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Biostatistics

Pharmaceutical, biotechnology, and medical device companies are increasingly concerned about the complexity of clinical trials, the quality of trial data, competition in product commercialization, and the rapid pace of technological change. HCL can be an indispensable partner to these companies, no matter where they’re located, offering a complete set of solutions in biostatistics and SAS programming that provide support through all stages of a study.

Key Differentiators

  • A team of biostatisticians and SAS programmers with expertise in the clinical trial process

  • Comprehensive, end-to-end support, including pre-trial analysis, mid-trial reports and statistical summaries, and post-trial analysis of results and reporting to regulatory authorities following global standard operating procedures

  • Multi-stage procedural and scientific QC process, which involves a periodic review of programming standards

  • Flexibility in accommodating changes and keeping to expected timelines

  • Compliance to ICH GCP and local regulations

  • High-quality inputs and solutions in biostatistics with aggressive timelines

  • Expertise in new technologies in study design and statistical analysis

  • CDISC domain knowledge

  • Experience in statistical computing environments (SCE) and SAS platforms 

Business Value to Customers

  • Delivery of high-quality outputs within stringent timelines

  • Accurate and quick statistical planning and analysis

  • Enhanced data traceability

Services Offered

  • Protocol development, including sample size and power calculations

  • Randomization schedules

  • Statistical analysis plans (SAP)

  • Clinical and statistical SAS® programming (generating tables, listings, and figures programming)

  • CDISC® study data tabulation model (SDTM) mapping and conversion, generation of ADaM (analysis of data models)

  • Analysis dataset programming and documentation

  • Interim analysis for early decision making

  • Tables, listings, validation of figures, and quality control

  • Integrated summary of safety (ISS) and efficacy (ISE) summaries

  • Ad hoc statistical support

  • Meta-analysis – advice from expert statisticians on potential for bias during a meta-analysis as well as on statistical methods to use

  • Statistical representative at FDA pre- and post-submission meetings

  • Interpretation and reporting of biostatistics data for clinical trial reports and publications

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