The review objective
The Trial Telemetry pre-FPI review examines whether a trial can generate the signals its protocol, safety oversight, and operating decisions require. Kevin’s framework brings this examination into planning, before live execution reveals avoidable gaps. The method is a published advisory design rather than a claim of completed engagements for named sponsors.
Signal and source feasibility
The review starts with what the trial needs to know and when it needs to know it. Each signal is connected to its source, collection workflow, responsible party, timing, definition, and intended use. That makes it possible to examine whether the proposed data path can support the decision.
The method distinguishes event time from entry or receipt time. A quickly refreshed view can still reflect information entered well after the underlying event. The review therefore examines collection and handoff latency as part of the design.
Endpoint, device, and participant readiness
The framework considers whether endpoint-related collection fits the protocol and the participant’s actual experience. Devices, connectivity, availability, support, data completeness, and site responsibilities can all affect whether information arrives as intended.
Kevin’s experience with Rarify, eCOA/ePRO, and global service delivery, together with his non-production Dexcom integration development, provides the foundation for this analysis. The pre-FPI method organizes those concerns into a focused review rather than assuming that selection of a vendor resolves them.
Site burden and handoffs
A site may work across multiple studies, systems, and vendors. The review examines duplicate effort, workflow friction, handoff ownership, escalation, and the practical burden imposed by the technology stack. It also considers what happens when a source is missing, a device stops transmitting, or an expected step is delayed.
The aim is to identify an accountable response path. A risk that appears in a report still needs someone to investigate it and a defined way to act on the finding.
Governance and outputs
Kevin’s model calls for traceability among the original information, the rule or interpretation applied, the review decision, and the resulting action. It considers authorization, source context, quality expectations, privacy, and change management.
Useful review outputs would include a signal inventory, source/workflow map, ownership and escalation definitions, identified failure modes, and a bounded readiness plan. These are intended deliverables of the method, not completed study artifacts represented as historical results. The method can support sponsors, CROs, product teams, and clinical technology leaders evaluating a new data or endpoint pathway.
Sources and record basis
- Published work productTrialTelemetry.com · Published framework
Kevin’s public framework and advisory perspective for governed clinical-trial signals. A published framework is distinct from a completed client deployment.
- White paperTrial Telemetry · May 2026 white-paper page
Public introduction to the May 2026 paper. The separate site requests contact details for its PDF; this archive provides an openly readable account of the framework.
Trial Telemetry and pre-FPI review are authored frameworks. Their records do not establish completed client engagements or measured deployment outcomes.