Nucleus

Nucleus is a cloud platform from Datatrial for people running clinical research. Despite its filing under church software, it is built for study teams who need to store and control trial documentation and datasets in one place.

It is designed for tightly regulated clinical settings, where document control and inspection readiness matter.

What Nucleus offers

• Nucleus Documents — cloud document and content management for quality documentation, with version history and access controls on each item.
• Nucleus eTMF — an electronic trial master file that collects regulatory documents from study start-up through to submission, replacing a paper file.
• Nucleus Coding — coding of terms against MedDRA and WHODrug dictionaries, with auto-coding and a review-to-approval workflow.
• Standalone API — lets the coding tool connect to data capture systems.

Who it works with

Clinical research teams and consortia that share documents between several partner organisations.

Key facts

• Offices: Newcastle upon Tyne, Alderley Edge in Cheshire, and Cambridge in the United States
• Dictionaries supported: MedDRA and WHODrug
• Features: full-text search inside documents and role-based access