical graphics.

We know that the key to a successful COA measurement strategy goes beyond identifying, modifying or adapting a measure to use.

COS has extensive expertise in the design and implementation of prospective quantitative research studies specifically focused on the collection of COAs to address key research questions. Statistical and psychometric methods are articulated a priori and the sample is powered to ensure statistical inference in evaluable.

COS generates bespoke analytic strategies for individual psychometric and statistical research studies with the intent of positioning the most current methodologies in the analysis plan. COS prespecifies each analysis in the form of a statistical analysis plan, psychometric analysis plan, or mixed methods analysis plan complete with full mock tables, listings, and figures and strictly follows regulatory CDISC standards for statistical programming and validation. In this capacity, COS is qualified to execute analyses on clinical trial analyses, post-hoc analyses, and prospective study analysis.

COS has extended offerings to support Biostatistics teams in the development and execution of the clinical SAP. Tables, listings, and figures are developed by the internal COS team and submitted, alongside the data transfer files, programs, and main Clinical Study Report, to local and global regulators.

COS has worked extensively with Sponsors to support HTA submissions with direct experience in the submission of statistical evidence using data collected within the clinical program (Phase 3 clinical trials) in the UK, France, England, and Germany.