IT Tools

i-TMS

The clinical operations hub to simplify study conduct and improve visibility

Our CTMS is designed to provide intuitive tracking of information and logical organisation of data. i-TMS enables stakeholders to track and report on the progress of clinical projects, and to make informed decisions based on quality data.

• Fully integrated with SOPs and FORMs (forms can be adapated to the needs of the sponsor)
• Monitoring and online monitoring reports
• Integrated validation process

e-REPORT

Online progress reports to support decision-making

Sponsor has access to online progress reports with possibility to export data with sorting and filtering functionalities (Excel files, graphs, charts). These reports provide a snapshot of the study progress, thus facilitating oversight of the clinical study and stakeholders activities, and support decision-making.

e-CRF

Integrated IT and Data Management development for consistent data

The ICTA eCRF is user-friendly with thorough validation documentation for electronic data entry. It is entirely hosted on ICTA servers in France .

• Developed in-house in compliance with the most advanced quality standards
• Compatible with main browsers on PC, Mac and mobile devices
• Customised home page: curves, newsletters, study documentation, etc.
• Overview of data entry, queries, signed visits, etc.
• Secure access defined per profile (Investigators, CRAs, DM, Sponsors, etc.)
• Automatic notifications and alerts (new patient, SAE etc.)
• Source Data Verification (SDV) management including audit trail and query management
• Remote monitoring activity management
• Fully integrated with data management activities from data management plan to database lock

e-PRO

The direct link between the patient and the clinical study

The ICTA ePRO is a robust and reliable system for patient-reported outcomes. It addresses our clients’ needs, can be customized to suit the study speficities, and provides quality data.

Principles of native application

• Accessible on smartphones/tablets with responsive design
• Transfer of data

Conditions to access the application

• Inclusion of the patient by the investigator
• After randomisation, unique access code issued and sent to the patient by the investigator
• Code associated to a password defined by the patient

Development platforms

• Mobile platforms used: development of a web application supported by the main types of platforms: iOS, Android, Windows

IWRS/RTSM

Random and Trial Supply Management solutions

The system proposed by ICTA allows fine-tuning of the randomisation algorithms and supply rules developed by the ICTA randomisation manager.

• Randomization
• Unblinding
• Supply / Resupply
• Acknowledgement of Receipt
• Dispensation

i-COM

Secure portal for communication and exchange of documents with the sites

• Accessible on smartphones/tablets with responsive design
• Send/Answer/View of messages
  –> From/To ICTA study team to site participants
  –> From/To sponsor to site participants
• Secured transmission of documents with limited patient identification data
• Global/grouped communication to sites (reminders)

EAP Platform

Secure and integrated data flows to address the specificities of Early Access/Compassionate Use programs

Functionalities

• Management and progress monitoring of EAP/CUP
• Tracking of administrative data on hospitals, HealthCare Providers (HCPs), and patients
• Follow-up of treatment orders
• Management of safety data
• Recording of contacts with HCPs to recover missing data and optimize consistent data collection
• Generation of standard EAP reports including a general report and detailed reports of included patients, refusals, treatment orders and contact details of all active HCPs
• Compliant with new requirements (Pasrel/ATIH and multi-factor authentication)

Electronic Data Capture

• Data entry by HCPs
• Online controls

Hosted on HDS servers in France