Discover how a global pharmaceutical company, with North Highland as its transformation partner, cut submission timelines between the end of their clinical trials and submission to the health authority by two-thirds potentially unlocking $100M per submission. The program reimagined processes using digital solution automation, auto-generation and auto-prediction for end-to-end data integration with North Highland providing transformation leadership through program, project and change management.
The Challenge
Our client faced a competitive disadvantage: while their 24-week submission timeline sat at the industry median, leading competitors had accelerated to 10-12 weeks through data integration and automation. In pharmaceutical development, speed determines patent rights and market share—the first company to submit to health authorities typically wins both. This gap had real consequences: the client recently lost first-to-file positioning on a high-value therapy, ceding patent rights and over $100M in revenue to a faster competitor. The root causes were systemic: data fragmented across 15+ legacy systems, 60% manual document compilation requiring 40+ FTEs per submission, and quality reviews that surfaced errors too late to remediate efficiently.
The ambition was bold: reduce submission timelines to 8 weeks by the end of 2025 through what would become the Hyper Acceleration program, achieving parity with top competitors and protecting an estimated $100M in value per submission. To succeed, our client knew they needed more than recommendations. They needed a partner who could drive adoption, embed change, and flex as the program evolved.
The Solution
Working side by side with our client, our teams modernized their data management systems and developed an end-to-end change management plan that would accelerate submissions and transform delivery across the enterprise.
Together, we built a trusted, collaborative partnership that helped reduce time-to-market by driving key technological initiatives. To bring this transformation to life, North Highland led initiatives across change, delivery, and enablement. Our teams:
- Embedded into Workstreams: The team assessed each function's digital maturity and tailored support accordingly, enabling quick wins on immediate submissions while upskilling client teams to sustain changes independently.
- Automated Clinical Reporting: Intelligent automation was introduced to clinical study reporting, freeing scientific experts from manual compilations to focus on vital data interpretation and regulatory strategy.
- Built Lasting Change: Hands-on coaching, training programs, and Centers of Excellence equipped 40+ FTEs involved in each submission to uphold improvements after North Highland's departure.
- Streamlined the Ecosystem: The team coordinated multiple technology vendors across the delivery lifecycle, bringing governance and consistency to fragmented systems and ensuring people, process, and technology moved in concert.
The Impact
The results speak for themselves. By embedding directly into operations and driving change at every level, North Highland delivered measurable outcomes that transformed how our client brings therapies to market with impact felt across speed, value, and capability.
- 67% faster submissions. What took 24 weeks now takes 8, and we delivered it ahead of target. That's not just efficiency. It's patients getting access to life-saving treatments faster.
- $100M in value per submission. Speed to market directly translates to revenue protection and competitive advantage. North Highland's approach turned operational excellence into bottom-line impact turning vision into a reality.
- Enterprise-wide capability building. This wasn't a one-time fix. The frameworks, governance models, and ways of working we established are now being replicated across other critical programs, including study enrollment acceleration.
- A partnership built to last. Our client doesn't see us as consultants; they see us as an extension of their team. That trust has grown our relationship creating a scalable framework that is being repeated in other areas of their Clinical Trial process.
As their Business Lead shared in the 2024 Client Satisfaction Survey:
"North Highland provides a value for money service, they generate tangible inputs...not just loads of flashy slides! They flex their support to where it is needed in the project and they are a trusted partner that I feel comfortable discussing issues and ideas with."
Looking Ahead
Our partnership has grown from targeted project support to enterprise-wide transformation. The Hyper Acceleration program is more than a win; it is a blueprint for how pharmaceuticals can scale innovation and sustain competitive advantage across the business. We matched talent to the specific needs of each workstream, adjusted our support as priorities shifted, and embedded ourselves into teams until new ways of working took hold. Our client considers us part of their organization because we operate that way. The relationship keeps expanding because what we build together continues to deliver after the engagement ends.
Looking to make a change but not sure if it will stick? Just like this client, it’s vital to approach transformation in Life Sciences holistically, focusing not just on the technology implementation but also the change management, workforce strategy, and process standardization that will make it sustainable.
Business leaders can see similar value realization by:
- Establishing cross-functional content strategies early
- Engaging stakeholders upfront about quality expectations
- Addressing domain resistance through co-developed validation frameworks
- Preparing for the cultural shift in embracing automation as an augmentative tool
If you’re ready to take the next step with your transformation, contact our experts today.
