In recent years, sites have increasingly invested in technology to eliminate paper records and reduce workloads related to inputting data, scanning, and transcription. Even though they can get huge advantages such as accelerated timelines and workflows, concerns like interoperability, adoption, and staff education remain. Sites can get advantages of tools like structured EMR data to… Continue reading Seven Opportunities for Non-digitalized Sites in 2023
Investigator-Initiated Studies (IIS) are studies where an individual investigator, a research site, or a group of research sites carry out the research from the protocol design until regulatory submission. This means they perform both roles, as a sponsor and as an investigator. This type of clinical research also has been known as investigator-initiated trials, independent… Continue reading Investigator-Initiated Studies, IIS: An Opportunity for Research Sites
ePRO/eCOA Capabilities to better conduct Clinical Studies ePRO/eCOA tools have revolutionized the clinical research industry. The first concept was raised a decade ago, but the idea of integrations between systems or interoperability was far from easy. In the past three years, the industry has experienced a boom of new technology development, broadening the data source… Continue reading Seven ePRO/eCOA Capabilities to Better Conduct Clinical Studies in Latin America
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
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