Rho emphasizes speed, accuracy, and reliability to help you maximize the information return on your research investment. With over 20 years of excellence in providing expert statistical analyses for all phases of drug development, Rho’s biostatisticians have extensive experience in a wide range of therapeutic areas.

Rho boasts one of the most highly educated biostatistics departments in the world. With university origins and continuing academic ties, Rho’s biostatisticians are extensively trained in advanced methods of statistical analysis. Nearly all of our biostatisticians have postgraduate degrees, many of which are at the doctoral level. Rho’s biostatisticians participate in rigorous training sessions to reinforce fundamental practices and explore methodologies of just-published methods.

Rho has been an industry leader in formulating and adopting CDISC data standards, both anticipating the future of the industry and helping speed its arrival. The company’s senior staff enjoys close working relationships and frequent dialogues with the FDA, possesses extensive regulatory experience, and holds governance roles within DIA.

Rho’s extremely low staff turnover rate ensures a high level of continuity. The biostatistician who helps design your trial will likely be the biostatistician who analyzes the data and participates in the report writing process. Rho’s biostatisticians consistently work with external teams to ensure accurate results meet Sponsor specifications.

Rho’s experts provide the full spectrum of biostatistical services for all phases of drug development, including:

Clinical Trial Planning and Design Strategic planning for clinical development Pretrial regulatory guidance and FDA liaison Protocol development, grounded in sound, advanced statistical methodology Power/sample size calculations Randomization Routine, stratified, adaptive, and interactive Rho RAND ™: 24x7 interactive voice response randomization service, with Web interface and continuous operator backup Statistical Analysis and Data Display Generation Statistical analysis plans Detailed, written statistical analysis specifications of statistics, tables, listings, and graphic displays Analysis file creation – provided by Rho’s Statistical Computing Department Sponsor customized statistical and graphical programming using either custom code or Rho TABLES ™ Expert statistical analyses – from routine t-tests to leading-edge, just-published methods Ad hoc/exploratory analyses – expert statisticians wring every bit of information from your data

Data Safety Monitoring Board (DSMB) Appoint and/or chair the DSMB Perform all analyses Convene meetings Record minutes Produce reports Serve as DSMB member to provide biostatistical expertise Reports Final study reports Integrated clinical/statistical reports Integrated Safety/Efficacy summaries IND annual updates Post-trial regulatory guidance and FDA liaison NDA – complete preparation of statistical components, assistance with entire NDA Statistical Training – public and on-site short courses on advanced statistical methods Mixed (random effects) models Generalized estimating equations (GEE) Generalized linear models (GLM) Quality of life

Our philosophy is simply to be attentive and to respond rapidly and comprehensively to requests; deliver quality results consistently, efficiently, and within budget; and offer ideas and solutions that will achieve stated goals. When you need accurate results on time, call on Rho.