ICE eCRF

Integrated Clinical Environment
Platform for the creation of validated eCRFs

ICE is an innovative software platform devoted to the management of Electronic Data Capture and Clinical Data Management and is designed to make every part of the clinical investigation process more efficient.

Developed by engineers of the Politecnico

ICE is the only validated clinical data acquisition software, which enables investigators to build their own studies, simplify the process of data collection and at the same time significantly reduce the clinical trial costs.

Features:

  • User creation and management using group policies
  • The system for capillary management of permissions
  • Graphic folder personalization function della cartella
  • Software compliant with FDA CFR 11
  • Software compatible with the privacy policies at the national level, in particular to Italian privacy policies
  • Software validated according to GAMP 5
  • Area dedicated to monitor, with the possibility of scheduling of visits and extraction of KPIs
  • Area dedicated to the data manager, with the possibility of having dedicated KPIs
  • Policies for complete management of the system
  • Functionality by inclusion of dictionaries (MEDDRA, WHO, etc.)
  • Customizing Controls, including those that manage the flow
  • Compatibility with mobile devices
  • Exportable Audit Trail with logical exploration
  • Managing updates to eCRF and automatic structuring of the versions
  • Integrated warning and alerting system
  • The integrated system of data change management (eQuery)
  • Possibility of long term storage on our servers, and/or storage on a durable medium
  • Randomization integrated feature,enabled also for center stratification
  • Dedicated reporting system
  • The possibility for creation of a duplicate intended to test each eCRF released
  • System updates during production (real time), even in the presence of data
  • Customizable monitoring plan

Altre informazioni

AdvicePharma is an Italian company that develops services and technologies for data and information management in the medical-scientific field. The company mission is to develop and provide quality services through the selection of the best technological and professional resources.

TUV Certificazione

Advice Pharma Group Srl is a UNI EN ISO 13485:2016 certified company for the provision of services for third parties for design, development and testing of standalone software medical devices intended for monitoring, diagnosis and therapy.

TUV Certificazione
Advice Pharma Group Srl is a UNI EN ISO 9001:2015 certified company
TUV Certificazione

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