A biotech sponsor running seven concurrent studies, including five Phase III trials, required more than CRO delivery support. Frequent change requests, tightly connected study designs, compressed timelines, and the need for consistent decision-making across the portfolio demanded strong leadership, transparent governance, and specialist expertise. Veramed provided a portfolio-wide model combining strategic oversight, technical excellence, and proactive program management, enabling the sponsor to maintain progress across multiple parallel studies while delivering critical Phase III analyses to quality and timeline expectations.
The challenge
The sponsor was advancing an ambitious late-phase development program comprising seven concurrent studies, including multiple interconnected Phase III trials. Success depended on maintaining consistency across studies, managing overlapping timelines, and coordinating decisions that could have implications across the wider development program.
Study requirements evolved frequently in response to new data and priorities. The sponsor needed support to assess and understand the impact of these changes across the multiple interconnected studies, analysis plans, timelines, and future submissions. Additionally, maintaining momentum while preserving quality required not only delivery capacity but also strategic leadership capable of guiding decisions and managing change across the portfolio.
With these challenges in mind, the sponsor sought a partner that could provide the level of expertise, oversight, and accountability typically associated with a larger CRO, while remaining agile enough to support an evolving biotech organization.
The solution
To address the challenges of this demanding program, Veramed delivered a structured, highly coordinated solution to support across the sponsor’s whole portfolio, led by a proactive and dependable point of contact.
Leadership and strategic oversight
Veramed established experienced portfolio leadership from the outset, providing a central point of oversight across all studies. This ensured the sponsor had access to strategic guidance on the downstream implications of study changes, helping maintain consistency across interconnected protocols and deliverables.
Transparent governance and portfolio management
Dedicated program leadership and structured governance provided visibility across the sponsor’s entire portfolio. Regular portfolio reviews, coordinated stakeholder engagement, and proactive management of study interdependencies ensured risks were identified early and timelines remained aligned.
Specialist expertise when needed
As study complexity increased, Veramed supplemented core teams with specialist statistical expertise to support advanced methodological requirements. This ensured the sponsor had access to the right expertise at the right time, strengthening confidence in key strategic and analytical decisions.
Transparent budget management
To support evolving study requirements, Veramed introduced enhanced budget visibility and change-management processes, helping the sponsor understand the impact of emerging requests and make informed decisions with full transparency.
“I’ve been extremely pleased with the work Veramed has done. It feels like they are part of the team and that they care about the work they are doing. They take on more responsibility than I’ve seen from other CROs, and they make my life easier!”
Client Lead
The outcome
Two years into the program, despite the inherent duration of Phase III studies, the client has already achieved several significant milestones:
- Delivered topline and full primary analyses for the first two Phase III studies running in parallel while maintaining agreed quality standards.
- Achieved 100% of agreed KPIs, with approximately 80 metrics assessed to date.
- Maintained a 100% sponsor quality review pass rate across deliverables reviewed to date.
- Built a trusted strategic partnership, with Veramed becoming an integral extension of the sponsor team.
- Expanded the relationship through additional awarded work packages beyond the original Phase III portfolio.
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