Rho, Inc' An Overview Asila Calhoun, Karen Wade, Tracy Nolen

1
Rho, Inc.An OverviewAsila Calhoun, Karen Wade,
Tracy Nolen
2
What is Rho?

• CRO (Contract Research Organization)
• Offers full range of clinical development
  services including
• Data Management
• Clinical Operations
• Medical Writing
• Software Development
• Biostatistics and Statistical Programming

3
Divisions of Rho

• Rho, Inc.
• Contractor to commercial clients in the
  biotechnology and pharmaceutical industries
• Rho Federal Systems Division, Inc.
• Provides support for NIH studies
• Some research areas include
• Asthma
• Hematologic and Genetic Disorders
• Autoimmune and Infectious Diseases

4
Brief Overview of Clinical Trials
Phase 2 -Initial assessment of therapeutic
effects -Explore toxic effects
Phase 4 -Post marketing observational study
Phase 1 -Determine safe dose -Develop dosing
schedule -Investigate PK
Phase 3 -Large clinical trial for new drug
applications - Formal tests (typically of
efficacy endpoint)
5
Biostatistician Responsibilities

• Study Design
• Power and sample size calculations
• Determine randomization scheme
• Collaborate with investigators to create protocol
• Support in construction of case report forms
• Write statistical analysis plans and dataset and
  display specifications

6
Biostatistician Responsibilities

• Study Analysis
• Create reports for data and safety monitoring
  while study in progress
• Conduct statistical analyses
• Program graphical displays
• Validate analyses and displays
• Write final study report
• Collaborate on manuscripts

7
Why Rho is Unique

• Wide Variety of Studies to Work on
• Epidemiology vs. Clinical Trials
• Federal vs. Commercial
• Phase I Phase IV
• Different Areas of Specialization
• Statistical Theory
• Pharmacokinetics
• Programming
• Project Management
• Software Development

8
Helpful Courses

• Everything!

• Especially
• Introduction to Clinical Trials
• Categorical Data Analysis
• Survival Analysis
• Non-parametric Analysis
• Linear Models
• Mixed Models
• General Linear Models

9
Helpful SAS Skills

• Data Management
• SAS Graph
• Macros
• IML
• ODS

10
Want More Information?

• Visit www.RhoWorld.com
• Contact
• Asila Calhoun
• Human Resources Manager
• Asila_Calhoun_at_rhoworld.com
• Karen Wade
• Senior Biostatistician
• Karen_Wade_at_rhoworld.com
• Tracy Nolen
• Biostatistician
• Tracy_Nolen_at_rhoworld.com