One Platform to Research, Document, and Collate your Clinical Data.

Simplify your research data with the Nucleus platform. A single platform to store your study documentation, clinical datasets, submission data and compliant media.

Take Control with Datatrial Nucleus

Nucleus Documents

Content management and version control for your quality documentation and media. Control, manage, and share company content with ease.
  • Version Control and History
  • Audit Trail
  • Access controls per item
  • Tagged Items
  • Full content search inside documents
  • Encrypted at Rest
  • Two Factor Authentication

Nucleus eTMF

Successfully manage your clinical trial master file documents from study startup to submission. Inspection ready, controlled access to eTMF documentation.
  • All of the control of Nucleus Documents plus:
  • Standardized Structure per Organisation
  • Reference Model based design
  • Granular access per role
  • Automated metadata assignment

Nucleus Coding

WHODrug or MEDDRA based medical coding for your study data. Standalone or integrated into NowEDC or your own system, Nucleus Coding is a cloud based environment to quickly and easily code your clinical term data.
  • WHODrug and MEDDRA support
  • Full dictionary search
  • Standalone API for integration into your data capture tools
  • Auto-code against dictionary terms
  • Coded term review workflow

Document Management

Providing faster access to data for your team is essential to accelerating your research. Nucleus Documents provides your team with cloud based document and content management for your quality documentation. Built for use in GxP environments, Nucleus helps streamline your document access whilst maintaining the highest level of compliance you demand.

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eTMF for your Regulatory Documents

Nucleus eTMF allows your study team to collate and control your trial documentation in the cloud. Whether replacing your current paper Trial Master File, or running your latest study eTMF, Nucleus eTMF can help improve both your teams compliance and inspection readiness.

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Medical Coding

Standalone or Integrated into your EDC tool - Nucleus Coding allows your clinical team to code against both MedDRA and WHODrug dictionaries following a fast and efficient workflow. Auto-code or manually code terms as required, and push those terms though review to approval to ensure quality in your final datasets.

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‘Nucleus has had a great impact on the iMATCH and SAMPLE projects that I lead. These are large consortia each with 10 or more partners working to scale-up activity in the field of Advanced Therapies. Nucleus allows us to share and update documents in a really efficient way incorporating full version control. This is really valuable when working together on such big projects.’

Prof Fiona Thistlethwaite – iMATCH

Interested in seeing how Nucleus Document Management or our Electronic Trial Master File can help empower your clinical research?

Request a demo and a free trial to try it out for yourself. We’re waiting to hear from you!

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