In the 21 CFR Part 11, the FDA established guidelines for electronic records and electronic signatures. A fundamental aspect of compliance in clinical trials is maintaining a secure and comprehensive audit trail for all actions performed within the system in which a study is being conducted. Here we share the key requirements you must have… Continue reading What are the requirements of Audit Trail in CFR 21 Part 11?
Remote monitoring of clinical trials in Trial 360: Innovation for a More Efficient and Safe Future Clinical trials are vital in developing and approving new drugs, treatments, and medical devices. The regulation requires monitoring of clinical trials to ensure the accuracy and reliability of the data generated by the trial. Monitoring includes reviewing data and… Continue reading Remote monitoring of clinical trials in Trial 360
Research sites face a critical challenge that has an effect on their sustainability and overall performance: invoicing and financial management. It is common for sites either to lack a specialized billing system or to have one that is not connected to their day-to-day activities. The billing method vary according to the type of contract,… Continue reading Financial Management in Research Sites: Key to Sustainability
Scheduling at research sites is not as straightforward as in other clinical services. Commonly, patient visits must be scheduled according to a research protocol and their compliance is essential for the success of the study. Using an intelligent scheduling system can bring great advantages to the research team, among them: Reduction of protocol deviations Thanks… Continue reading Scheduling in Research Sites (4 Key Benefits).
Over the years, migration trends have changed, and the United States still has the highest rates of immigrants globally. This reality has impacted public health and healthcare access, demanding legislation and policies such as providing prenatal care to women regarding their immigrant status, which has been adopted in 18 states (1). On the other hand,… Continue reading Hispanic Community In Clinical Trials. Tech Role.
Delegation Log in Clinical Trials Trial360 delegation log is a vital tool for research sites. It serves several crucial purposes, ensuring compliance, accountability, and efficient study conduct.Get enhanced accountability by clearly assigning tasks and responsibilities, ensuring everyone is aware of their specific roles. This helps identify any potential issues with task execution. Additionally, with a… Continue reading A Compliant and Easy to Setup Delegation Log with Trial360
Around this season, many research sites are planning and projecting their budget for the upcoming year 2024; this is an excellent opportunity to consider a key investment in technology and data-driven management that will bring efficiencies and savings in the short, medium, and long term. By implementing Trial360, sites can go paperless, as well… Continue reading Are you planning your site’s 2024 budget?
Trial360 new enhanced PI – QA – Data entry Oversight Feature The new and improved quality review functionality within Trial360 seamlessly integrates quality assessments directly into the visit process. Effortlessly capture review details, including date, time, reviewer name and role, responsible party, a description field, and the option to link findings and deviations to the… Continue reading Streamlined Quality Reviews with Trial 360
We chose Odoo business suite (ERP, CRM, etc) as the foundation for Trial 360 because it offers the robustness, security, flexibility, experience, and scalability that every company needs. Clinical Research Centers lack a unique platform to conduct clinical trials, business, and administrative and finance processes. Odoo’s proven track record in other industries and adaptability allowed… Continue reading Why is Trial 360 based on Odoo Business Suite?
Recently, we participated in the global meeting of research centers of the Society for Clinical Research Sites – SCRS in Hollywood – Florida. Today, we want to share with you some topics that we identified and will be important for the clinical research industry for research sites. Participant-centered care: A participant-centered and needs-based approach will… Continue reading Trends and Insights for Research Sites in 2024
