Ownership in an Outsourced World: Rethinking Control of Clinical Data in MedTech 

The Accountability Paradox 

There is a silent paradox running through modern clinical research. Over the past two decades, the industry has steadily handed more of its operations to external partners: CROs, technology vendors, specialist consultancies; while regulators have moved in precisely the opposite direction, demanding that sponsors retain ever-greater accountability for the evidence they generate. 

The result is an unusual kind of accountability gap. Under ICH GCP and equivalent global standards, the sponsor cannot delegate ultimate responsibility for data integrity, patient safety or the reliability of a study’s findings. That obligation is theirs, regardless of who built the database, who manages the platform, or who holds the server keys. Yet in practice, many sponsors find themselves unable to access their own data in real time, dependent on intermediaries to interpret it, and locked into structures they neither designed nor fully understand. Accountability sits with them; control often does not. 

For large pharmaceutical companies, this tension is uncomfortable but manageable. They have the resources, the legal teams and the negotiating leverage to impose terms on their vendors. For small and mid-sized MedTech manufacturers, it is a more serious problem. 

Who owns the clinical evidence? 

Clinical evidence in medtech is much more than just a regulatory box to tick. It is the mechanism through which a device earns CE marking or FDA clearance; the input that shapes reimbursement decisions, and (if generated through a pivotal study) frequently the single largest capital investment a young company will make. When that evidence is generated on platforms that the sponsor does not own, in data structures they cannot easily export, through processes that sit several layers removed from their direct oversight, the risk extends beyond the operational and into the strategic. The data that should be the company’s most durable asset can end up effectively belonging to someone else. 

The uncomfortable truth is that much of the infrastructure built to support clinical research was designed with large pharma in mind. Lengthy build cycles, enterprise licensing models, and systems that require specialist intermediaries to navigate were never optimised for lean medtech teams running first-in-human studies or pivotal trials on constrained timelines. The industry has largely adapted by accepting these constraints as the cost of doing business. At Franklyn Health we think that is the wrong conclusion to draw. 

Outsourced, but fully in control 

Outsourcing itself is not the problem. Access to specialist expertise, the ability to scale capacity without building permanent headcount, the efficiency gains that come from working with experienced partners, these are genuinely valuable, and for most small and mid-sized MedTech companies, they are not optional. The question is whether outsourcing has to come at the cost of ownership. We do not think it does. 

This is the thinking behind our partnership with Ledidi. Their platform was built around a different set of assumptions: that sponsors should have direct, real-time access to their clinical data without needing to route requests through a vendor’s support team; that study design should be something a sponsor can engage with meaningfully, not a technical process handed entirely to specialists; and that the data generated in a study should remain genuinely portable, usable in future submissions, post-market programmes and registry contributions without requiring a data liberation exercise every time. 

The Ledidi Clinical Trials Platform 

The platform is validated for regulated research, meeting GCP requirements and FDA 21 CFR Part 11, with ISO 27001 and SOC 2 Type II certification. But compliance is the floor, not the differentiator. What matters for our clients is that it is designed for transparency rather than dependency. 

For Franklyn Health, this shapes how we deliver studies. Our role as a CRO has always been to serve the sponsor’s objectives; not to become a layer of complexity between them and their own evidence. That means being deliberate about the technology we use and the access it provides. A sponsor should be able to see exactly where their study stands, understand their data without additional cost or translation, and leave a programme with assets they can actually use. That is not a novel idea. It is just one the industry has not always prioritised. 

The terms of Outsourcing need to Change 

The MedTech companies driving the next generation of diagnostics and devices are, in many cases, small. They are working on tighter budgets, with leaner teams, under the same regulatory expectations as companies ten times their size. They deserve infrastructure and delivery models built with that reality in mind; not adapted versions of systems designed for someone else. 

Outsourcing will remain central to how clinical research gets done. But the terms of that outsourcing are worth examining more carefully. Sponsors should not have to choose between leveraging external expertise and retaining meaningful control of their own data. With the right partners, that is not a trade-off at all. 

 Written by Rob Bedford, 17 March 2026