Bio Statistics

❖Use statistical software packages to propose clinical study designs  with the appropriate sample size and power calculation.
❖ Develop and write prespecified statistical analysis plans.
❖ Generation of Randomization Schedule.
❖ Pk and Statistical analysis for Bio-equivalence studies/Clinical Trials.
❖Bootstrap analysis to see the success rate and to find the % CV, sample size basis on pilot PK data.
❖ F2 analysis of In vitro or In vivo data.

CDISC SOLUTION

❖ Clinical Data Interchange Standards Consortium (CDISC) devised the SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) models to standardize data structures for submission of raw and analysis data from clinical trials. These standard formats are increasingly expected by regulatory authorities including the USFDA.

❖ SDTM is the submission data standard into which raw study data are mapped and collated. ADaM is a companion standard for use with analysis data and it is best practice to use SDTM data as the source for these datasets. Doing this allows for the easy documentation of any data processing with Define-XML, the CDISC standard for data definition files.

We have a team of experts catering CDISC dataset solution mandatory for US Submission

IVIVC-IVIVR ANALYSIS

❖  In vitro–in vivo correlation (IVIVC) is a predictive mathematical model describing the relationship between an in vitro property and a relevant in vivo response. The main objective of an IVIVC is to serve as a surrogate for human bioequivalence (BE) studies, which may reduce the number of BE studies performed during the initial approval process as well as with certain scale-up and post approval changes.

❖  A IVIVC-IVIVR analysis can be useful during development phase for going to Pilot BE and also can be useful to predict  outcome before going for Pivotal BE study. The analysis can be helpful to decide on best batch out of 3 PV/EB batches to go with for Pivotal BE study.

❖ Our subject matter experts can help client to finalize the formulation strategy based on IVIVC. 

We have a team of statisticians with expertise & Knowledge of different regulatory agencies