Upcoming Events
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Miganush Stepanians, PhD, President and CEO, will be a Keynote Speaker at the 7th Annual New England Rare Disease Statistics (NERDS) Workshop 2024.This year’s workshop theme is: Leaping Forward: Innovative Statistical Approaches in Rare Disease Drug Development. PROMETRIKA is pleased to join our statistics colleagues in the industry at this exciting event.
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Andrew Park, PharmD, PROMETRIKA’s Senior Medical Writer, will be hosting a roundtable on The Art of the Clinical Protocol QC at the American Medical Writers Association’s (AMWA) 2024 Medical Writing & Communication Conference. Protocols are known for being hotbeds for confusion and inconsistencies, especially in their initial form. Since they are often based on a previous and unrelated protocol, involve input from multiple internal and external teams, and need to incorporate increasingly complex study designs, it is not surprising that such issues arise. How can we ensure the final product accurately reflects the team’s intent? Andrew will explore and share common sources of inconsistencies, QC steps to identify them, and approaches to avoid inconsistency in the first place.
Past Events
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Kathy Zheng, MPH, Director of Project Management and Clinical Innovations, will be speaking about Using AI in Clinical Operations, Data Management, and Science: A Practical Blueprint for Streamlined Clinical Trials at the SCDM 2024 Annual Conference in Boston on Sept. 29 - Oct. 2. Please attend the session if you are interested in hearing about the AI landscape from a CRO perspective. -
PROMETRIKA is proud to support the Taiwanese biotechnology community as a Silver Sponsor of the 2024 BTBA 12th Annual Symposium. Join us, along with over 400 young professionals from biomedical-related fields worldwide, at this exciting event.
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Peiwen Yu, MS, Biostatistician III, will be presenting his paper “A New Scoring Method for Ordering Components within the Composite Endpoint in Oncology Trials” at the 2024 Joint Statistical Meetings (JSM). In clinical trials, patient-reported outcomes (PRO), encompassing multiple scales, have been widely used in measuring patients’ quality of life, especially in oncology trials. Hear his proposal for a semi-prioritized generalized pairwise comparison (GPC) method that avoids the need for a strict order of PRO scales while simultaneously preserving the importance of the primary endpoint. -
PROMETRIKA to Attend ASCO 2024
PROMETRIKA will be attending the 2024 ASCO Annual Meeting this year. Join Neil Wohlford, MS, PROMETRIKA’s Associate Director of Biostatistics and Leader of DMC Services, at this exciting event. Neil will be representing our DMC Center of Excellence as he gathers with oncology professionals worldwide. -
PROMETRIKA to Present at TIDES USA 2024
Aileen Ryan, MS, PROMETRIKA’s Senior Regulatory Affairs Advisor, will be presenting a session titled “Regulatory CMC Strategies for Early Peptide Development“ at the TIDES USA 2024 conference. Limited experience in peptide manufacture (typically one preclinical lot and one clinical lot) presents challenges with setting specifications and supporting data. The presentation will discuss issues and challenges in early peptide development with a focus on strategies and priorities of small companies including case studies with FDA feedback. -
Miganush Stepanians, PhD, PROMETRIKA’s President and CEO, will be participating in the Data Science Organizations panel discussion at the Pharmaceutical Data Science (PharmDS) Conference hosted by the New England Statistical Society (NESS). The panelists will share their experiences, insights, and best practices in building data-driven cultures and driving innovation within the pharmaceutical industry. -
PROMETRIKA to Attend IAPP Europe Data Protection Congress 2023
Barry Mirrer, PROMETRIKA’s Head of Quality Assurance, will be attending the IAPP Europe Data Protection Congress this year. Join us as we gather with Europe’s data protection professionals to gain insights about strategic developments in regional and international data protection. -
PROMETRIKA to Lead Panel Discussion at Medidata NEXT New York
Please join us at Medidata NEXT in New York City on Tuesday, November 7th at 1:30pm ET. Miganush Stepanians, PhD, PROMETRIKA’s President and CEO, and Benny Chan, PROMETRIKA’s Senior Biostatistical Standards and Implementation Specialist, will participate in a panel discussion with industry experts titled Innovative Approaches for Tackling Complex Trials.
Recently, there has been a tangible increase in study complexity. Complex trials pose new challenges for study teams, including patient recruitment, informed consent and retention, data management and interpretation, statistical and logistical complexities, regulatory hurdles, and stakeholder cooperation. This panel discussion will center around strategies to address trial complexity and simplify trial conduct by design.
What you will learn in this session:- The impact of the problem on clinical trials today (Patient, Site, CRO, Sponsor)
- Success stories in handling various complex trial designs
- Future opportunities to run complex trials more effectively
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Join Andrew Park, Senior Medical Writer, at the AMWA 2023 Medical Writing & Communication Conference, where he will be leading a roundtable discussion about how varied experience can strengthen medical writers and how best to broaden it.