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Clinical Biostatistics and Statistical Programming

Rho has a history rich with clinical biostatistics and statistical programming excellence

We have proudly delivered expert clinical trial statistical analyses and programming to all phases of drug development in a wide range of therapeutic areas for over 30 years. In that time, our biostatisticians and SAS® programmers have built a reputation of excellence by being responsive and collaborative, producing quality deliverables, and maintaining the highest level of scientific integrity.

Few clinical trial biostatistics departments have the credentials and experience of Rho

Rho has one of the most highly educated biostatistics departments in the world. With university origins and continuing academic ties, Rho's clinical biostatistics team continually participates in rigorous training sessions to reinforce fundamental practices and explore cutting-edge methodologies.

The company's senior statistical scientists enjoy close working relationships and frequent dialogues with the FDA, possess extensive regulatory experience, and have held governance roles within the Drug Information Association (DIA)American Statistical Association (ASA), and Society for Clinical Trials (SCT).

Clinical Statistical Programming provides excellence in service and efficiency

For any phase of drug development, Rho’s biostatisticians in collaboration with our statistical programmers offer comprehensive services including:
 

  • Design of clinical trials and product programs
  • Data analysis planning
    • Protocol development
    • Statistical analysis plans (SAP)
    • Integrated summary of safety (ISS)
    • Integrated summary of efficacy (ISE)
    • Data and display specifications
  • Design and implementation of randomization systems including adaptive randomization systems
  • Data analysis
    • Planned analyses including designing analysis data sets, statistics, and displays
    • Interim analysis for adaptive designs and data and safety monitoring boards (DSMBs)
    • Exploratory analyses for publications, abstracts, and marketing
    • Non-clinical trial data from epidemiologic studies and pre-clinical studies
    • Mechanistic data
  • Generation of efficient data display using Tables Listings Figures (TLF) library
    • Tailored to client's standards
    • Double-independent validation
  • Support of data and safety monitoring boards (DSMB)
  • Specialized statistical consultation
  • Customized statistical training
    • Introduction to statistics
    • Statistics in oncology
    • Missing data methods
    • Adaptive designs

Rho's experienced professional programmers work closely with biostatisticians in the creation and validation of analysis data sets and data displays. The statistical programming team is committed to excellence in the delivery of customized, fully validated deliverables. Rho's Statistical Programmers bring education, experience, technical knowledge, and training to each project.

 

Download our FSP datasheet

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