How long does it take to implement the QuartzBio® platform?
Typically, we deploy infrastructure to new clients and deliver production data in the UI within weeks from contracting
Can the QuartzBio platform be deployed if a study is already in progress?
Yes, we routinely deploy during ongoing studies.
To what data specifications must our vendors adhere, so that data can be uploaded to the QuartzBio platform?
We’ve purpose-built the QuartzBio platform with the recognition and deep appreciation for the complexity and inconsistency of data. Our platform is source system- and format-agnostic. We do not enforce rigid data specifications that require vendors to change how they provide data.
With this in mind, we can also integrate data for studies that have already been completed.
How does data get into the platform?
The most common way that we engage with vendors is being added as a third party to an existing data transfer agreement between the vendor and the sponsor. We also frequently receive data uploads directly to the platform from sponsor teams.
We have the capability to integrate with APIs, though vendors don’t always have them available. With our breadth of experience, teams are often pleased to learn that QuartzBio is already working with their vendors.
QuartzBio is also flexible and open to aligning with existing processes and capabilities that sponsors have in place.
Can the QuartzBio platform function across multiple studies?
Yes. Not only can the platform integrate data across multiple studies, but it can also integrate historical data and publicly available datasets.
The key to this capability is QuartzBio’s standardized data model, which encompasses a variety of data elements covering subject and sample metadata as well as the variety of assay technology-specific metadata and reportables. However, the data model is flexible and can be amended to incorporate various additional data elements based on sponsor needs. This is usually supported by QuartzBio’s Professional Services team during the setup phase in collaboration with the sponsor.
Is this system GDPR compliant? How about 21 CFR Part 11?
Yes, read more about our key security features and compliant infrastructure.
How often is data refreshed in the platform?
Data is refreshed on an ongoing basis as results data becomes available. Frequency is largely dependent on the needs of the client/sponsor.
The QuartzBio platform can be used to identify and address discrepancies; do you have to wait until the clinical database is locked to do this?
No, it’s not necessary to wait until database lock. With the vSIM solution, data are integrated continuously throughout the life of a study. This approach is designed to be implemented before database lock, and discrepancies are highlighted as data is refreshed.
When updates are made in the source system, the discrepancies will be automatically resolved in the platform. With this approach, everyone on the sponsor and CRO teams can work from a common single source of truth – and they can confirm that source systems are updated appropriately. This dramatically reduces the burden of tracking discrepancies.
Our central lab does sample reconciliation – how does this system fit in with that process?
Reconciliation efforts typically have large gaps for sample information that is critical for sponsor teams. These gaps are often related to central labs being focused on reconciling samples they receive back to the requisition form or EDC. Gaps in this process include the ability to report in a timely manner on missed collections, unexpected samples, and the status of samples and derivatives as they move onto third-party testing labs.
In order to create a holistic view of samples on-study, QuartzBio pulls information together from the EDC, and each lab and biorepository. We also incorporate the sample schedule from the protocol, including changes to the protocol as new patients are enrolled and as the protocol is amended.
We’re running a trial with (name of specific CRO) using (name of specific EDC). Are these data sources compatible with QuartzBio?
The answer is, universally, yes. Our team has deployed this solution on hundreds of studies, and this solution is not limited to a specific list of vendors. We have experience with inventory data from most of the active CROs, EDCs, central labs, and specialty vendors – this even includes data from academic labs, which can be particularly challenging.
Central to our approach is that our team and solutions are flexible. If your trial involves a vendor we haven’t worked with before, it is straightforward to set up a data ingestion pipeline for a new data source. This is a process that takes weeks, not years, so it can be deployed even on active studies.
