Product

EDC, Clinical Data Management, eTMF and ePro.

ACTide eTMF

Our eTMF is designed for clinical professionals to support studies of any scale and is backed by a complete cloud-based document management system to structure studies’ document workflows.  Real-time collaboration amongst Sponsors and CROs now becomes the new standard.

Complete study lifecycle

  • Manage your documents and workflows from study start-up to study decommissioning.
  • Boost your study by providing site administrators, sponsors, and CROs an online tool to create, store, view, edit, and collaborate on a TMF repository within a single – easy to use interface.
  • Make your Site Files (ISF) talk to each other for real-time document access, review, and exchange. Transfer key documents from sponsor’s TMF to site’s ISF with a click.

 

Nubilaria ACTide eTMF   Nubilaria ACTide eTMF

 

eTMF FEATURES

Collaborate

  • Share documents collected from Sponsor, CRO, sites and countries in a centralized repository for real-time access, review, and exchange.
  • Perform quality checks automatically to find missing signoffs and missing documents.

Activate

  • Keep your teams up to date with a document status tracker

Manage

  • Stay in control by using granular profile-based access.

 

Nubilaria ACTide eTMF   Nubilaria ACTide eTMF

 

eTMF BENEFITS

  • Manage all documents in real-time to ensure compliance and audit readiness throughout the trial.
  • Search and get access to all your documents without any hassle.
  • Directly sign documents in the same app and be notified of any modification or any signature that is missing to complete the workflow.
  • Save costs by increasing your filing efficiency, reducing paper, errors and impact of high workloads

Choose your essentials
Start with a simple configuration and easily scale to a full-service setup of your TMF.

Essential configuration Advanced options
Base Document management system Quarantine protection for file uploads
Minimum set of approval workflows Strict workflows to avoid missing steps
Use of electronic signature Use of a full integrated digital signature solution
Reminder system to alert for missing steps in workflows Advanced reporting
Use an essential reference model Mobile integration for managing/editing TMF documents on the go
Complete DIA TMF reference model
Integrated viewer for common file formats


Be compliant

  • Compliant with CFR 21 Part 11, GDPR, and HIPAA regulations.
  • Compliant with extensive audit trails, access control, lifecycle management and version control of clinical documents and records.
  • Support for the Drug Information Association’s (DIA) TMF reference model.

 

Nubilaria ACTide eTMF Nubilaria ACTide eTMF

 

 


ACTide eCRF

Web-based interface natively cross-platform and device ready. Configurable role-based permission system.

ACTide eCRF provides your study team and site Investigators with all the required tools and services to succeed in their daily tasks plus the freedom of a Software as a Service:

  • Online randomization (IWRS)
  • Multi-laboratory normal ranges set up and management
  • AE and SAE management
  • SAE safety database
  • Drug Management
  • Online Medical Coding (MedDRA, WHO Drug Data Dictionary)
  • Double Data Entry and reconciliation
  • Monitoring tools eQuery management
  • Query Builder for information retrieval
  • KPI Dashboard


ACTide Designer

Drag & drop form builder. Reuse of study building objects & custom templates.

ACTide Designer is our powerful application to design, use, re-usu and deploy eCRFs and their requirements, including:

  • Metadata definitions
  • Visits, Sections, Entry-points
  • Multi-purpose edit-checks: mandatory, visibility, consistency, warning
  • Annotated CRF, study level validation templates

ACTide Designer is the ideal application to:

  • Train your junior staff using an intuitive and easy-to-use interface.
  • Build and share CRF template libraries between project management teams and clinical operations

 


ACTide ePRO

  • Native ePRO integration including email & SMS reminders
  • Support for photo upload and phone-native functions

 


ACTide Clinical Data Management

  • Real-time reports
  • Data export to Excel, SAS, SPSS

 


ACTide Medical coding

  • Integration with WHODrugs, MedDRA, others In-line and off-line coding service

 


ACTide Randomization & Trial Supply Management

  • Randomization & advanced allocation
  • Drug supply management & logistic with inventory control

 


Data Security

  • Live and backup EU hosted servers
  • Encrypted communication

 


Support

  • One2One total support
  • eLearning with online documentation and certification program

Our support team is composed of qualified professionals with a broad experience in developing eCRFs of any complexity and scale. It includes:

  • Project Managers
  • Clinical Data Managers
  • Quality Assurance Managers
  • Developers
  • Statisticians

 

 

 

ACTide - request a demo

Time & Budget

High productivity performance
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Compliance

High security standards
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Want more information about our solutions?
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