Statistics

The statistician is an integral part of our clients’ project team and is involved in all key stages of their clinical trials. We provide full service statistical support including study design, statistical methodology and analysis planning, randomization, interim analysis and data monitoring committee support, generation of high quality statistical results and outputs, interpretation of findings, and regulatory and advisory meeting support. All deliverables are reviewed and verified to ensure the highest quality prior to issue and are structured to meet the varying needs of our clients. SAS is used for reporting and analysis and WinNonlin for pharmacokinetic parameter estimation. Our extensive experience includes most therapeutic areas and all clinical phases.


Medical Writing

Using our experience from all clinical phases and a wide variety of therapeutic areas, Chiltern Medical Writing staff work closely with their statistical and clinical colleagues to write protocols, Clinical Study Reports (CSRs) and publications. Prior to issue, stringent QC and proofreading procedures are applied to ensure the highest quality deliverables ready for client review. Chiltern has experience using client CSR templates as well as our own CSR template (compliant with eCTD guidelines) should clients prefer. CSRs can be provided as hyperlinked and bookmarked PDF on request. Chiltern has experience with ICH E3, E6, E9, ICH M2, and eCTD guidelines.