Frequently Asked Questions

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Technology

Is our Electronic Health Record (EHR) system suitable for automating data collection?

If you are running a recent version of Epic, Cerner, InterSystems, or one of the other major vendors supporting ‘SMART on FHIR’ / HL7 FHIR APIs, then most likely yes.

What is FHIR?

HL7 FHIR is a universal standard for healthcare data systems. (It is now a requirement that all EHR systems developed in the US use HL7 FHIR, and incorporate SMART on FHIR application programming interfaces (APIs) that allow them to interface with other systems.)

What is SMART on FHIR

SMART on FHIRis an Application Programming Interface (API). It provides a conduit that allows us to securely ‘plug in’ one system to another, accessing data on-demand.

Archer

We have not used FHIR before, is it worth the effort?

100% yes! HL7 FHIR is seen as the future for general interoperability between internal system, so this is future proofing the hospital.

Once you have concept mapped your data to FHIR resources, you will be in a position to develop your own add-on apps to the EHR or purchase other applications now available.

We do not receive primary-care data. Will this be an issue?

This isn’t usually a concern. Many research departments input the medication history into systems such as Epic and Cerner, at patient visits during the study. Providing this has been entered and coded correctly, Archer will pick it up from the FHIR feeds. Our technical support teams can help you review this during the setup process.

Do we retain control of our data if we use Archer?

The site investigator is always in control of the data. Regulatory-grade data is securely transferred to the EDC via the cloud and no data is retained within Archer.

Which sponsors are using Archer?

Archer integrates with all leading study databases, for example, Rave, Castor and Cisiv. IgniteData’s Archer technology is actively being used or integrated with some of the largest sponsors and CROs in the world.

How much time will Archer save me on data entry?

Analysis of a live study indicated that using Archer automation in place of manual data entry yields a 96%-time saving per patient visit.

How does Archer work?

Archer’s cloud-based technology embeds directly into your EHR: it transports regulatory-grade, clinically-validated patient data from leading hospital Electronic Health Record systems (EHRs) to sponsors’ Electronic Data Capture systems (EDCs) using HL7® FHIR®-based APIs.

General

How can I get news about IgniteData and Archer?

Keeping up-to-date with IgniteData is easy. Use the sign up box at the bottom of this page to receive our news and blog. If you would like to ask our expert team a question, please contact us

Who founded IgniteData?

The founders of IgniteData are Dan Hydes, our CEO, and CTO Richard Yeatman.

When was IgniteData established?

IgniteData was formed in 2014 with the aim of helping deliver modern clinical trials; the concept of a cloud-based system that would allow for the interoperability of these siloed healthcare data systems was already embedded in our thinking.

Where is IgniteData based?

Our offices: IgniteData Inc.,1209 Orange St, Wilmington, New Castle, Delaware, 19801 US. Ignite Data Limited UK is a fully-owned subsidiary of IgniteData Inc.

Security

What are your data privacy standards?

IgniteData does not store any data. No on-prem or separate cloud deployments are leveraged. All data is hosted in the Archer cloud tenant and destroyed following successful transfer to sponsor.

How has the AI modeling validated?

We own the full logic and audit trail of our model. IgniteData can confirm what, why, and where data was discovered within the full clinical trial data set.

How accurate is the AI modeling?
  • Precision – 100%
  • Recall – 100%
  • Accuracy – 100%

Tech & Functionality

What happens if required data is not exact or available in the data set?

The model will not make a prediction if there isn’t a clear data entry. In these cases, it will alert the CRC so they can determine what the correct submission should be.

Example: If clinician’s note states “ECOG varies between 1-2”, the CRC will receive an alert to extract the correct ECOG for submission.