Post-Merger Clinical Operations Support for an Oncology Division
Clarkston Consulting recently partnered with a client on a post-merger clinical operations support for an oncology division. Read a synopsis of the project below or download the full case study.
Download the Post Merger Clinical Operations Support Case Study Here
The client specializes in the development and commercialization of oncology therapies for various tumor types. They acquired the clinical assets from another biotechnology company and were looking to fully integrate all ongoing clinical trials and operations with the new sponsor. Clarkston was engaged to assess and develop a strategic plan to successfully integrate all clinical assets (from the US, EU, and several other global markets) during a ~six-month window.
Clarkston leveraged its deep expertise in clinical operations and M&A integrations to guide the client through a series of complex and interconnected steps, ensuring the seamless transition of critical clinical assets and processes. As a trusted partner, Clarkston provided an in-depth strategic assessment, project management, and subject matter expertise to develop a comprehensive integration roadmap that aligned key functional areas and mitigated risks.
Our work helped the sponsor define the necessary organizational and operational changes by identifying interdependencies and prioritizing critical activities across clinical functions. Working closely with the head of Quality, as well as clinical study directors and clinical supply leaders, we conducted a thorough assessment to map out regulatory document updates, sponsor label change requirements, and SOP transitions, ensuring compliance and operational continuity.
To drive execution, we developed a master integration framework, which included a detailed action plan with assigned ownership, clear milestones, and progress tracking. This disciplined approach ensured cross-functional collaboration and alignment, enabling the organization to meet aggressive timelines while maintaining high standards of quality and compliance. At project completion, all clinical assets were successfully integrated within the target six-month window, reinforcing Clarkston’s ability to lead organizations through high-stakes clinical transformations with precision, agility, and strategic insight.
