Biostatistics Services

CRC Pharma’s biostatistics and statistical programming team provides world-class, regulatory compliant and integrated solutions, through our relevant expertise of programming and extensive experience of statistics. A right analysis of the right data, using right methods leads to right conclusions for any clinical study which would have translational impact on getting safe medicines to the public. Hence, we believe in providing scientific and rational solutions through operational support as well as strategic advice. We have capabilities to extrapolate our resources to meet the peak demands and provide dedicated teams. Our experts work with science driven and passionate clients in a team based fashion to provide applicable and reliable solutions. We work with them to determine appropriate methods for collecting, analyzing and presenting data while maintaining high compliance with regulatory guidelines and current practices in the industry. Our expertise spans across the translational spectrum ranging from preclinical to early and late phase clinical development.

Our programmers create study specific, need based, customized outputs with their adaptability to accustom to the clients specific requirements. We achieve this systematic statistical data analysis with careful, factual planning considering all the potential fluctuations in the real life scenario. Our team members are intricately involved throughout the lifespan of a project.

We provide following services:

Complete bio statistical services that include producing statistical analysis plans, performing statistical analysis, generating tables, listings and figures for the following types of drug research and development activities:

Non-clinical and Clinical Trial Design

  • Power and sample size calculations
  • Statistical review of protocol and CRF
  • Statistical sections of the protocol
  • Statistical analysis plans
  • Study output production
  • Production of statistical report

Clinical study randomization support

  • Production of randomization schedule
  • Act as an Independent Randomization Center (IRC)

Analysis, Reporting, and Publications

  • ISS/ISE Planning (clinical modules), analyses and electronic submission
  • Patient profiles and ad-hoc reports
  • Statistical Reports (CSR, Manuscripts, IB)
  • Development of CDISC compliant datasets
  • TLF creation, In-text table and appendix

DMC (Data Monitoring Committee)

  • Oversight of all aspects of development of IDMC (Independent Data Monitoring Committee) charters and statistical analysis plans
  • Data analysis and preparation of IDMC reports, including safety analysis and interim efficacy results
  • Presentation of analysis results by statisticians, who are voting or non-voting IDMC members
  • Provision of support for the coordination and execution of IDMC meetings, including maintaining meeting minutes of open and closed sessions