To be a premier
highly customized statistical analysis and data management services
for discerning clients in the pharmaceutical and medical device
analysis and reporting services for independent data monitoring
committees in the pharmaceutical industry.
Business Strategies <TOP>
solutions using the SAS® software system. Provide a highly skilled
core of employees, augmented by retaining the services of independent
has worked in the pharmaceutical industry for well over 20 years,
beginning as a Senior Biostatistician with Adria Laboratories in
1978. His last position before starting his own company was Director
of Statistical Services at Harris Laboratories, Inc. During his
career, he has conducted or supervised statistical analyses of all
phases of clinical studies for CNS, gastrointestinal, cardiovascular,
and cancer pain products. The work included protocol development
and report writing for U.S. and European companies.
Associates, Inc. has served as the independent data management and
statistical analysis organization supporting a data monitoring committee
established to review safety and efficacy for the following international
Currently serving as the unblinded data analysis center (DAC) for
a 10,000+ patient study of postmenopausal women with mortality one
of several primary endpoints. When we assumed DAC responsibility
the study had been running for 2 years, the DSMB had lost confidence
in the original DAC, and the Sponsor had begun to transfer data
management activities to an in-house team. The DSMB was on the verge
of terminating the study because it believed that patient safety
could not be adequately monitored. In less than 7 months we validated
the randomization schedule against original medication kit numbers,
obtained and met the DSMBs reporting requirements, completely
revised the safety report with consistent reporting across tables,
and prepared a draft interim efficacy report. Along the way, we
merged 4 overlapping adverse event data streams, converted adverse
event tables from COSTART to MedDRA, and convinced the sponsor to
develop special search categories of MedDRA terms targeting adverse
events of interest for this class of drug and indication.
expanded interim safety report convinced the DSMB that patients
were not being placed at increased risk and regained the DSMBs
confidence in the sponsors data management plan.
We produce quarterly safety updates, arrange and conduct face-to-face
meetings at 6-month intervals with the sponsor and the data monitoring
committee. As secretary to the DSMB, we prepare and circulate the
meeting minutes and file all DSMB related documents until the end
of the study.
Served as the independent unblinded data analysis center (DAC) for
the data and safety monitoring board (DSMB) of an ischemia prevention
trial with 2200 planned patients. The responsibilities included
generating a randomization schedule, 24-hour turn around of monthly
safety reports, and producing efficacy interim analyses for DSMB.
In this project, we also served as secretary to DSMB, scheduling
tele-conferences, recording and circulating minutes and filing all
DSMB related documents until the completion of the study. In addition,
data validation and decoding of biomarker data, and Monte Carlo
simulation were performed at the sponsor's request.
Due to highly
effective and real time analysis support, the DSMB was able to provide
a timely study termination recommendation for the safety reason
just after 350 patients enrolled.
Served as the independent unblinded DAC for a 2300 patient study
in sepsis. We produced and validated SAS programs to sponsor specifications.
We assisted the sponsor in database validation and prepared unblinded
two interim statistical analyses. We assisted the sponsor in verifying
treatment assignments while the sponsor was blinded to treatment.
700 patient study of a novel intraocular lens. We advised the client
on the best method of obtaining information from a legacy database,
developed and assisted in the implementation of a data management
plan, provided a statistical analysis of the validated database,
and served as the statistical member of a team presenting results
to a medical devices panel at the Food and Drug Administration.
owner served as a consultant to Restoragen, a biotech company located
in Lincoln. He provided regulatory affairs support, retained and
supervised study monitors, assisted with protocol writing and study
design, developed randomization schedules, designed and supervised
the production of case report forms, audited CRO performance, computed
sample size estimates, performed statistical analysis, and reviewed
has performed the data management for two integrated summaries of
safety. Both products, Actiqä and Kadian, are on the market.
For Anesta Corporation, the makers of Actiqä, we provided advice
on the format and content of tables in the integrated summary of
safety. We also created a standardized safety database from the
legacy data. For the Kadian submission, we prepared standardized
SAS datasets that were then used to create a standardized safety
database. We also helped write the final draft of the integrated
summary of safety.
D. OMeara, Ph.D - Owner
Ph.D. Mathematical Statistics, U. of Iowa
SAS® V8 Certified
OMeara - Senior SAS Consultant
SAS® V6 Certified
The SAS System Version 8.2
GRAPH, IML, ETS, AF, EIS, SCL, ACCESS
Enterprise Miner, SAS Warehouse Administrator
StatExact, SPlus, NQuery
Small Business Server