Cevaxin Clinical Trials are carried out in cities such as La Chorrera y David and the township of 24 de Diciembre, a division of the district of Panama. In these areas, we are working with the middle and low social strata populations in the norovirus, dengue, chikungunya, zika, and respiratory syncytial virus studies.
The Integra IT solution is in line with the level of information organization that Cevaxin requires since it has participants from whom it requires specific data because it deals with populations such as newborns, pregnant mothers, adolescents, and adults.
What projects does Cevaxin have?
To understand what kind of information we are dealing with, let's take a look at some projects at the Panamanian network of sites.
Cevaxin is working on an epidemiological study with children under two years of age to detect and follow up episodes of acute gastroenteritis (AGE).
Two other projects, with participants between the ages of 4 and 16, investigate dengue vaccines’ efficacy, safety, and other variables.
Another project aims to determine the safety and immunogenicity of the Chikungunya virus (CHIK) vaccine in healthy volunteers of both sexes under 18 years of age.
Part of another epidemiological study at Cevaxin is the pregnant women between 24 and 27 weeks of gestation, with the intent to describe pregnancy outcomes and events of interest in the mother and newborn and the incidence of respiratory syncytial virus and respiratory tract infection in infants.
One of the studies is designed to evaluate the impact of early interception and intervention on antiviral activity and the clinical course of the disease. Eight hundred infants, including 40 RSV-positive infants, are participating.
Finally, there are three studies with different variables, all aimed at testing RSV vaccines, one for infants and one for pregnant mothers.
The Integra IT contributions
Integra IT solutions improve Cevaxin processes avoiding bottlenecks, reducing costs, improving analysis, end-to-end visibility, security, and quality under GCP regulations enhance its overall competitive advantage in the market.
The most appropriate solutions are those that generate significant contributions to core activities. Beyond the recording of symptoms, clinical visits, and patient follow-up, the added values provided by IntegraIT are necessary, such as the recording and real-time tools available for decision making.
It is also essential to know what a research center like Cevaxin can do with the real-time collected information. Integra IT provides statistics, KPIs, and the availability of additional information that can identify weaknesses in processes to fix them. The investment in these tools is reflected in cost reduction, ease of analysis, and increased productivity.
The solution offered by Integra IT, contains differentiating factors, providing tracking and study protocol definition and easy setup. The investigators can access the information collected easily, simply, optimally, and intuitively.
In addition, Integra IT generate alerts and notifications, which are essential for making decisions at the right time.
What is PFS and how does it work?
Integra IT provides a suite of tools. The following is a brief description of the module included in the Patient Follow-up System (PFS). You can have a high-level overview of how they work and help collect information according to the project.
Scheduling
It is used to schedule visits to participants. It has a calendar to have an agenda or calendar to avoid, for example, overlapping appointments and meet visits windows according to protocol definitions.
Activities
It works for automatic scheduling of activities, such as periodic reminder calls to follow up on the health status of the participants.
If any of them, for example, reports an altered state of health, the activity is created so that the physician can follow up on it.
Vigilant-e (Surveillance reports) and e-diary card
Allows the view of different reports from the PFS. The information can be filtered and downloaded for detailed analysis, and when a symptom is detected, alerts can be created and sent to the e-mails of the users involved.
Reports
PFS allows downloading of information from the lists in easy-to-read formats. PFS allows downloading of information from the lists in easy-to-read formats.
Laboratory Sample Tracking
This is an option to manage laboratory samples and know their classification according to type, origin, study, patient, etc., via a list.
House Hold
This function allows grouping family members and identifying them with a household number. This is so that when activities must be done per subject, such as telephone calls, it is not necessary to contact each person individually. Still, with only one contact, it is possible to track all the group members.
Results for Cevaxin
Cevaxin reduced out of window visits, protocol deviations, and dropout rates while improving the subject's recruitment process.
With lab samples reports entered into the Patient Follow System, it has been possible to have organization and follow-up at the fingertips of the scientists. The real-time digitalization of this information allows access in an agile and timely manner for the interests of Cevaxin.
It has been possible to obtain information via the PFS delivered by Integra IT respecting two fundamental principles, security and transparency, thanks to the recording of symptoms collected directly by subjects. When a person performs the data collection from the site, it is achieved through a direct call or a face-to-face consultation and then registered in the PFS system.
Sending reports is an added value provided to the client, which defines the frequency of sending specific information to improve workflows and operational processes. For example, when key performance indicators show low participation in the reporting symptoms, an alert is created to contact subjects involved and send a reminder message. Therefore adherence increases.
Finally, concerning laboratory sample cases, if the PFS indicates that there are stagnant and unanalyzed samples, measures are suggested to re-stabilize the operation chain and resume optimal workflow.
Learnings thanks to Integra IT tools
- Cost reduction and better cost utilization
- Ability to devise new ways of working to optimize the study
- It improves processes thanks to technology
- It guarantees the security of the information
- It allows focusing efforts on more critical issues
- It reduces workload
