The Food and Drug Omnibus Reform Act of 2022 (FDORA) was signed into law, amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. It includes provisions that impact various aspects of the FDA-regulated industry. Some key provisions include reauthorizations of FDA programs, reporting requirements for approved biological products, improvements in… Continue reading Implications of The Food and Drug Omnibus Reform Act of 2022 (FDORA) for the clinical trial industry
From the ideation of the scientific question, sponsors can consider integrating ePRO tools in protocol designs. Decentralized and hybrid clinical trials can widen the data points and make the most of each trial. Here we share five steps to introduce an ePRO into a protocol: Define the objectives an ePRO tool can address: Identify the… Continue reading How to include an ePRO in your protocol design
We are pleased to announce that we have recently iniciate a significant partnership as technology providers for the CHRISTUS LATAM Clinical Research Center, a research center located in Nuevo León, Mexico, that offers clinical research solutions for the pharmaceutical industry and seeks to provide more treatment options and modern medicines to the Mexican population. … Continue reading CHRISTUS – LATAM and Integra IT Announce Partnership
Clinical trials are essential to advancing medical science and providing patients with novel treatments. The optimization of clinical trial operations depends critically on effective data management and adherence to CDISC guidelines. Clinical data management is the systematic gathering, organizing, validation, and analysis of data produced during clinical trials and healthcare research activities. (1) Clinical… Continue reading What is Clinical Data Management?
Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient Reported Outcomes (ePRO) are two types of electronic data collection methods. While they may seem similar, there are some differences between them that are important to acknowledge. ePRO involves patients reporting their own health outcomes directly to their healthcare provider or research team. This is usually… Continue reading Differences and similarities between an eCOA and ePRO
As the demand for efficient and streamlined data management in clinical trials continues to grow, with numerous vendors offering a wide range of features and capabilities, selecting the ideal EDC solution could be difficult. So, how to choose the right eCRF provider? Here we share insights about some technology selection criteria that Sponsors and CROs… Continue reading How to choose the right eCRF?
Daily site operations and visit scheduling are often a burden for clinical research teams, who constantly seek to engage and build long-term relationships with participants. Dealing with tight deadlines, extensive planning, and assessments are tasks that impact the point-of-care services and staff workload. A software tool like Trial360, which includes an integrated scheduling system, can… Continue reading Scheduling at Research Sites: From a Problem to an Opportunity
Integra IT has developed reliable eCRF software solution and Data management services priced to fit your budget and excels in delivery, quality, support, and time. The data is the most valuable asset of a clinical trial. Ensuring data quality and accuracy determines getting the necessary evidence to accelerate the route to market. We disrupt the… Continue reading 6 eCRF software & Data Management Services Capabilities by Integra IT
An FDA 2020 report (1) has shown a 28% decrease in underrepresented populations in United States clinical trials compared to 2018. Moreover, the 2022 FDA guidance for the industry to improve underrepresented racial and ethnic participants’ enrollment is a call to action to get clinical data that really reflects the diversity of the population expected… Continue reading Rising Equity in Clinical Trials and Emerging Countries Through Tech
Last week we joined the Clinical Research Insider Summit in Cancun, Mexico. This was Integra It’s first time participating in this event, endorsed by the School of Medicine and Health Sciences of Monterrey Tech. As part of our strategy of bringing more visibility to clinical trials in emerging markets, we wanted to explore the future… Continue reading Event recap: Highlights from Clinical Research Insider Summit 2023
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