e-FORM

The concept of a "one-stop solution" for e-FORM, stems from the integration of various modules that cover different phases and aspects of clinical trial management. The idea that e-FORM is a "one-stop solution" is supported by its described characteristics and the typical modules of a clinical trial management platform. The integration of these modules reduces the need to rely on different platforms, simplifies the management of clinical trials, and optimizes costs and times, as highlighted in the advantages of e-FORM. The system's ability to handle data collection, management and transmission, along with its e-Monitoring and ability to generate definitive databases for statistics all further demonstrate its comprehensive nature.

e-CRF (Remote Data Capture)

This module is fundamental for the collection, management, and transmission of clinical trial data via the Internet (e-CRF). It is the basis upon which the management of clinical data in electronic format is built, eliminating the need for paper forms and speeding up the process. The centralization of data collection in a single system is a crucial element of the "one-stop" concept.

e-LAB (Laboratories w/ normal ranges)

It allows for the management of data from laboratories, including reference values, facilitating the interpretation of results and the identification of any anomalies. The integration of laboratory data within the platform simplifies the overall management of clinical trials.

e-MON (Remote Monitoring)

It allows for electronic monitoring of clinical trials, reducing the need for on-site visits and associated costs. This module is a key element in reducing the time and costs of studies.

e-RPT (Standard & Ad Hoc Reporting)

A reporting module is essential to generate standard and ad hoc reports necessary for the management of clinical trials and for the presentation of results.

e-DRUG (Drug with randomization)

This module is crucial for clinical trials involving drugs, allows for the management of patient randomization and information related to the study drugs. The integration of drug management within the system increases the efficiency and accuracy of the trial.

e-DICT (MedDRA, ATC, custom dictionary)

The integration of a standardized medical dictionary, such as MedDRA or ATC, allows for uniform data coding and facilitates the analysis and comparison of results. The presence of a customizable dictionary is also important to adapt the system to specific needs.

e-STATS (Real-time Statistics)

This module would allow for the real-time visualization of statistics related to the study, providing researchers and trial managers with an immediate view of the ongoing data.

e-SDV (Source Data Verification)

This module facilitates the verification of source data, a fundamental process to ensure the quality and reliability of the collected data.

e-SITE (Site Initiation, Periodic Monitoring, Close-Out)

This module supports the management of the activities of the trial sites, from the initiation phase to the closing, ensuring efficient coordination.

e-TICKET (Help desk ticketing)

A help desk module allows for the management of requests for technical support and reports from users, ensuring efficient and timely support.

e-SAE (Serious Adverse Event Report Form)

The management of reports of serious adverse events is crucial for the safety of participants. This module would allow for efficient management of SAE reports.

e-ICF (Informed Consent Form)

The management of informed consent is essential in every clinical trial. This module would allow for the digitalization and management of informed consent forms directly from patients, facilitating access and traceability of documents. >>>

e-PRO (Patient-Reported Outcome)

This module allows for the collection of data directly from patients, through electronic questionnaires. This functionality facilitates the collection of data related to patient experience, providing valuable information for the evaluation of outcomes. >>>

e-TMF (Trial Master File)

The Trial Master File is an archive of crucial documents for the clinical study. This module would allow for the electronic management of the TMF, facilitating access, research, and regulatory compliance. >>>

e-DOC (Document Management)

An integrated document management system is essential to centralize and manage all documents related to the clinical study. This allows for efficient document management and ensures regulatory compliance. >>>