Over the last decade or more, the case has been made for electronic health record-to-electronic data capture (EHR-to-EDC) technology solutions to help solve the challenges of site-to-sponsor data transfer. We’ve been beating that drum for a number of years ourselves, and we’re pleased to see a new level of enthusiasm for the benefits that can be brought to sites, sponsors and patients.
The market for EHR-to-EDC technology is growing, and developments are fast-moving. But not all solutions are made equal, and it can be tricky to assess the potential for emerging solutions to address the pain points in clinical trials.
So, what are some of the points to look out for if you’re considering implementing a solution to support EHR-to-EDC data transfer and comparing options?
Pitfalls and drawbacks of some available solutions
Tied to a particular EDC or EHR
There are very few solutions built specifically to ease the challenges of EHR-to-EDC (or eSource to sponsor) data transfer. Of those that are on the market, a number are built by – or for – a specific EHR or EDC system.
As clinical trials become larger, more diverse and more dispersed, being tied to one system is a huge drawback. ‘Multi-site’ often means ‘multi-EHR’, so from a sponsor’s perspective, a solution built with one EHR in mind won’t match needs. Similarly, for sites looking to implement solutions, it’s essential to consider the different systems used by trial sponsors. Keeping in mind that sites work with multiple sponsors at any given time, and the governance processes needed to approve any solution used, single-EDC solutions are of limited benefit to trial sites.
Not a major step forward, compared to manual methods
The effort of identifying and transferring data from EHR to EDC has long been a pain point for clinical trials. We’ve talked about the inefficiencies and laborious processes involved many times. To this day, research coordinators spend thousands of hours searching through EHR data, manually transcribing, checking and correcting transcription errors.
Some of the EHR-to-EDC solutions currently being developed take a small step towards progress, by providing a window into EHR data, and facilitating a quicker ‘copy and paste’ process for transferring data. In our view, this isn’t close to the progress that trial sites and sponsors want and deserve to see, for two key reasons:
Time savings are limited
There are many more valuable ways research coordinators’ time can be spent, aside from trawling through EHR data. To see a noticeable improvement in the speed and costs of clinical trial execution, job satisfaction for staff, and quality of clinical trial data, we need to go further than providing a window into the EHR or EDC. We should – and can – take this burden away entirely (more on this later).
Lack of accuracy in identifying and transferring data
The complexities of transferring clinical trial data go beyond ‘click and drag’. Data in an EHR will often be stored in a different format to that needed by a clinical trial sponsor. Site and sponsor may use different ontologies, terminologies or coding systems, different units of measure or other conventions. Multiply this by adding in variations between different departments and multiple sites involved in a study. Without carefully mapping one system to another, there is a high risk of errors and inaccuracies in data being brought into a clinical trial.
Academic focus and/or lack of regulatory compliance
There is a difference between an academic clinical study and a commercial clinical trial. In particular, commercial clinical trials, funded by sponsor pharmaceutical or biotech companies, are focused on bringing new solutions to market. This means they necessarily have a high regulatory burden, and compliance is absolutely critical.
There are a few solutions on the market that are particularly suitable for academic studies, but any data solution that’s intended for use in commercial clinical trials needs to have regulatory compliance at its heart.
Data sharing agreements; FDA, HIPAA and GDPR compliance; regulatory-grade data; and complete transparency about the methods for accessing and transferring data are essential.
Archer: Transforming eSource to sponsor data
Archer is the solution that rethinks eSource to sponsor data transfer. Where some solutions skirt around the edges, Archer is an enterprise-level solution that takes a major leap forward. The sophisticated mapping engine maps fields from EHR to sponsor EDC or alternative final destination. This completely removes the burden of searching for structured data in the EHR and is rapidly delivering solutions for unstructured data.
No added burden for sites
Archer’s powerful mapping capabilities, combined with IgniteData’s expert team, mean mapping isn’t burdensome for trial sites and only gets easier. Our team completes configurations using information on fields in the source and destination systems, and site and sponsor teams review and sign off the settings. The whole process can be completed in a matter of hours, with very little effort from sites and sponsors. What’s more, this process is simpler and quicker with each new trial, as Archer’s mapping system learns from previous mappings between the same site and sponsor.
Transformational time savings
Archer eliminates the need to shift between systems, search for data, manually transcribe, and correct transcription errors. Researchers simply launch Archer, select the patient and study to review the relevant data available, then hit export to transfer clinically validated data to the study database.
The entire clinician workflow involved in transferring vital signs, labs and conmeds data from a visit can be completed in well under two minutes. This includes enrolling the patient in the trial, and retrieving, reviewing and exporting data in three separate forms. The investigator can choose to spend as much extra time as they wish reviewing the data before export, but this streamlined process means all the other time-consuming work of transferring and correcting data is taken off their hands.
Accurate, validated data
Using data direct from the source, validated mappings and transformations that ensure data is in the correct format leads to 100% accurate data. In a study with AstraZeneca and University College London Hospitals NHS Foundation Trust, Archer mapped 100% of vital signs and labs data, and was able to successfully transfer 100% of mapped data from these domains.
Because the data transferred by Archer exactly matches the data in the EHR, time spent on data queries and corrections is significantly less, and the requirement for Source Data Verification is reduced.
Researchers retain control
Archer is not a black box of data. As well as control over the validation of mappings, researchers retain complete control over the data being exported from EHR to sponsor. Archer displays the data retrieved from the EHR, mirroring the presentation of data in the EDC, and researchers confirm the export. Archer takes all the hard work out of the process, while allowing researchers to retain complete control and oversight of data being transferred.
Archer records audit logs with the complete chain of custody of data, so every item of data can be traced back to its original source, and any transformations applied can be tracked for regulatory audits.
Because data fields are carefully mapped and validated, then approved for export, there is no danger of Archer accidentally transferring personal information. What’s more, the methods of transferring data are all laid out in comprehensive data sharing agreements, covering how data is processed, stored and encrypted at the start of a study. Finalising these agreements can constitute a significant checkpoint when preparing to go live with electronic data transfer for a study. And rightly so. IgniteData takes the responsibility of dealing with clinical patient data seriously, and compliance and due diligence are integral to our processes.
EHR and EDC agnostic
IgniteData is independent of any EHR, EDC or other system vendor, and we designed and developed Archer to be completely system-agnostic. It works with all major EHRs, all major EDCs, or no EDC at all. This means multi-site trials are easily managed, and sites can use one solution for all their trial sponsors. Sites and sponsors can be free to choose and change the systems they use without causing any issues for Archer.
Because it is system-agnostic, built on a robust infrastructure, and learns from previous data mappings, Archer is highly scalable. That’s one of the reasons why Memorial Sloan Kettering Cancer Center, one of the world’s largest cancer research hospitals, has chosen to use Archer across multiple sponsors and investigator-led trials.
IgniteData is transforming the future of clinical trials through its cloud-based Virtual Research Assistant, Archer. A system-agnostic solution, Archer brings modern interoperability between EHR and key research applications, such as EDC. Providing seamless, secure transfer of clinical data, Archer is the global EHR-to-sponsor solution for modern clinical trials.
If you would like to get in touch or request a demo, please use our contact form.
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