Healthcare & Life Sciences · Iberia
Four CROs, one study record, from first-in-human to submission.
Four companies came together under one name, and brought four ways of keeping a study. Now every study has one record that a regulator, an investor and its own team read the same way.
Four houses, one brand
The organisation is a full-service European CRO headquartered in Iberia, running Phase I to IV and real-world evidence studies, with its own hospital-based Phase I unit. It was formed by bringing several CROs under one brand, with many completed trials between them in oncology, neurology, immunology, vaccines and rare diseases.
Each kept a study its own way: different data-capture builds, different document trees, different conventions for the same CDISC domain. A sponsor's data package, and the inspection behind it, depended on which one had run which part.
One governed study model
With NRY, the organisation built one study model on Blackwave. Protocols, case report forms and tabular data from every part of the organisation land in one structure, mapped to the submission standards it already works to. Whitestorm agents assemble the deliverables from it, with the organisation's own people reviewing every page that matters.
What changed for a sponsor:
From one study to the portfolio
The model that carried the first study now carries the portfolio. Each submission leaves structured, reusable evidence behind it. That is what the organisation means when it says data is the currency of drug development: the package that satisfies a regulator is the one that convinces an investor.