Signa Medical Writing is a personal and dynamic medical communications company providing a comprehensive suite of downstream pharma support services necessary to expedite the final steps of the early phase clinical research process. Our services include medical writing, biostatistics, PK and PD data analysis and interpretation, quality control review of regulatory documents, electronic publishing, and regulatory affairs consultation. We are proud to work closely with strategic partners in the industry that offer clinical operations, clinical monitoring, data programming, and data management. Our clients range from large international pharma companies and clinical research organizations to small start-ups bringing their first drug to market. Specializing in early phase clinical research, our skilled and experienced employees and consultants work closely with clients and sponsors to develop regulatory compliant documents of the highest quality. Medical Writing • Clinical protocols and protocol amendments • Full and synoptic integrated clinical study reports (CSRs) and addendum documents • Safety narratives • Investigator brochures Biostatistics • Statistical methodology and results sections of protocols and CSRs • Sample size calculations • Statistical analysis plans (SAPs) and shell/mock tables, listings, and figures (TLFs) • Inferential and descriptive statistical analyses of clinical study data • Program datasets in SAS using CDSIC SDTM and ADaM standards PK and PD Data Analysis and Interpretation • Basic and complex PK study design • Pharmacokinetic methodology and results sections of protocols and CSRs • Review of SAPs and draft PK/PD datasets • Noncompartmental PK analysis using Phoenix WinNonLin Electronic Publishing • Draft and final CSR publishing per eCTD specifications • Document level publishing • Electronic appendices compilation