At the Veeva Clinical Oversight Forum in Copenhagen, we spoke with Ibrahim Kamstrup-Akkaoui, VP of Business Architecture and Partnerships at Novo Nordisk, about how sponsors should think about outsourcing under the evolving R3 framework.
Kamstrup-Akkaoui emphasized that outsourcing decisions must start with strategy, not efficiency alone, noting that sponsors need to be clear about which functions directly shape trial outcomes. He explained that activities tied to interpretation, judgment, and program direction require closer proximity to the sponsor, while large-scale operational execution can often be externalized. “You can outsource a lot of the operational bulk, but the critical decision-making and analysis are things you want to keep close,” he said.
Discussing early study design, Kamstrup-Akkaoui highlighted medical and biostatistics functions as areas that should remain tightly linked to sponsor strategy. These teams influence how programs are framed, how risks are assessed, and how outcomes are interpreted, making them less suitable for full outsourcing. In contrast, execution-focused activities may be better handled by CRO partners when aligned to clear standards.
He also introduced the importance of infrastructure ownership as a risk mitigation lever. Running partners on sponsor core systems, he explained, preserves data consistency, traceability, and oversight while reducing integration complexity. This becomes especially critical in high-velocity studies where near real-time data monitoring enables faster decisions.
Kamstrup-Akkaoui urged sponsors to retain strong internal medical oversight to protect patient safety and scientific integrity. “From my experience, it’s probably the medical function you want to keep in house,” he said.
This content is sponsored by Veeva.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
