Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success. The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.
Globalization of clinical trials, tightening regulatory requirements, a more competitive and collaborative commercial environment, and an increasingly mobile workforce requires life-sciences companies to standardize and improve regulated content management processes to ensure information is shared with the right people at the right time.
Learn about the challenges for Sponsors and CROs when integrating a vast array of data sources, typical relational database structures and why they don’t work for clinical analytics, as well as the ideal clinical data aggregation solutions for continuous, automatic data consolidation.
The adoption of RBM is increasing as companies provide greater management support, staff training and more sophisticated technology systems. Technology platforms that enable continuous monitoring with near real-time intuitive visualizations, analytic dashboards and applications will allow issues to be identified and addressed early, improving study safety and efficiency.
Proponents of RBM projects believe that the investment in this approach will return an overall reduction in monitoring expense by 15 to 20 percent. This paper discusses RBM as a high-value use case that can be enhanced by a robust clinical data aggregation and analytics solution.
Drug developers are focusing significant attention on risk-based monitoring (RBM) of clinical trials to improve data quality, trial efficiency and patient safety. Widely encouraged by regulatory agencies, RBM adoption is gradually building momentum as sponsors and contract research organizations (CROs) concentrate on developing the right strategies, deploying the most effective technologies and internally managing change.
This article discusses ways to adopt patient-centered drug development, changing the corporate culture and trial design, understanding patient needs and incorporating them into trials, and leveraging technology to conduct remote patient-centric clinical trials.
RTSM software developed with an agile methodology and built on a modern technology stack dramatically accelerates the study start-up process and mid-stream adjustments. Customers are able to see and interact with the system before approving specifications and changes can be made quickly, without impacting study progress. The use of agile software in clinical trials enables customers to streamline internal processes and spend time on other high-value activities critical to the success of their studies.
There is a dazzling array of quality initiatives within the clinical trials sector all looking to move the needle from paper-based methods or single point solutions to a more integrated, non-siloed approach to study conduct. These efforts, may be rooted, at least somewhat, in work started nearly 20 years when the Institute of Medicine published To Err is Human, a call-to-action to improve safety in our healthcare system by linking it to greater quality. That seminal work was followed by various reports recognizing the urgent need to transform the clinical trials enterprise by focusing more intently on quality, which leads us to today’s sharp focus on this subject.
The sharpening focus on quality management is fueling greater use of standardized metrics to optimize clinical trial performance. Stakeholders are embracing this trend through growing adoption of cloud-based technologies, such as clinical trial management systems (CTMS), source data, and the electronic trial master file (eTMF). The information they generate is flowing into data analytic tools, and with this capability, standardized metrics are gaining mainstream status.
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