The 2024 World Class RIM℠ Benchmark study is officially launched.
This “industry standard” survey is our 44th study to date and is expecting record breaking participation of 80-100 organizations. We will continue our World Class RIM research surrounding RIM program strategy, peer operational performance comparison, investment priorities, advanced technology application, data governance practices, global program effectiveness, organizational culture, along with our comprehensive software and service provider landscape. We are excited about our new section focusing on Regulatory Digitization.
The study opens on January 8th, 2024 and closes on April 12th with results expected for each participating company by late May. Our seven industry survey design sessions completed last year with 44 organizations contributing to the final design at these locations:
- Europe (onsite): Copenhagen, Zurich, and London
- United States (onsite): Lambertville, NJ, Boston, San Francisco
- United States (hybrid): Chicago
By participating in our study, your company will gain the latest industry recognized RIM research (typically over 100 pages) of key trends and practices, your company’s performance position relative to industry peers and our World Class RIM performance levels, actionable insights, top performer practices, and a detailed view of the service and software provider landscape. The study is blinded, no cost to participate, and you get the full results along with debriefing options.
If your company has not participated before, watch our short video to learn our benchmark history and value, 2024 study focus, and our research policy and rules.
Participants use the survey data and debrief sessions in many ways including:
- Create or confirm internal strategy and investments.
- Incorporate practices and performance metrics contained in the survey to improve operational performance.
- Understand how they compare to peers generally and their performance rating in our World Class Performance Benchmark specifically.
- Understand common industry challenges, investment priorities, and program goals from their peers.
- Gain detailed knowledge and analysis of the software and service provider landscape including current market share, satisfaction ratings, likelihood to change, and standing in our innovation index.
- Educate senior leadership on regulatory information trends, challenges, and opportunities.
Industry Enrollment for Study Participation
Introduction
The following short videos are intended for companies that are enrolled in the study. A member of the Core Research Team provides additional context and guidance for each section / question in the study.
Introduction – Mobilizing your Team
Section 1: Demographics
Section 2: Organizational Strategies and Program Status
Section 3: World Class Questions
Section 4: Connections and Data Quality
Section 5: Structure Data Management
Section 6: Technology and Automation
Core Research Team
We have a very talented research team to support this study which we will be expanding this fall.
Steve Gens is the survey co-founder with the first industry survey conducted in 2007. The 2018 World Class RIM follow-up will be the 33rd survey conducted under Steve’s leadership. He has over 30 years of business experience with the majority in the biopharmaceutical and healthcare industries. His early career was spent at Johnson and Johnson and then moved into consulting where he managed several healthcare consulting practices for Booz Allen Hamilton and First Consulting Group.
Steve has deep experience in strategy formulation and implementation, organization development and performance, industry benchmarking, information management strategy, and facilitating strategic change. He consults for many large global biopharmaceutical companies and with small high growth organizations. He has a Master of Science in Organization Development from American University with distinction for his field work and a BS in Business Computer Science. Steve is a frequent speaker and was named as one of the 2017 PharmaVoice 100 for his contributions to industry.
Greg Brolund of Chicopee Falls Consulting (supporting survey process since 2009) is a management and technology consultant with experience with global Pharmaceutical companies in product labeling, submission publishing, Health Authority interactions, pharmaceutical safety and pharmacovigilance programs and ICH eCTD, E2B and HL7 ICSR electronic submissions.
He has over 25 years of experience in all aspects of information technology including the Food and Drug Administration’s drug review process and supporting systems and as Chief Technology Officer for the US Department of Health and Human Services. He holds a Masters of Chemistry degree from the American University in Washington DC. Greg can be reached at gregbrolund@cfalls-llc.com
Kelly has 20+ years’ experience in the biopharmaceutical industry, leading IT, RIM, and Regulatory Operations organizations in several companies including Wyeth, Pfizer, Shire and Teva. She has led implementation of large-scale global systems and processes, and is passionate about the potential for pharma companies to raise the bar on productivity and compliance through process-focused management of critical data. Kelly a member of the EMA SPOR Task Force and its PMS subteam, is a member of ISO TC/215, and is also Vice President of IRISS (www.iriss-forum.org).
Kelly has expertise in the structure and function of global regulatory organizations from both an organizational/business process and a systems/data perspective, and founded K2 Consulting (www.k2rim.com) in 2018 to support global regulatory organizations in identifying, defining and implementing the most effective processes and capabilities for their specific situations and needs. Kelly can be reached at kelly.hnat@k2rim.com
Katherine Yang-Iott is a core member of the Gens and Associates team with over 15 years of experience in the healthcare and pharmaceutical industry leading and managing complex interdisciplinary projects. She worked as a research scientist at Regeneron Pharmaceuticals and The Children’s Hospital of Philadelphia before transitioning to consulting work, where she focused on strategy development, change management and continuous improvement projects to support research operations.
Katherine has a Master’s of Science in Organizational Dynamics from the University of Pennsylvania and a Bachelor’s of Science in Biochemistry. Katherine can be reached at kyang-iott@gens-associates.com.