Tech Observer's statistical services are composed of experienced Ph.D. and M.S. level of Statisticians/ Biostatisticians, SAS Certified (Base and Advanced) Programmers. Our efficient, experienced and skilled staff is expert in the design and analysis of Phase I–IV clinical trials with varying designs, such as parallel group, cross-over, Bayesian designs, pharmacokinetic/ pharmacodynamic evaluations, therapeutic equivalence testing, and sequential designs. Tech Observer's Statisticians are highly skilled in every aspect of experimental design and are also able to determine study objectives and develop Statistical Analysis Plans (SAPs).
Protocol Review and Development
Study design and analysis planning
Statistical Analysis Plan (SAP)
Central randomization (paper or electronic)
ISS & ISE preparation and DSMB support
Table & Listing validation and Quality Control
Complete final analyses (Phase I–IV)
Interim & meta-analyses
Ad-hoc and exploratory statistical analyses
Statistical consulting

Table, Listings and Figures Programming
Analysis Dataset Programming and Documentation
Patient Profiles & Ad-hoc reports
CDISC (SDTM & ADaM) mapping
CRF Annotation
Regulatory E-Sub Deliverables-Preparation and QC
