On April 28, 2026, Pharma IT - a ProductLife Group company - brought together clinical operations professionals, data managers, and pharmaceutical specialists in Copenhagen for a full-day event focused on one of the industry's most pressing challenges: translating ICH GCP E6(R3) into effective, day-to-day sponsor oversight.
The room included representatives from more than ten companies - from emerging biotechs running their first global trials to established pharma organisations managing complex multi-CRO programmes.
What emerged over the course of the day was a picture both candid and revealing: the challenges of sponsor oversight are widely shared, and the gap between policy and practice remains wider than most would like to admit.
"One of the biggest risks sponsors still underestimate is assuming that outsourcing responsibility also outsources accountability. It doesn't." - Trine Stougaard Bak
The transition from E6(R2) to E6(R3) is often described as a shift in emphasis. In practice, it represents a more fundamental change in how regulators and inspectors expect sponsors to think about oversight.
Under E6(R3), the question is no longer whether sponsors have documented that oversight occurred. The question is whether oversight is actually managing risk - and whether sponsors can demonstrate that it is doing so effectively, across the full trial lifecycle.
Quality by Design is no longer optional framing: it is an expectation. Inspectors increasingly focus on whether QbD thinking was embedded from protocol development onwards - and whether those discussions were documented, even when CROs led the work. Risk-proportionate approaches must be backed by clear reasoning, not just referenced in SOPs.
Perhaps most significantly, E6(R3) draws a hard line on accountability. Activities can be delegated. Accountability cannot. Sponsors remain fully responsible for the quality and integrity of trial conduct - regardless of how much has been outsourced - and inspectors are paying close attention to whether governance structures genuinely reflect that.
Over-reliance on checklists and KPIs, without a clear understanding of where the critical risks actually lie scientifically, operationally and from a data integrity perspective, is a pattern inspectors are increasingly flagging. The guidance is explicit: oversight that matters is not the same as monitoring more.
The afternoon focused on the tools and operating models that sponsors can use to structure oversight more effectively - led by Kasper Langelund Jakobsen, who brought a practitioner's perspective to the FSO and FSP frameworks.
The FSO model offers real advantages: scalability, and the ability to draw on CRO capabilities across large or complex programmes. But it comes with structural challenges that the day's earlier discussion had made vivid - system access limitations, blurred boundaries between sponsor and CRO responsibility, the complication of managing multiple CROs simultaneously, and the risk of delays when the sponsor cannot act directly.
The FSP model inverts some of these trade-offs. It keeps critical functions closer to the sponsor, makes oversight more manageable, and supports the development of a more mature internal organisation. The cost implications - both in terms of resource requirements and potential long-term savings - depend heavily on programme size and complexity.
Regardless of model, the tools used to demonstrate oversight carry significant weight in inspection settings. Minutes and action logs, oversight plans, issue and decision logs - these must be maintained in systems that support an audit trail. SharePoint, for all its convenience, is not GxP-validated and should not be used for essential documents. System-to-system integrations between sponsor and CRO environments can be technically challenging due to CRO-specific customisations, and require careful planning.
A consistent message across both sessions: the documentation of oversight must be proportionate, purposeful and auditable - not exhaustive for its own sake, but sufficient to demonstrate that governance was real.
One of the concrete solutions discussed during the event was DAIMI - a platform developed by Pharma IT and ProductLife Group to address the structural gaps that make sponsor oversight operationally difficult.
The DAIMI Sponsor Oversight module is built around a systematised oversight plan that automatically generates oversight activities and assigns them directly to the relevant roles - removing the manual coordination burden that often leads to gaps. The platform can integrate directly with CRO systems, allowing sponsors to review and link essential records from the CRO environment without leaving the oversight workflow. This means one place for all oversight activity, rather than a patchwork of trackers and email threads.
DAIMI can be accessed across multiple vault environments - covering clinical, quality, regulatory and other functions - enabling different functions within a sponsor organisation to conduct their oversight activities in the same system, with consistent processes and a shared audit trail.
The platform can be implemented as a standalone solution or integrated directly with an existing vault environment, depending on the organisation's needs.
The event was designed and led by Trine Stougaard, Director of Clinical Science, Medical Writing and Regulatory at Pharma IT, and Kasper Langelund Jakobsen, Senior Consultant at Pharma IT and part of the Digital Veeva Center of Excellence.
Trine brings more than 19 years of experience in the pharmaceutical industry, with deep expertise in clinical drug development, post-launch non-interventional studies, and global clinical trial operations. With a strong background in project and team management, she brings a practical and collaborative approach to Sponsor Oversight.
Kasper is a Veeva Vault specialist with extensive experience in Vault Clinical applications, including eTMF, CTMS, and Study Start-Up. He has led system optimisation, validation, and stakeholder engagement initiatives across major pharmaceutical organisations and brings strong expertise in Sponsor Oversight, digital processes, and clinical operations. He also established an informal Sponsor Oversight working group within Vault Clinical, which now includes participants from 20 different sponsor organisations.
The day in Copenhagen surfaced something that tends to get obscured in regulatory guidance documents and conference presentations: sponsor oversight is not primarily a compliance problem. It is an operational and organisational challenge - one that requires clear governance, the right systems, and a genuine shared understanding of what oversight is for.
The challenge is no longer understanding the guidance. It is making it work on a Monday morning, across multiple partners, systems, and teams - in a way that holds up when inspectors ask how oversight was actually conducted.
If sponsor oversight is something your organisation is actively working through - whether that means building the processes, selecting the systems, or strengthening governance - the Pharma IT and ProductLife Group teams are available to help.
Get in touch with Trine Stougaard Bak or Kasper Langelund Jakobsen to start the conversation.
Pharma IT - a ProductLife Group company - delivers experienced, competitive and professional IT and drug development consultants to the pharma, biotech and medical device industries. On a mission to raise the standards of consulting by challenging the way it is usually done, Pharma IT invests in attracting and continuously educating the best consultants in the industry - staying current with the latest trends, regulations and certifications so clients don't have to.