CRO Specializes in Biostatistics, Data Management, Medical Writing, Regulatory Submissions for Pharma and Bio-tech Industries
Cambridge, MA – June 4, 2003 – PROMETRIKA, LLC, a newly formed contract research organization (CRO), will present three posters at the Drug Information Association’s (DIA) 39th annual meeting, June 15-19, 2003 at the Henry B. Gonzalez Convention Center in San Antonio, TX. PROMETRIKA, LLC will exhibit in Booth # 730.
“The DIA annual meeting is a great opportunity for us to launch and introduce PROMETRIKA,” stated Dr. Miganush Stepanians, President and CEO of PROMETRIKA, LLC, who prior to founding the company directed the Biostatistics and Data Management Department at Muro Pharmaceutical/Viatris, Inc. for ten years. “Our team includes PhD level statisticians with solid experience in the pharmaceutical industry and academia. Our seasoned data management staff has extensive experience in the usage of CLINTRIAL™. Our size and low overhead allow us to be cost-competitive and efficient. We take pride in our proven track record of meeting timelines and delivering study reports within budgetary constraints. Furthermore, as former pharmaceutical company staff members, we understand the keys to successful sponsor-CRO collaborations.”
PROMETRIKA will present three posters on Tuesday, June 17, from 9:30 am to 4:30 pm at Bridge Hall, Gonzalez Convention Center. These poster presentations cover three topics germane to the practice of statistics for clinical trials from theoretical, practical, and regulatory perspectives. The titles of the three poster presentations are as follows:
Using Meta-Analytic Techniques in Sample Size Determination
Miganush N. Stepanians, PhD and Nicole M. LaVallee, PhD, PROMETRIKA, Cambridge, MA
The Use of Historical Controls in Clinical Trials
Brian A. Green, MS, Pfizer Global Research and Development, New London, CT; Nicole
M. LaVallee, PhD, PROMETRIKA, Cambridge, MA
Selected P-Value Adjustment Methods Applied to Clinical Trials
Heidy K. Russell, PhD, PROMETRIKA, Cambridge, MA; Ralph B. D’Agostino Sr., PhD, Boston University, Boston, MA
About PROMETRIKA, LLC
Founded in April 2003, the Cambridge, (MA)-based PROMETRIKA, LLC is a CRO serving the pharmaceutical and biotechnology industries in the areas of biostatistics, data management, medical writing, and regulatory submissions. With expertise and extensive experience in managing, analyzing and interpreting medical data, PROMETRIKA serves as an outsourcing partner to client companies and institutions. As former members of the drug development division at an international pharmaceutical company, PROMETRIKA’s staff members have a 10-year history of successful collaboration in the drug development arena including several new drug application approvals by the FDA and European regulatory authorities. This collaborative experience within a pharmaceutical company sets PROMETRIKA apart from other CROs.
PROMETRIKA’s seasoned professionals have in-depth knowledge of cGCPs and the ICH guidelines pertinent to study design, data management, biostatistics and programming as well as report writing and regulatory submissions. In addition to traditional contract research services, PROMETRIKA offers consulting services in SOP development, project management and FDA interactions.
About PROMETRIKA’s Founder
Founder, President and CEO of PROMETRIKA, LLC, Miganush Stepanians, PhD has 17 years of experience in biostatistics and data management. Her most recently held position was Director of the Biostatistics and Data Management Department at Muro Pharmaceutical/Viatris, Inc., which she joined in 1993. In this capacity, Dr. Stepanians headed a department of biostatisticians, programmers and data managers and oversaw the study design, data management and statistical analyses of approximately 100 clinical trials. Dr. Stepanians’ responsibilities included interacting with the FDA statisticians and other reviewers with respect to study design and statistical analysis issues and overseeing the preparation of the statistical portions of NDAs and CANDAs. As a member of several global development teams, Dr. Stepanians was a key contributor in the design of the company’s drug development programs. She has authored numerous statistical reports of clinical trials for FDA submission as well as a number of journal articles.
Prior to joining Muro, Dr. Stepanians worked as a project biostatistician first at the New England Medical Center and then at Boston University’s Statistics and Consulting Unit. During her tenure at these institutions, Dr. Stepanians provided statistical services for a number of pharmaceutical companies as well as the FDA, working on projects in a wide range of indications.
Dr. Stepanians received her Doctor of Philosophy in Statistics from Boston University in 1994. She received her Master of Science in Mathematics (Statistics) from Massachusetts Institute of Technology in 1984 and her Bachelor of Science in Mathematics and Psychology from Boston University in 1982
