Product/Service

Biostatistical Services

Source: SynteractHCR

SynteractHCR

Delivering high-quality and accurate data analysis, SynteractHCR is a contract research organization that provides robust and customized biostatistical services tailored to your study’s needs. At SynteractHCR, we believe that a statistician is a vital component in the clinical development process. Working as your partner, SynteractHCR’s expert biostatisticians will review your study’s needs and determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our team is trained to provide creative thinking and analysis optimized for your unique study designs. We provide access to your data in a format well-suited to your project requirements.

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SynteractHCR Biostatistics Experience is Comprehensive and Knowledgeable

Since its inception, SynteractHCR has contributed to marketing applications and regulatory submissions. We have provided comprehensive biostatistics for clinical trials for over two decades. Our processes and experience have evolved and adapted quickly along with the rapidly changing regulation landscape. Our Biostatistics Group is staffed with statisticians and clinical programmers who are well versed in industry regulations and standards (21 CFR Part 11, eCTD, CDISC) and who keep current with guidance updates and developments as they pertain to CDER and CBER.

Statistical Services Include:

  • Assistance with study design and sample size determination
  • Development of statistical analysis plans, including group sequential and adaptive designs
  • Randomization schedules
  • Programming of tables, listings and figures
  • Statistical analysis 
  • Establishment and coordination of data monitoring committees
  • Complex data integration and data conversion for integrated reporting (eg., ISS/ISE)
  • CDISC format and conversion of legacy data
  • DMC Management

While providing biostatistics for clinical trials, SynteractHCR is able to provide “out of the box” thinking and analysis that will improve your clinical study design and output with responsiveness that is unmatched in the industry. Work with SynteractHCR to ensure the best statistical services for your trial.

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