Phase 3 investigator platform

Four associated respiratory studies were running in parallel, each with its own investigator community, its own site list and its own set of materials. The sponsor was managing them as four separate engagement problems, which meant an investigator working across two studies received two of everything and had no way of telling which version applied to which protocol.

Then a critical protocol change landed. It had to reach every investigator, in every country, in a form that could be evidenced — and it had to reach the right investigators for the right studies, without re-training people on a protocol they were not running.

We built one hub for all four studies, with tailored environments inside it. Access was resolved per investigator and per study, so a site working on two protocols saw two sets of material clearly separated rather than one merged pile — and a site working on one saw only what applied to them.

The protocol change was handled as a designed engagement rather than a document distribution: targeted training built specifically around what had changed, resources released to the affected environments, and structured comprehension checks so that “we sent it” and “they understood it” were different measurements. Community features ran alongside, so investigators could put questions to the study team and see the answers other sites had already received.

The whole thing ran on SmartLab, which meant participation, completion and comprehension were recorded as they happened rather than reconstructed afterwards.

Over 2,000 investigators across 40 countries were brought onto a single platform spanning four studies. The protocol change reached the affected investigator population with targeted training, a resource set and a comprehension record, and the sponsor had one place to answer the question the change had made urgent: who has seen this, and can we show it?