Patient Follow Up System Site CTMS
This is an intuitive and easy-to-use tool that allows monitoring of study participants and the study in general.
It is a configurable platform, in order to meet the needs of the project to the maximum, allowing the activation of the different modules and functions according to requirements.
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Patient Follow up System
PFS is a web system developed in order to collect information from clinical trials. Therefore it is the application where all the information collected by our Trial Pal is centralized.
PFS Product is a specialized software based on highly reliable and available platforms that guarantees an excellent service performance without interruptions, integrating security standards, and guideliness such as CFR Part 11 from the FDA. This system is designed mainly for the Sites and will allow efficient management of subjects and the trial.
Through PFS, a Site can manage interactively and in real time, all the information of the subjects, including receiving email alerts indicating any important event for the study. Likewise, it is a key aspect for maintaining high adherence of patients during the study since it has detailed tracking information such as: what subjects have not reported, what the last visit made was and by whom, when the next visit, next call is, etc.
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This is where all patient information is stored (contact information, parent information, subject number, etc). All information collected is handled with roles, and profiles that will have access according to their privileges, to see more or less detail of subjects; always guaranteeing the confidentiality and integrity of information.
Subject Log Module
This module presents a very simple-to-use functionality that records all the contacts a site has had with the study subjects. Thus, a consolidated tracking log for each subject. Team members know who the last person was to contact the subject and when this happened.
This module helps to manage the laboratory samples generated during the study such as stool and blood samples. The Site can configure different states that these samples can be in, and each of them is used to create a form that contains information about the state, including changes. It also helps manage the location where samples are stored.
We have developed an interface with CDC laboratory systems for more efficient communication between study sites and CDC.
This module allows control of the subject visit agenda. It presents a calendar view to show all study visits. The main feature is that this module helps sites to calculate study visit windows, including holiday management, for accurate and real planning.
This module allows mass uploading of information from different sources of potential subjects for a new study. It also allows the scheduling of initial study visits. Once a candidate has passed all the enrollment process, they can be promoted to subject / patient within the system.
The activities module allows the user to complete and/or monitor the progress of the various activities associated with a subject that is participating in a project or clinical trial. Within the module, site staff can perform the following actions: Start Activities; List Activities; Assign Activities; View Statistics; Download Activity Reports; Perform Activities.
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Hospital la Maternidad
Dr Lourdes Peña tells us a little bit about the experience of having PFS II in the Hospital, helping it to better organize the entire study, as well as communicate with the patients.