Clinical Trial Analysis Methods
SWOB focuses on insuring the data collected from each clinical trial is complete and addresses efficiently all the objectives of the trial. In addition, accuracy of the data analyzed can be improved by review of the Data Entry and Data Management processes; optimal methods can be specified in the Statistical Analysis Plan (SAP); and timely deliverables can be produced by efficiently managed SAS programming. SWOB can provide all of these services.
Oversight of Statistical Work
SWOB’s Principal Statistician, El Giefer, has over 30 years experience mentoring other statisticians and SAS programmers in the production of successful regulatory deliverables. Interpersonal skills, as well as maintaining his own hands-on technical abilities have made this possible.
Review and Final Signoff of CRO Work
SWOB has the management, technical skills, and experience to be the final reviewer of statistical work, before FDA submission. SWOB also serves to defend and discuss with FDA statisticians the results and methods used.