Rave EDC doesn’t require downtime during a protocol amendment. Medidata continuously improves Rave EDC to meet the flexibility challenges of modern clinical trials. Medidata Rave EDC Supports the Next Era of Clinical Data Management They also require the power and flexibility to accommodate multiple treatment arms and the mid-study changes inherent in adaptive trial designs. EDC systems for these decentralized studies must integrate data from telemedicine platforms, wearables, sensors, and other sources. Because of site closures, travel restrictions, and patients’ reluctance to visit a medical facility, use of remote visits in clinical trials accelerated in 20. As sponsors adopt a wider variety of complex clinical trial designs, their EDC systems must have the ability to implement complex changes-often midstream.ĭuring the COVID-19 pandemic, telehealth visits rapidly became a viable and necessary alternative to in-person appointments. There are also different forms of trials, such as basket, umbrella, and platform-each requiring a flexible EDC system. For example, adaptive trials change over time, which means that an EDC system must accommodate every possible pathway the trial will take. The complexity of clinical trial design is growing. As part of that infrastructure, there should also be a clear system to train or retrain users on any added functionality. These types of notifications are simple but effective mechanisms that should be standard within EDC systems. Otherwise, clinical research coordinators may miss that a new item has been added to their workflow. If a new field is added to a form, the user interface should clearly indicate that the new field needs to be completed. However, amendments that codify clinical trial data collection must be clearly identified for users to guarantee that each change is adopted throughout the trial. 1 Given the common nature of amendments, EDC systems should be designed to maintain normal operations while accommodating changes. This means an EDC system could need to be shut down multiple times, which is highly disruptive and inefficient. The Tufts CSDD study reported that clinical studies average 2.2 to 2.3 amendments per protocol. Modern EDC Systems Must Accommodate Protocol Amendmentsĭata collection and patient visit schedules are disrupted if a protocol amendment requires EDC system changes that can’t be made without taking the EDC system out of operation. Changes in study protocols create major logistical headaches for all involved and cost a significant amount of time-especially when it comes to clinical trial data collection. For example, sites may need to re-consent a patient if a change impacts how treatment will be delivered or how and what data will be captured. 1 Those amendments can disrupt sites and study teams, creating obstacles to efficiency. Proactive risk mitigation for research data quality issues to help prevent trial delays.Įmpowering a risk-based approach to source data verification by focusing on critical data.Ī cloud-based remote site access and monitoring solution.Īt least one protocol amendment occurs in over half of all clinical trials according to Tufts Center for the Study of Drug Development (Tufts CSDD) research. Quickly and accurately develop investigator grant budgets.Ī dynamic digital solution for risk assessment, monitoring, and mitigation.Ī powerful data & risk surveillance tool to improve data integrity & reduce trial risk. Unify your clinical research study data and financial management in one platform. Manage electronic trial master file content while maintaining readiness & compliance. Improve speed and efficiency for the oversight of studies with Rave CTMS (Clinical Trial Management System). Seamlessly generate, distribute, & manage clinical study files at the end of a study.ĭrive faster timelines across the trial lifecycle with centralized data & analytics.Ī streamlined, single digital endpoint adjudication system. RTSM (Randomization and Trial Supply Management)Įliminate double data entry and change orders for randomization and trial supply management.Īutomate collection, transmission and tracking of adverse event data.Simplify complex data investigation and cleaning across many data sources. Gain visibility and full control over your imaging data while simplifying processes for sites, sponsors, and core labs. The evolution in automated medical coding for Rave EDC. Eliminate complex, manual processes & achieve higher quality data for faster insights.Ĭapture and manage your patient, site and lab in the most advanced, robust and secure electronic data capture system.Įquip your clinical trial study with fast, accurate medical coding.
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