Regulatory Advanced Technology Pulse Survey: Comparing Industry and Provider Readiness / Maturity / Value
Study Introduction
Our spring 2024 World Class RIM study technology landscape section focused on regulatory digitization maturity, advanced technology use case identification / status, learnings from unsuccessful proof of concepts, advanced technology investment priorities for 9 baskets of technology, and estimated 2024 and 2025 advanced technology budgets. While we were pleased with what we learned, there is still a large gap in what is perceived to be possible and the current reality (hype gap) in our humble opinion.
The goal of this follow-up study is to explore different dimensions of industry readiness (data, process, skills, metrics, etc.) with software provider readiness (maturity, timelines, value etc.). We will also explore several organizational processes surrounding rationalization of use case ideas, assigning /realizing business value, and workforce development. The study will include industry and software provider views of when different advanced technologies will have their tipping points (2025 – 2030 view).
We look forward to your participation.
- We expect between 30 – 50 companies to participate along with 15 software providers
- Study opens on October 21st and closes on December 11th, 2024
- We expect the time to review and complete the study will be 1 – 2 hours
- Study results will be available to all study participants by the end of January 2025
- A community debrief will be conducted in February 2025 while members have an option to schedule a private debrief
- A Study Guide and Entry Video will be available to support participating organizations
- There is no cost to participate, study is blinded, participants receive full results
To enroll in the study or request further information, fill out the form below.
Survey Team
We have a very talented research team to support this study
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
Preeya Beczek MS (supporting research since 2023) has 25 years’ experience across the life sciences industry. She has led regulatory projects across the entire product lifecycle in various therapeutic areas and platforms. Preeya has held roles at PAREXEL, GSK, Pfizer, JNJ, Ipsen, DOW Chemicals and worked with many other organisations as part of her client base/professional network. She has extensive industry experience and insights to lead and support teams across regulatory functions, in order to meet objectives. She has undertaken many large strategic and operational projects to help organisations reach operational effectiveness and increase regulatory compliance. (e.g., labelling alignment between core and local versions, critical phase submission management, inspection preparation/readiness for EMA and MHRA, standardisation of global submission management processes; designing and establishing risk management and governance frameworks; building the full RA and cross functional infrastructure for first MAH product).
Preeya is an excellent facilitator and a ‘critical friend’, working with clients and cross functional teams operationally and as a subject matter expert. She is passionate about creating effective teams, processes, toolkits and operating models for RA teams to enable global collaboration, data quality and compliance. Preeya holds a Bachelor of Science degree in Chemistry and Management Studies and a Master of Science in Environmental Strategy from the University of Surrey, UK. She is also a qualified Lean Six Sigma Green Belt.