Gens & Associates’ new World Class RIM℠ study identifies “secret recipe” for Regulatory functions’ “future readiness” — and it has little to do with AI

Press Release

Gens & Associates’ new World Class RIM℠ study identifies “secret recipe” for Regulatory functions’ “future readiness” — and it has little to do with AI

Fresh benchmark data from 59 life sciences organizations finds most biopharmaceutical companies currently ill-equipped for a “confluence of change” already underway and pinpoints the foundational practices behind a widening performance gap.

Newtown, Pennsylvania, USA – April 15^th, 2026 - Gens & Associates’ 2025 Operational Excellence and World Class RIM℠ study now available, reveals that only one life sciences company in 59 is genuinely prepared for the period of disruption ahead. The international study, now in its 47th cycle and widely recognized as the industry standard benchmark for regulatory information management, is based on detailed responses from 59 organizations spanning pharma, biologics, medtech, and gene therapy.

As well as measuring current operational excellence, this latest benchmarking cycle introduces a Future Readiness Indicator (FRI), gauging how well organizations are positioned for the period of rapid change ahead. Gens & Associates points to a “confluence of change”: the combined impact of AI, cloud-based regulatory spaces, data aggregation platforms, structured data mandates, and workforce transformation within a 2-3-year window. Today, of the 59 study participants, just one achieves “ready and leading” status while 21% are classified as being “at risk.” The remaining 77% are “developing”, with clear areas for development.

“Strong current performance does not automatically translate into future resilience,” said Steve Gens, Managing Partner and founder of Gens & Associates. “Organizations that invest deliberately in process maturity, data governance and accountability, and organizational agility are closing the foundational gaps they need to take a step back and leap forward. Those that don’t will find the performance gap widening.”

Other standout findings

Data accountability is the hidden differentiator

The study identifies end-user data accountability — where individuals and teams are explicitly responsible for the accuracy of data in their systems — as a still-rare but high-impact capability. While only 4 of the 59 organizations have it as a strength, those organizations record 93% aggregate data quality confidence versus 50% for everyone else, and operational efficiency approaching 94%. Across this “top performer” cohort, data quality confidence stands at 81% versus 43% for the rest — with the gap sharpest for specific authoritative sources: 100% versus 44% for Health Authority Commitment tracking data.

“The combination of mature data governance and clear data accountability — that is the secret recipe,” Gens said. “In Regulatory, accountability has always been about dossiers. Getting it down to the data level is still fairly new — but the performance difference it makes is extraordinary.”

Process maturity is a performance multiplier — and it is measurable

Benchmarked for the first time this cycle using a structured five-level model based on Capability Maturity Model Integration (CMMI) principles, process maturity across nine core regulatory areas directly predicts business outcomes. A comparison of top performers versus the rest reveals:

• Operational throughput benefits achieved: 80% vs 47%
• Time-to-filing improvement, secondary markets: 70% vs 26%
• Operating cost improvement: 90% vs 39%
• User productivity and effectiveness: 90% vs 50%

This performance advantage holds regardless of software provider or system strategy — consistent across every research cycle since 2014. The differentiator is not technology, but rather the organizational and process layer beneath it.

AI investment is high; returns are recalibrating

47% of companies report AI pilots or implementations underway — and 100% of large companies are making significant AI investments. But of 131 benefit-realization responses tracked across all AI and advanced automation use cases, just two exceeded expectations. Broad consensus on implementation timelines has shifted to 2027–2028. Although near-term returns are emerging in clinical document generation and AI-assisted translation, the data confirms that while AI amplifies strong foundations it cannot compensate for them.

AI payback so far  is underwhelming but will improve as companies’ use of the technology evolves. “Think about ERP in the 1990s,” said Gens. “People expected ROI in two years, and it took 7-10. But was it a worthy investment? Absolutely. AI is the fourth game-changing technology — after the PC, the internet, and the smartphone. The better your foundations, the better your return will be — period.”

Other notable findings include:

• Cloud-Based Regulatory Spaces (CBRS) are approaching a tipping point: 41% of companies are already participating with such platforms, 48% plan to join within a year, and 71% believe CBRS will fundamentally change how industry works with health authorities within five years — from one-to-one submissions to a single dossier reviewed simultaneously by multiple health authorities. Pilots have produced impressive results[1].
• Regulatory’s investment in a Business Excellence function has surged from being true for 38% of organizations in 2022 to 90% today, reflecting Regulatory’s evolution from document factory to cross-functional data orchestrator.
• Change management remains unevenly applied: 71% apply a structured approach to technology change, but only 47% apply the same rigor to process or data change — directly undermining many transformation efforts.

The full 2025 Operational Excellence and World Class RIM℠ study white paper is available from Gens & Associates. For the paper, membership, advisory services, or further information, visit https://gens-associates.com/world-class-rim-research/

About Gens & Associates

Founded in 2005, Gens & Associates Inc is a life sciences benchmarking and advisory firm focused on improving client performance and guiding strategic transformation. Its World Class RIM℠ benchmark data is widely regarded as the industry standard, cited by analysts, solution providers, and thought leaders, and extensively used across the sector.

The firm’s global network comprises seasoned professionals with deep experience across industry, government health agencies, and leading consulting firms, primarily based in Europe and North America. In 2017, Gens & Associates was named in the PharmaVoice 100, recognizing it as one of the most influential and inspiring organizations in the life sciences industry. More at www.gens-associates.com

PR Contact   Carina Birt, Sarum Life Sciences   carina@sarumlifesciences.com    +44 (0)7970 006624

[1] Accumulus Synergy Powers Industry’s First Digitally Generated Dossier to Nearly Two Dozen Countries Simultaneously. Accumulus Synergy/Global Newswire, February 2025: https://www.globenewswire.com/news-release/2025/02/05/3021294/0/en/Accumulus-Synergy-Powers-Industry-s-First-Digitally-Generated-Dossier-to-Nearly-Two-Dozen-Countries-Simultaneously.html.