Clinical Research and Development

Kelly provides full service capabilities in biometrics, data management, and clinical operations. Our team of technical and scientific experts brings the knowledge and experience necessary to assist research and development efforts within all phases:

• Pre-clinical and animal
• Phases I, II, III
• Phase IV and post-marketing
• PK/PD

Biometrics
We have experienced biostatisticians and statistical programmers supporting studies targeted toward NDA, BLA/ PLA, and MPA.

We provide:

• Statistical design and protocol development
• Statistical analysis plans (SAPs)
• Statistical reports and publication design/support
• Statistical programming (SAS®) and analysis
• Summary tables, patient listings, and graphs
• Integrated summaries of safety and efficacy (ISS/ISE)
• Sample size and randomization

Clinical data management
Our experts have significant experience in the following areas:

• CRF design and printing
• Database installs/upgrades
• Medical coding
• Data entry and validation
• Data coordination and integrity
• QC and edit checks
• Electronic data capture (EDC)
• Electronic submissions
• Oracle® Clinical and ClintrialTM

For more information, contact:

Michael Ruchman
Phone :: 858.232.7110
E-mail :: michael.ruchman@kellyservices.com

Daniel Rhodes
Phone :: 760.458.4505
E-mail :: daniel.rhodes@kellyservices.com