The 2024 World Class RIM℠ Benchmark study is now enrolling companies that would like to participate in the study when it reopens September 9th.
This “industry standard” survey was our 45th regulatory study since 2007 and was conducted from February through May of this year. It was our 7th RIM study since 2013 and the most comprehensive to date. It focused on the following goals:
- 1.) Determine where industry is increasing their regulatory operational performance and what are their investment priorities
- 2.) Compare study participant “Top Performers” to “Everyone Else” to quantify leading practices that lead to “High Performance”
- 3.) Provide the latest update on short and long-term strategies for structured data management and Health Authority Initiative status
- 4.) Explore the priority and technique of RIM connections to other functions systems and enterprise capabilities (MDM, Data Lakes, etc.)
- 5.) Review data governance practices and their relationship to data quality levels
- 6.) Explore how advanced technologies are being applied along with their investment priorities / budgets
- 7.) Detail the regulatory provider system landscape (market share levels, satisfaction scores, innovation index, service partners)
For those companies that could not participate this spring, the World Class RIM study will re-open on September 9th and close on October 31st. Please use the form to the right to enroll.
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, automation use cased, and a detailed view of the 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.
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.