Innovative Clinical Research, deliver consulting services in the areas of Biostatistics, Statistical programming, FDA interactions and Regulatory interactions. At Innovative Clinical Research 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. Innovative Clinical Research 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). Innovative Clinical Research 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. Innovative Clinical Research 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