BioScien

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STATISTICAL ANALYSIS SYSTEM (SAS)

Statistical Analysis System (SAS)

BioScien, deliver consulting services in the areas of Biostatistics, Statistical programming, FDA interactions and Regulatory interactions. At BioScien we have an experienced and dedicated team of developers with detailed knowledge of all phases across the drug development spectrum. We assure customized, fully validated deliverables by working closely with biostatisticians to build and deploy your trial. BioScien provides clinical data mapping and data conversion services whereby legacy data is mapped to new data standards ensuring compliance with changing standards.

Migrate legacy database to Study Data Tabulation Model (SDTM) standards and Analysis dataset model (ADaM). BioScien has highly active, ushered Statistical programmers with expertise to migrate legacy database to Study Data Tabulation Model (SDTM) standards and Analysis dataset model (ADaM) in compliance with FDA and CDISC requirements with ensured quality. Our team is always updated with the latest versions of Guidelines published by CDISC.

We engage in preparing study designs and research protocols for pharmacokinetic studies along with evaluation and generation of pharmacokinetic parameters. BioScien offers all phases and PK/PD analysis, Statistics and Clinical Reporting capabilities

  • Use of standard SAS macros for Non-Compartmental Analysis or Compartmental Analysis
  • Use of R and MS Excel for population PK/PD, modelling and simulation analysis
  • Reporting of all analysis in accordance with guidelines
  • Regulatory-compliant PK/PD data management

Standardized Statistical toolbox for biomarker analysis using trial data. These tools will be used to assess the quality of biomarker data, identify the potential error measurement of biomarker value, reveal the correlation among different biomarker variables, investigate the association between biomarker and clinical outcomes (such as response rate, survival duration, adverse event etc).

BioScien offers expert consulting services on complex statistical issues encountered during study design or analysis. We provide guidance in incorporating and analysing the effectiveness of statistical methodologies in clinical trials with a great deal of expertise in adaptive designs and Bayesian analysis. Our biostatisticians possess the experience and critical thinking to assist clients. We are well versed with CDISC data standards and electronic submission standards to deliver high quality, dependable analyses.

Interim assessments during the course of the study.

Interim analysis is performed to assess quality of the data collected, or treatment effects during the course of the study. BioScien Statistician’s has the expertise to understand the requirements of the study, development of interim analysis plan and designing relevant outputs.

Identify the primary and secondary study endpoints.

We engage in the planning stage of a clinical trial itself to identify endpoints, formulate testable hypothesis and to confirm the parameters of interest.

Study Objectives, Expected Outcomes, Sample Size and more.

BioScien biostatisticians have a great deal of experience in writing the study objective, the assumptions regarding the expected outcomes, the sample size required and the specific statistical techniques that will be used to evaluate the results are included.