A small CRO (several projects on going for 3+ years)

• Developed an automated data discrepancy management and reporting system to insure data quality
• Developed semi-automated processes to create and validate data transfers
• Developed customized clinical data management reports
• Generated tables and listings

Medtronic, Inc. (1 month project)

• Developed processes to directly access Oracle clinical data from SAS
• Validated listings and summary tables in Abdominal Aortic Aneurysm Stent Graft clinical trial submission.

Synarc, Inc. (several projects over a period of 2 1/2 years)

Synarc is a medium sized organization providing radiological services to Biotech and Pharmaceutical companies in all phases of clinical trials.

• Installed and set up the SAS System (version 8.2) and Version 9.1.3) in a Linux environment.
• Set up connectivity to Clinical Data Warehouse maintained in Sybase and Oracle.
• Installed and configured SAS/Intrnet software to deliver reports via Intranet.
• Migrated data management software from Windows to Linux and from version 8 to Version 9
• Automated data management and data transfer processes using SAS macro language

Scios (acquired by Johnson and Johnson) was conducting Phase II trials for treatment of arthritis. They were also conducting numerous trials related to Natrecor, which has been approved by FDA for treatment of congestive heart failure.

• Modified existing SAS programs to read lab data (flat files and SAS datasets) from CROs and contract laboratories
• Mapped data into company standard test categories as defined in the protocol
• Modified existing software to create listings and summary tables
• Wrote new SAS/Graph programs to create graphs
• Created a master plan to migrate clinical infrastructure from Alpha VMS to Windows 2000
• Wrote custom software to export and import SAS datasets
• Developed automated processes using Reflection software and SAS software to carry out migration
• Advised them on hardware sizing, software selection and network configuration

Roche Biosciences (division of F. Hoffman-La Roche Ltd.) primarily conducts Phase I trials.

• Worked on studies pertaining to arthritis, emphysema and osteoporosis.
• Modified existing programs (ISS) to create listings, summary tables and charts
• Wrote new SAS programs to create listings, summary tables and graphs for Laboratory data (serum and urine analysis) and Vital Signs
• Wrote new SAS programs to create adverse event reports and graphs based on design provided by Clinical Monitors and Statisticians
• Developed utility macros to facilitate use of Proc Report instead of Data Null for reporting
• Used SAS Macro to automatically generate graphs as new dosage groups were added to the study
• Worked with Principal Statistician to design reports and display summary statistics
• Wrote VBScript and VBA programs to convert SAS/Graph output to PowerPoint and SAS Procedure output to Word documents
• Used Brio and SAS/Access on Windows to resolve data quality issues between Oracle Clinical database and CRfs
• Studied protocol, analysis plan and correspondence between Clinical Monitors and Study sites.
• Extensively studied CRF layout in relation to data structure of tables in Oracle
• Set up procedures to run SAS jobs in batch and monitor progress on a daily basis using DCL
• Worked on many system issues including use of XWindows on VMS, set up of graphic device drivers in SAS, SAS/Access Oracle connectivity via ODBC, SAS/Connect to VMS.

OTN (Oncology Therapeutics Network) (2 month project)

OTN (acquired by Bristol Myers Squibb), is a leading supplier of drugs to Oncology practices using Lynx machines. They receive requests from various drug manufacturers to provide reports on dosing regimens of their drugs at these practices. Amgen was interested in studying the dosing regimens of Neupogen, which is administered after chemotherapy treatments to increase white blood cells counts.

• Installed and configured various SAS products on Windows NT server including SAS/Access to Oracle and SAS Enterprise Guide
• Provided overview of SAS technology to non SAS programmers
• Converted PL/SQL based processing to SAS based processing
• Studied Oracle database schema and developed program to logic to study dosing regimens for eligible patients and practices
• Developed SAS programs to summarize dosage and create reports to be submitted to drug companies
• Replaced Excel, VB and VBA based processing with SAS/Graph to create graphs

Neurex (acquired by Elan Pharmaceuticals) was a late-stage Biopharmaceutical Company focused on products for pain management and the treatment of cardiorenal and neurological diseases. Study was for a fast acting anti-hypertension drug that controls blood pressure. Company was responding to urgent FDA request and needed to immediately submit several graphs for each patient. FDA approved the drug in September 1997.

• Replaced Excel based processing with Windows SAS macro based processing so that all graphs (numbering about 200) could be generated in batch mode.
• Wrote programs to import data into SAS and merge vitals signs data with PK data
• Using SAS/Graph created pharmacokinetic graphs showing vital signs (Systolic Blood Pressure, Diastolic Blood Pressure and Heart Rate) versus Fenoldapam plasma concentration levels at various elapsed times (pre-dose, dose and post-dose).
• Designed graphics layout to fit multiple graphs on one page to make it readily viewable.

Aradigm is a pioneer in pulmonary drug delivery and was developing insulin pump to administer insulin via aerosol medium. Conducted statistical analysis of clinical trial data of DCCT Diabetes Controls and Complications Trials. DCCT is a clinical study conducted from 1983 to 1993 by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

The largest, most comprehensive diabetes study ever conducted, the DCCT involved 1,441 volunteers with type I diabetes in 29 medical centers in the United States and Canada. Multi-centered, randomized, double blinded study. The study compared the effects of two treatment regimens--standard therapy and intensive control--on the complications of diabetes. Company wanted to use this clinical trial data to compare dosing quantities of their aerosol-administered insulin with insulin doses in the study.

• Procured study data on tape and converted it into Windows SAS
• Studied CRFs in relation to SAS Datasets, identified variables of interest and created a data dictionary
• Extracted appropriate records and variables from numerous SAS Datasets merged and transposed data as necessary to come up with a data structure containing information of interest
• Created numerous listing and summary tables using SAS
• Exported data from SAS into Excel and MS Access

Syntex (acquired by Roche) was migrating their clinical data warehouse from a IDMS/SAS environment to RxClinical/SAS environment. This project was being developed jointly with Oracle and was later offered to other companies as Oracle/Clinical. They were using SAS in a Vax/VMS environment.

• Worked with various departments to define Oracle views for Demography, Adverse Event, and Concomitant Medications, Terminations, Dosing and Laboratory data.
• Worked towards reconciling differences between data formats available from Rx/Clinical with that expected by the SAS programs
• Created SAS Access Descriptors to integrate existing SAS programs with Oracle.
• Made enhancements to Listing and Summary SAS programs
• Trained users in the use of SAS/Access to access denormalized Oracle views and Proc SQL Passthru facility to access normalized Oracle tables.
• Assisted in the development of business logic specifications documents

Matrix (acquired by Chiron) develops drugs to treat cancer. Created standard listings and summary tables to report adverse events.

• Worked on report layout and design using to report adverse events by treatment regimen and severity.
• Modified existing SAS programs and explored suitability of using data null versus proc report for report generation.
• Automated report generation process for different studies using Macro Language.

Systemix (acquired by Sandoz) was a start-up company engaged in gene therapies for cancer, infectious, and genetic diseases based on the use of human stem cells. They wanted to assess use of SAS software for clinical trial analysis.