Survey of Statistical Study Design and Analysis Methods for Rare Disease Development Programs
Miganush Stepanians, PhD, President & CEO, PROMETRIKA, LLC
May 2021
Closing The Real-World Evidence Gap: Pragmatic Clinical Trials & Observational Studies
Miganush Stepanians, PhD, President & CEO, PROMETRIKA, LLC
Dr. Robert Califf, MD, MACC, Vice Chancellor for Clinical and Translational Research, Duke University
Jane Liang White, ScD, Senior Director, Statistical Group Lead for Oncology Hematology Franchise, Pfizer
Rebecca Miksad, MD, Senior Medical Director, Flatiron Health
Massachusetts Biotechnolgy Council (MBC)
December 2019
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Putting patients first: taking trials & technology home
Heather Paden, MS, Head of Clinical Operations
Presented at Medidata NEXT in New York
November 2019
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Lessons learned from implementing risk based monitoring (RBM)
Chelsey Ryan, PMP, Senior Manager, Clinical Trial Management
Massachusetts Biotechnolgy Council (MBC)
October 2019
From Protocol to Package Insert: A Data Journey
Alex Rohall, Senior Manager, Medical Writing
Christine Quagan, Senior Medical Writer
Presented at AMWA Medical Writing & Communication Conference in Washington DC
November 2018
The Era of Flexible Monitoring Models: Centralized Real-Time Data Review and Utilization of Targeted Source Document Verification
Heather Paden, MS, Head of Clinical Operations
Presented at Medidata NEXT in New York
October 2018
Why Rave EDC?
Amanda Rychel, PhD, Senior Project Manager
Presented at Medidata NEXT in New York
October 2018
Migration of Rave Coder
Cathy Hult, Director of Data Management
Presented at DIA Global’s Annual Meeting in Boston
June 2018
Update to RaveX – It’s Worth It!
Diane Siegel, Principal Data Manager
Presented at DIA Global’s Annual Meeting in Boston
June 2018
Study Conduct I: Study Conduct Medical Coding (Keys to Success in Medical Coding From A to Z)
Cathy Hult, Senior Manager, Data Management
Presented at 2017 Medidata NEXT Global in New York
November 2017
Patient Engagement: ePRO Data Integration with Rave: Case Studies With and Without Patient Cloud
Kathy Zheng, MPH, Senior Project Manager
Presented at 2017 Medidata NEXT Global in New York
November 2017
Support Site: SDV…What is it Good For? Absolutely Nothing?
Stephen Cropper, Senior Clinical Research Associate, Clinical Operations
Presented at 2017 Medidata NEXT Global in New York
November 2017
Clinical Data Management: Data Storage or Data Science?
Cortney Greenhalge, Clinical Data Manager II
Presented at SCDM’s Annual Conference in San Diego
September 2016
Who Does the “B” in BYOD?
Kathy Zheng, MPH, Senior Project Manager
Presented at SCDM’s Annual Conference in San Diego
September 2016
A Case Study: What MD Anderson Requires for its Complex Studies and the Boutique CRO that Provides the Perfect Model
LuAnn Sabounjian, RN, BSN, MBA, Head of Clinical Operations and Drug Safety, PROMETRIKA, LLC
Presented at Clinical Operations in Oncology Trials 2016
July 2016
Digital Health: Implementation Challenges to Best Laid Plans
Kathy Zheng, MPH, Senior Project Manager, PROMETRIKA, LLC
Massachusetts Biotechnology Council (MassBio)
July 2016
Balance®: Drafting an RTSM Team and Training for Go-Live
Kathy Zheng, MPH, Senior Project Manager, PROMETRIKA, LLC
Presented at the 2015 Medidata Symposium
October 2015
Patient Cloud®: Implementation Challenges and Other Lessons from Beyond Go-Live
Kathy Zheng, MPH, Senior Project Manager, PROMETRIKA, LLC
Presented at the 2015 Medidata Symposium
October 2015
Current Trends and Best Practices for Data and Safety Monitoring Boards; A Joint Medical and Statistical Perspective
Miganush Stepanians, PhD, President & CEO, PROMETRIKA, LLC
Candida Fratazzi, MD – President, Boston Biotech Clinical Research (BBCR), LLC
Massachusetts Biotechnolgy Council (MBC)
May 20, 2010
Current State of Special Safety Analyses for Clinical Trials
Miganush Stepanians, PhD, President & CEO, PROMETRIKA, LLC
Massachusetts Biotechnolgy Council (MBC)
November 20, 2008
Planning and Development of Integrated Summaries of Safety
Miganush Stepanians, PhD, President & CEO, PROMETRIKA, LLC
Massachusetts Biotechnology Council (MBC)
November 15, 2006
Data Management for Non-Data Managers
Colleen M. Cox, CCDM Manager Data Management, PROMETRIKA, LLC
Massachusetts Biotechnology Council (MBC)
June 9, 2006
Data Management in Support of A Clinical Event Committee (CEC)
Colleen M. Cox, DIA Data Management,
March 20, 2002
Meta-Analysis of Five Adult Environmental Trials Evaluating the Efficacy of Azelastine Eye Drops, 0.05% in Symptomatic Patients with Seasonal Allergic Conjunctivitis
Miganush Stepanians, PhD, Muro Pharmaceutical, Inc., An ASTA Medica Company
March 20, 2001