Sometimes sponsors and CROs are not sure in the early stages of a trial that will include imaging whether or not they’ll need a central read. That is a huge unknown, one that can wreak havoc with budgets and planning. We at Keosys are sensitive to this and have designed our offerings to help address this problem. In fact, we have created a family of solutions.
Collect and Hold Services
When you work with us at Keosys, central reads can be added to your study at a later date—or not added at all, depending on how your study unfolds. The basis of this service is a “collect and hold” approach. That means that images can be centralized and reviewed for quality and completeness, but then held in that state. They are read-ready if a central review proves to be necessary.
We offer two levels of “collect and hold” services to meet a range of budgets and situations:
Collect and Hold - Silver Tier
This level of service is convenient for anyone running an early-phase clinical trial using internal image review. Image data is collected and centrally archived without a Quality Control (QC) check. In that state, the data are ready to transfer or review at a later date without delay or risk of loss. A single license to our Imagys online review platform is provided and central reads can be performed by you internally or by readers managed directly by your team.
The benefits include reduced costs and flexibility in how you use your data. However, since there is no QC or Imaging Acquisition Guidelines, you will not be able to generate regulatory-compliant data.
Collect, Collect, and Hold - Platinum Tier
Our Platinum Tier provides central collection and quality control of the data, but also includes imaging site qualification, training, and coordination for image acquisition and data transfer according to the Image Acquisition Guidelines developed for your study. We provide ongoing support and communication to assure the highest quality data. Images are quality controlled by one of our trained technicians to make sure sites are compliant with the Imaging Acquisition Guidelines.
This service is ideal for multi-site trials spanning global regions and/or studies with complex or multiple imaging endpoints that don’t require an initial central review but may lead to a regulatory submission. Image data are quality controlled by our pool of highly competent technicians and so are ready for regulatory review without further cleaning.
If your study requires central reviews, you should know that Keosys offers two options: Full reading service and Platinum Tier with optional reading services:
Collect, QC, Read, and Hold - Full Service
Our Full Service offering provides the most advanced approach to clinical trial imaging support and assures the highest quality image acquisition and central image review. This level of service is ideal for studies of any complexity that require a central review of data. At this level, we provide not only the highest quality data collection and transfer, but also the highest quality review thanks to our pool of physicians specialized in different therapeutic areas, plus upfront consultation and ongoing project management and communication. Ongoing project management, a communications plan, Image Acquisition Guidelines, reader training and monitoring, and an Image Review Charter ensure that your study proceeds without a hitch.
Platinum Tier with Optional Reading Services
If you are unsure about the timing or even the need for a central review, we can build an offer that is based on a Platinum level of service but also includes all the activities related to central reviews listed as options. Each option can be triggered when needed (e.g., writing of the Charter for an FDA meeting, selection and training of central readers only when local results seem promising, etc.) Adding a central read to an on-going project is easily managed at Keosys thanks to our internal development team.
How Can We Best Meet Your Needs?
Whether you require full-service support with imaging endpoint consultation, an Image Review Charter, Project Management, and Independent Centralized Review, or a simple collect and hold system, Keosys can ensure your needs are met on terms that work for you. Reach out to our sales team at email@example.com to find out more.