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 is… Continue reading Importance of Pentesting in Software used in Clinical Studies
For Integra IT, it is a premise ensuring 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 of Integra IT,… Continue reading Computer System Validation (CSV)
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
COVID-19 studies in healthcare workers in University of Mainz Integra IT had the opportunity to participate and contribute with its tools in the observational study 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
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. This 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?