PHARMA INK.DATA
Digital Pen & Paper in Clinical Research

The Digital Pen & Paper's technology use in the clinical research studies ensures the biggest freedom and competence in ward or in ambulatory because the operations of data collection may be carried out far from the computer. In fact during the medical inspection it is possible to fill in the CRF simply writing on the apposite printed form. Later on, it is sufficient to link the pen to a computer in order to convey automatically the information to the central system.

The ink.data service uses the innovative Digital Pen & Paper technology to offer new methods for the collection and management of clinical data: the data written by hand on the paper CRF by the Investigator is automatically transmitted via internet and made available to the users in various digital formats.

GM offers Digital Pen & Paper technology in the Service Provisioning mode with various configurations organized according to increasing service plans:

1 In the basic configuration (Level 1 - Image Collection) the ink.data service provides to access via internet to the central repository for the storage of images and completed forms/folders, visualizing the writing methods and times coming from the Investigator.
The use of the ink.data service, in this basic configuration, optimizes the time required for acquisition of clinical data, without burdening the Investigator with the necessity of interacting with a Remote Data Entry system.

2 The configuration of the service (Level 2 - Image Recognition) includes the conversion/recognition (with a quality process) of the images received by the system, into organized data and made available in a database, or in any case exportable and available for retrieval via internet in the most common interchange formats (TXT; XML; Excel; Access; etc.).
This configuration is particularly suited for observational clinical studies which involves qualitative levels that are not absolute and can fully benefit from the collection speed and a process of data recognition that guarantees the match between the data in the data base and that received from the Investigators' pens.

3 The configuration of the service (Level 3 - Data Validation) includes the completion of the recognition process with the validation of the data, obtainable through a final comparison of the information present in the paper source document (CRF) with the data acquired through the pen by the Data Management system.
This configuration includes all of the formal quality control procedures and corresponding Validation protocols of a clinical study on paper carried out in the traditional manner.

4 the most extensive configuration (Level 4 - Full Clinical Data Management) of ink.data service includes the full integration of the Digital Pen & Paper technology with a sophisticated web-based system for the management of the clinical research (CTDMS) equipped with forms for data cleaning, queries, safety, data export, reporting, logistic-administrative tracking, etc.