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i-CRFs / i-WRS

i-CRF, ICTA’s web-based data collection tool

As part of its full-service, ICTA offers to its clients its own e-CRF, a system entirely consistent with its secure project and data management processes.

Acknowledged as a major solution to simplify the management of clinical studies, with data captured at source, the i-CRF improves the quality of the data collected and adjusts to any type of projects, whether sequential or adaptive clinical studies, epidemiological studies, expanded access programs (ATU, RTU)…, and to adaptive monitoring requisites (on-site or remote).

The i-CRF is a powerful and customizable tool which allows collection and automatic online edit checks of the data captured in compliance with the Data Validation Plan, as well as integration of manual medical queries.

Flexible, scalable and user-friendly, the i-CRF offers all advanced functionalities customized to each project user profile: investigator, study nurse, clinical research assistant (CRA), data manager, project manager, medical reviewer, etc.

Developed according to a client-server architecture and in compliance with the 21CFR Part 11 and ICH / GCP, the i-CRF does not require any user installation and is accessible via the Internet with the different browsers available. It is secured with 128-bit encryption and confidential username and password changed every 90 days.

Icrf ICTA Home Mini Icrf ICTA Sites List Mini Icrf ICTA Patients Mini
Home page of the i-CRF customized for study needs List of sites only accessible with a Project Manager profile List of visits per patient

 

Icrf ICTA Form Mini Icrf ICTA Queries Mini
Data entry form Display of queries

 

Its main characteristics are:

A home page customized to each project with a profile-dependent access that allows downloading of study documents (protocol, synopsis, SAE forms, guidelines, video tutorials, newsletters, etc)
The easy navigation from summarized charts and reports on data capture progress via authorized accesses
The “clever” addition of patient visits according to the study flowchart and the patient’s cycle, essential option when dealing with adaptive clinical studies
The integration of conditional items
The triggering of online queries as data capture progresses (queries issued, resolved and confirmed online)
The integration of data manager’s profile to allow follow-up of “critical” queries
The check module to verify source data (SDV) by visit, page or item
The process to modify/adjust throughout the study progress (amendment to the protocol, additional controls, workflows, etc)

Integrated to ICTA’s i-SIT platform, the i-CRF offers compatible specificities such as:

Dashboards which synthesize and/or detail information on study progress, patients inclusions, provide status reports on data capture, monitoring (SDV performed), queries with issued, ongoing or resolved statuses, SAEs, etc.
Sending of alert e-mails triggered after the recording of key data in the i-CRF (patient inclusion, recording of AE with a severity criterion, protocol deviation…)

Besides, the i-CRF allows project teams (CRAs, project manager, data manager, medical reviewer) to ensure the follow-up of the data via a read only mode access and to extract data in different formats (AE, audit trail, or upon request, any other clinical data relevant to the project). 

Standardization of the i-CRF kernel (portal, navigation…) allows maximization of development time mainly focused on the study specificities, i.e. :

  • Variables and audit trail
  • Checks, queries and conditional items
  • E-mail notifications
  • Addition/adjustment of profiles when necessary

 

i-WRS

IWRS solutions are developed by ICTA’s IT department according to the same quality standards as those applied to the i-CRFs.

They are dedicated to the management of patients randomization (centralized or by site, stratified or not, etc). Depending on the project, the i-WRS can be directly integrated into the study i-CRF.

i-WRS can also be developed for other applications relevant to project management such as: follow-up of drug supplies, specific logistical aspects (cell therapy, others, etc)