EVENTS & PRESENTATIONS

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.

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.

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

Watch the Presentation

PROMETRIKA will be attending the AICROS (Association of International Clinical Research Associations) Annual Meeting 2023, hosted by our AICROS partner, Clinexel Life Sciences Pvt Ltd in Mumbai, India. AICROS is a consortium of small to mid-size CROs that collaborate to provide clinical research services to the biotechnology, pharmaceutical and device industries worldwide. PROMETRIKA is excited to meet with all our international partners face-to-face and look forward to exchanging ideas about the support of global clinical trials.

Chelsey Ryan, MSHS, PMP, PROMETRIKA’s Director of Clinical Operations and Pharmacovigilance, will be co-leading the AICROS (Association of International Clinical Research Associations) International Project Management Training Workshop. AICROS is an alliance of local and well-established CROs, and we combine our strengths and know-how to accomplish the global clinical development goals of our clients. We are excited about the opportunity to convene with our AICROS partners at this unique event to learn and share insights about how to effectively manage complex global clinical trials.