{ Biostatistics }
Concise, accurate reporting begins with development of clear protocols and user-friendly case report forms. In the planning stages, the DCR biostatistics team helps develop the sample size rationale and statistical power, detailed descriptions of statistical methodology, and shells for all planned tables, listings, and figures.
Approaching each trial with this step-by-step methodology ensures succinct, accurate reporting that is International Conference on Harmonization (ICH) compliant with the production of tables, listings, and figures that are audit-ready at delivery. Our biostatisticians are also current with industry standards such as Clinical Data Interchange Standards Consortium (CDISC) models for consistent reporting to clients and regulatory authorities.
Upon completion of a trial, the biostatistics team works with the Medical Communication team and clinical scientists to ensure appropriate interpretation of quantitative results for manuscripts and abstracts, in addition to final reports for submission to regulatory agencies.
