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ITClinical Overview

Company overview
by

Miguel Almeida

on 18 February 2014

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Transcript of ITClinical Overview

2006-2013
taking IT to the next level
Created in 2006
Knowledge bridge between
IT
Scientific
Languages
About ITClinical
The team
Pharmaceutical sciences
Medical
IT & Engineering
Biomedical
Collaboration
With our partners
R&D:
Collaboration with Universities
Master degree thesis
Offer our technical expertise in areas that are not the core business of our partners
Taking IT to the next level
Language Affairs
IT Affairs
Technical translations (instruction manuals, scientific articles)
Localisation
Technical proofreading
Network of translators
Phramacovigilance
IWRS
EDC

Investigational Product Management
Software Validation
Store AE/ADR information
Manage the company's medicinal products
Assist in the preparation and management of Periodic Safety Update Reports (PSURs).
Import and export cases in the E2B XML format
Bibliographic searches
E2B compliance
PSUR generation
Medicinal products dictionary
CIOMS generation
Store AE/ADR information
Manage the company's medicinal products
Assist in the preparation and management of Periodic Safety Update Reports (PSURs).
Import and export cases in the E2B XML format
Bibliographic searches
E2B compliance
PSUR generation
Medicinal products dictionary
CIOMS generation
Multi-site access using a web-browser
Randomisation of patients
Stock management features, auto-resupply triggers
Customiseable randomization algorithms
CFR part 11 compliant
Validated
Legacy Computer Systems not Validated
Off-the-shelf Software such as Microsoft Word and Excel not Validated
Inadequate Storage and Back-up
Inspection Findings
http://www.labcompliance.com/solutions/expert_advice/part11/fda_inspections_2004-2007.aspx
Accountability of investigational products
Manage products at different locations
PDF generation on product movements
Partnership models
Portfolio apps
Tailor made apps
Hosted at provider
Hosted at client
Software-as-service
One-off fees
Local partnership
Global success
Instant Audit Trail
Advanced Edit checks
Trial and site Data export
Monitoring features
Online query management with formal approvals
t
CRO/Sponsor/Investigator
Trial Master file archival
Document archival
Monitor reports
Contact organizer
EDC
CTMS
Investigational Product Management
Full transcript