Cybersecurity: Critical in Clínical Trials In recent years, the number of cyberattacks has increased due to the proliferation of viruses, malware, and new and increasingly sophisticated techniques. Therefore, all companies face risks that endanger their systems and can leave confidential information exposed. Still, unfortunately, not all organizations are aware of the risk they face, which… Continue reading Importance of Pentesting in Software used in Clinical Studies
Computer System Validation is a premise for Integra IT to ensure that data and solutions are reliable; validating all of our solutions is one of our core activities and our central quality promise. Since 2002, the FDA has stated the General Principles of Software Validation, guidelines applicable to medical device software validation. The main goal… Continue reading Computer System Validation (CSV) in Clinical Trials
Integra IT understands and has the solution to an issue commonly faced by healthcare systems and clinical trials around the world: interoperability. Seamless integration between information systems in healthcare and clinical research must solve two problems; first, technical interoperability, which means that systems can reliably transfer data between them, and second, semantic interoperability, in which… Continue reading Achieving Interoperability between clinical trials software
An efficient clinical trial of the polio vaccine was critical for the emergency approval of the sponsor vaccine against the second wild strain. Then, solve the delicate health situation in Africa due to the high number of children infected with a variant that was thought to have been eliminated, but that increased again after the… Continue reading Efficient Clinical Trial of the Polio Vaccine Against the Second Wild Strain, Vital for Children in Africa
According to the American Agency for Healthcare Research and Quality (AHRQ), Electronic Medical Records EMR system is defined as “an electronic record of health-related information on an individual that can be created, gathered, managed, and consulted by authorized clinicians and staff within one health care organization”(1). An EMR contains the medical and treatment history of… Continue reading The Electronic Medical Record (EMR) Relevance in Clinical Research
Cevaxin, a research Site located in Panama, used TrialPal to achieve an outstanding eDiary reporting compliance rate in a Phase I vaccine clinical trial with older adults. While developing clinical trials, research sites usually face common challenges, such as technology adoption regarding participant reporting and timely monitoring. Understanding this and the particularities of the vaccine… Continue reading How to achieve a 98% eDiary reporting compliance rate in older adults with TrialPal
COVID-19 studies in healthcare workers in University of Mainz Integra IT had the opportunity to participate and contribute with its tools in observational COVID-19 studies conducted by the University of Mainz on COVID-19 and its impact on healthcare workers. It was the first project of developed Integra IT in Germany. The project collected data on… Continue reading COVID-19 studies in healthcare workers – University of Mainz
Integra IT software solutions has been essential for developing the Fiocruz vaccine Phase 3 trial for SARS-CoV-2 in Brazil, achieving efficiency in data collection and organization. This project collected information from 10,000 volunteers for a year, managing their data via Integra IT’s TrialPal and PFS tools. The project was carried out in Brazil, a… Continue reading Integra IT, part of the Fiocruz COVID-19 vaccine trial in Brazil
The decentralized model proposes the performance of clinical trials as partially or entirely remote. The main activities of the trial can be driven through technology and require fewer site visits and more remote monitoring. These approach guarantees trial quality and data integrity in the same way as traditional trials, and it has broadened access to… Continue reading What are Decentralized Clinical Trials and their Impact on Vaccines?
Data move us! Our eCRF & Data Management Services gives clinical trials a broad and precise operations control under one integrated platform. We have vast experience with data processing, cleanning and accuracy. Among others, recently we outstand in performance during a COVID-19 Real World Evidence Study (RWE) in Latin America, thanks to our robust capabilities.
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