ICE

Integrated Clinical Environment

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. 

EDC Features

  • Easy to use design environment: no IT skills required to design an eCRF
  • 100% web-based technology 
  • Compliant with FDA Guidelines
  • Built-in eQuery module with edit check system
  • Real-time data export: compatible with different formats (SAS, excel, SPSS, R)
  • Real time randomisation module
  • Innovative system structure based on several different databases
  • Key study management modules already built‑in on the platform (e.g: Clinical Trial Management System, AE Modules)
  • Customised reports with online access
  • Security-compliant architecture provides a protected environment for your data
  • Geographical distributed and redundant back‑up of server data
  • On-line training for platform users
  • Compliant with the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679)

Characteristics of the Software:

  • 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
 

Advice Pharma is an Italian company that develops technologies and services for the management of data and information in the medical-scientific sector. The company mission is to develop and provide quality services, through the selection of the best technological and human resources.

TUV Certificazione

AdvicePharma has been certified UNI EN ISO 9001:2015 for the following scope: Design and development of information systems for collection and statistical processing of data of clinical and epidemiological trial in the pharmaceutical and biomedical field. Design and provision of consultancy services for clinical and epidemiological trials in the pharmaceutical and biomedical field. (IAF 33, 35)

Advice Pharma Group Srl

via Durando 38/a
20158 Milano Italy
c/o Polihub Politecnico di Milano

Tel. +39 02 2399 2985
Fax +39 02 3206 6961
Email info@advicepharma.com

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