Are you part of a multicenter clinical trial? If not, you may be soon.
Multicenter trials, where a sponsor or CRO relies on a highly developed coordinating center to manage a network of sites, continue to gain popularity among sponsors looking to accelerate study timeline and reduce development costs.
This growth is in direct response to the rising complexity of conducting clinical research – now requiring more diverse patient populations across broader geographic regions. One key indicator of this shift is reflected in the rising number of Multicenter Investigator Initiated Studies – up over 155% in the last decade.
The Old Way of Managing Multicenter Studies Doesn’t Work in the Modern Era of Clinical Trials
Multicenter studies demand a higher volume of required documentation to track, analyze and submit data to sponsors and regulatory bodies. Coordinating centers running multicenter trials are under more pressure than ever to effectively streamline processes to reach project deadlines.
The compounded impact of rising trial complexity, up 352% in the last decade, and exponential growth of new clinical studies launched per year, up 300% over the same time, add significant strain to coordinating centers. Coordinating centers and their teams must now manage an ever-growing volume of documents, data, sites, and patients.
However, many centers rely on inefficient processes like email, paper, site visits, spreadsheets, and shared drives to manage their network of sites. These antiquated processes simply do not work in the era of the modern clinical trial.
Leading Coordinating Centers Create a Single Technology Ecosystem for Managing Multicenter Trials
Creating a single ecosystem to manage multicenter trials is the goal of any advanced coordinating center. By gaining a real-time view into study status, document completion, inspection readiness, and site operations across their network of sites, coordinating center teams streamline processes, accelerate timelines, and drive down costs.
Florence has pioneered a new reality for managing multicenter clinical trial studies by deploying a comprehensive site workspace, eTMF, and eISF in a single platform seamlessly connecting the coordinating center to each of their sites. In use by over 4,500 investigators today, including many of the largest site networks in America, Florence eTMF + eBinders simplifies the complex process of managing a broad group of research sites from a central location.
How does this happen with Florence?
1. Advanced Access and Permission Controls.
A single digital ecosystem harnessing role-specific controls ensure that each site participating in the study only sees the information they are authorized to view. This allows for the coordinating center to manage studies within the same platform as participating sites.
2. Standardized Binder Setup.
In order to easily manage file organization and study start-up, standardizing binder setup across participating sites enables efficient navigation and reduced study timeline through simplistic repeatable processes. These processes can be used again and again across multiple future studies. through standardization across participating sites
3. Simple Binder and Document Template Sharing.
Centralized documents can be easily distributed as templates with fillable fields to all sites online. Documentation and form task completion can be managed through notifications and project dashboard overviews.
4. Quality Control Workflows.
Centralized overview and collaboration is made easy before approving key documents by allowing robust workflows to track study progress and encourage task completion.
5. Easy Site Oversight Tools.
Real-time study insight is available across all trial sites through global study dashboards and reports. Depending on role permissions, members of a site or coordinating center can easily track trial progress to make informed decisions.
6. Intuitive Site Workspace.
A user-friendly platform that is available anywhere, anytime, and on any device. Ease-of-use is the main pillar that is built into every feature of the Florence platform.
As multicenter trials continue to gain momentum, it is essential Coordinating Centers have a technology backbone in place to support the rising complexity and growing demand of managing these trials.