Эксперт по клиническим испытаниям: переход к единому ответственному вендору необходим для создания новых цифровых конечных точек

Jiang Li, Ph.D., is the Founder and CEO of Vivalink, Inc. Many sponsors building wearable data workflows into clinical trials have gotten comfortable signing four or five vendors for a single study: a sensor company, an algorithm company, a cloud platform, a data integration layer. Each contract makes sense in isolation. The problem shows up later, usually around a protocol amendment or a data reconciliation question, when it becomes clear that no single party in that chain is accountable for the answer. After 11 years working in this space, I think that structural gap is the central operational problem in clinical wearables. Sponsors need to consider narrowing down their number of contracts by working with vendors who can take accountability for the full stack, from sensor to final dataset. What 'One Accountable Vendor' Actually Means One accountable vendor for the wearable data workflow means five things under one roof: regulatory-cleared hardware built for clinical use rather than repurposed from consumer wellness; native firmware and signal processing co-designed with the hardware rather than grafted on afterward; a platform that owns edge, cloud and the path between them so provenance is never lost at a handoff; integration-ready data with a full audit trail produced continuously by design; and a single contract, support team and point of contact when something goes wrong mid-trial. That last criterion sounds operational, but it has real clinical consequences when a safety signal surfaces and the medical monitor needs answers quickly. One clarification worth making, because experienced sponsors will rightly raise it: Single-vendor accountability is not the same as lock-in. The model only holds up if it includes genuine interoperability, data portability in standard formats and no proprietary fences around the sponsor's own data. Accountability without portability trades one fragmentation problem for another, and sponsors are right to ask for both before signing. Vertical Integration: The Precondition For New Digital Endpoints There is a deeper reason this matters, and it is the one I find myself returning to most in conversations with pharmaceutical R&D leaders. The more consequential opportunity in clinical wearables is not replicating legacy endpoints remotely but building endpoints that did not previously exist: continuous atrial fibrillation burden as a clinical measure, multi-vital safety signatures for cytokine release in oncology, early decompensation indices that integrate multiple physiologic streams. Developing those endpoints requires control of the entire signal chain, from the sensor's sampling rate and the firmware's filter parameters through to the cloud platform's timestamp synchronization, because every vendor boundary in that chain becomes a place the validation package has to defend rather than the signal itself. Multi-vendor arrangements may be workable for endpoints already validated against established gold standards, where the interfaces are well understood and the tolerances are known. For genuinely novel digital endpoints, that structure introduces friction that is difficult to engineer around, particularly as the regulatory bar for digital health technologies continues to rise. Whether vertically integrated wearable companies ultimately scale better than partnered-stack alternatives is still being sorted out in the market, and the answer may differ by therapeutic area and endpoint complexity. But this is a question sponsors should be actively asking their wearable partners, alongside the downstream one: What does the vendor model cost in regulatory speed and endpoint development if the architecture turns out to matter as much as the data? Forbes Technology Council is an invitation-only community for world-class CIOs, CTOs and technology executives. Do I qualify?