Global safety reporting has become increasingly difficult for sponsors and sites to manage. Many sponsors overdistribute safety reports out of fear of non-compliance, which increases the cost of distribution as well as time spent monitoring compliance. Overdistribution puts pressure on already overburdened sites, which are forced to acknowledge receipt of the unnecessary reports. The problem of overdistribution also negatively impacts patient safety, as sites are actually more likely to miss important safety information in the avalanche of reports they receive.
In this one-hour webinar, industry experts Kendra Hayden of Hoffman-La Roche Limited, along with Steven Beales and Kristy Fusco of ePharmaSolutions, will explain how leveraging global expertise and using the proper technology solution can reduce the safety reporting burden and improve patient safety. The speakers will also present dramatic results achieved by a Tier 1 sponsor client using the Company's proprietary safety reporting solution.
Experts agree that the main obstacles to efficient, effective safety reporting include: 1) Lack of global harmonization in reporting rules; 2) Determining causality and; 3) Fear of regulatory repercussions. For more information about challenges in safety reporting, please read the article entitled "Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials," published in Vol 14, Issue 3, 2017 of the journal Clinical Trials.
In their 2015 paper, "CTTI Recommendations: Desired Attributes of Electronic Portals for Expedited Safety Reporting," the Clinical Trials Transformation Initiative (CTTI) recommends the implementation of a technology solution to address the challenges of global safety reporting.
In addition to a causality-driven reporting engine, which provides incentive for sponsors to accurately determine causality based on the 2010 FDA Final Rule and ensure proper distribution of safety reports, the ePharmaSolutions (ePS) technology-enabled solution is supported by a team of global experts who understand the complex safety reporting rules, and have worked together to create a centralized database of their knowledge. ePS offers the only solution which has been demonstrated to save clients millions of dollars while increasing patient safety.
Kendra Hayden
Functional Excellence Leader, Process and Safety
Kendra Hayden has been at Roche for 20+ years. During that time, she has held many roles such as a monitor, compliance and training, and process management.
Mrs. Hayden’s current area of focus is process management within clinical operations, specifically in the area of Global Safety Document Distribution for Investigators and Ethics Committees. Within this focus, she serves as the global process owner and project business lead.
Steven Beales
Senior Vice President, IT and Market Owner, Safety Solutions
Steven Beales is the Senior Vice President of IT and the Market Owner of Safety Solutions at ePharmaSolutions. An expert in the field of safety reporting technology, Mr. Beales has 25 years of experience in IT, and has spent over 16 years in pharmaceutical industry.
He joined ePS in in 2009 and led implementation of the Company’s Clinical Trial Portal at Genentech across 100+ countries. In 2015, he led implementation of Clinical Trial Safety Portal at a top 5 pharma organization, which included a data-driven rules engine configured with safety regulations from those countries, which saved this organization hundreds of millions of dollars. Over 50 million safety alerts have been distributed by these two portals via the cloud.
Prior to joining ePS, Mr. Beales was the Chief Software Architect at mdlogix, where he led the implementation of the CTMS systems for Johns Hopkins University, Washington University at St. Louis, the University of Pittsburgh, and the Interactive Autism Network for Autism Speaks.
Kristy Fusco, MLD
Product Manager, Safety Document Distribution
Kristy Fusco has been working in the pharmaceutical industry for almost a decade, and is currently the Product Manager of ePharmaSolutions’ Safety Distribution system.
Prior to joining ePS, Ms. Fusco was a Clinical Business Process Analyst at Shire Pharmaceuticals, where she maintained their CTMS system, and Global Data Management Specialist at Merck. She holds a master’s degree in Leadership Development and a bachelor’s degree in Nutritional Science.
- To understand the complexity of safety reporting regulations and to learn about technologies that help to centralize this knowledge.
- To learn how a causality-driven reporting engine can reduce site burden.
- To learn how sponsors can save time and money by avoiding over distribution.
- Chief Executive Officer
- Chief Technology Officer
- Chief Information Officer
- Chief Operating Officer
- VP of Pharmacovigilance
- VP of Safety
- Director of Pharmacovigilance
- Director of Safety
- VP of Clinical Operations
- Director of Operations
- Head of Pharmacovigilance
- Head of Safety
