Bio-Statistics & Programming:
Star Clinical Services is a trusted service provider with a primary focus on extending biostatistical programming services to the client in the entire clinical development cycle. Our team with active research has acquired enough experience in all phases of drug research and development from preclinical to clinical and post-marketing surveillance analysis suppport across a wide range of therapeutic areas.
Star Clinical Services employs handpicked professionals from our talented pool to bestow all-round support from protocol design through to study level sample calculations, analysis of tables, listing and figures.
Our dedicated team holds far-reaching experience in Biostatistics and Statistical Programming, which is suitable for pharmaceutical organizations in terms of knowledge of domains, timely delivery of outputs.
Our services include:
- Statistical input to protocol / study design development.
- Sample size calculation, Statistical inputs in Protocol & SAP development.
- Randomization Schedule.
- Review of CRF and Data Management Plan.
- Statistical Analysis Plan (SAP) and Mock-up Shells.
- Analysis of safety, Efficacy Data for CSR and regulatory submissions.
- SAS Programming - SDTM / Adam Datasets and Tables, Listing, Figures.
- Design and Deployment of System-level SAS Macros.
- PK/PD Analysis.
- Integrated Saftey and Efficacy Analysis (ISS/ISE).
- Analysis of BA/BE Studies, Meta-Analysis.
- Statistical Report Writing.
- F2 Bootstrapping for Pk data.
- Dose proportionality calculation for Pk data.
Bioavailability and Bioequivalence for Nasal Aerosols and Nasal Sprays
- Single Actuation Content (SAC) Through Container Life
- Droplet Size Distribution by Laser Diffraction
- Drug in Small Particles/Droplets by Cascade Impactor
- Particle/Droplet Size Distribution by Cascade Impactor
- Spray Pattern
- Plume Geometry
- Priming and Repriming
