CLINICAL TRIALS

Mr. Carpenter has participated in a number of clinical trial studies both as a statistician and as a data manager.

The data base structure and statistical analyses of two large clinical trial studies aimed at FDA pre-market approval of laser surgical devices were designed and implemented. The data base management aspects of the study included a full screen data entry and verification system, as well as, an automated reporting system.

A CANDA system was designed and implemented using SAS for the Phase I and Phase II study of an asthma drug. The system included full data entry, validation, and reporting capabilities.

Statistical consultations were provided to a series of clinical studies concerning the safety and efficacy of a class of suture techniques.

Graphic presentations were developed for a study concerning several techniques designed to increase the survivability of babies born prematurely.

Mr. Carpenter has provided both statistical and data processing support to a clinical study on a pre-surgical technique used in conjunction with the removal of cataracts.

Data processing support including table design and implementation for a NDA study on monitoring heart stress.

Related experience includes extensive SAS program development and maintenance for a San Diego health care insurance company.

Several projects involved the design and implementation of software systems that would control the structure, attributes, and naming conventions of data tables with the objective of compliance with CDISC standards.