How eSource Replaces the EDC

Why use EDC if eSource has the endpoint data?

In the CRIO article, Automate the protocol with eSource, we described how CRIO eSource automates the protocol, building compliance at the point of capture. CRIO is often asked if we can send the data to the EDC. The answer is yes, if the EDC system’s API allows it. But the broader question is, why?

The goal of a clinical trial is to collect endpoint data as specified in the protocol; the goal is not to populate an EDC system. The EDC system is simply a vehicle to get the endpoint data from sites. It arose in an era when real-time data capture in a clinical setting was not yet normalized.

With CRIO eSource, there is no need for an EDC as long as there is a way for sponsors to query, centrally monitor, lock, and extract the data directly. Why is that? The data captured in CRIO eSource is the most reliable endpoint data. It is the original and contemporaneous data recorded by the site in accordance with the protocol, as discussed in the earlier article.

Re-entering CRIO eSource data into an EDC system for others to review and query is like loading clean laundry into the washer again.

CRIO’s revolutionary new architecture

A traditional site-facing eSource solution cannot be utilized by sponsors. That’s because the sites control the source template and CRA access. CRA privileges are often limited to the minimum required for remote monitoring. To make this a viable solution for sponsors, CRIO has introduced a groundbreaking architecture with three separate components:

First, CRIO Publisher allows sponsors to create, version and publish source templates to sites, thus standardizing the template. Critically, and unique among vendors, the receiving sites can add their own customized visits and procedures to the template – for example, a site could add a pre-screening visit, or a unique site-specific procedure they wish to incorporate as part of their SOPs. This makes source creation a truly collaborative process that reflects site needs.

Second, when sponsors publish the template, sites use CRIO eSource, a site-native workflow tool, to populate the templates with contemporaneous data collection. The data collection is part of a broader workflow designed to streamline site operations and facilitate compliance. For example, CRIO offers integrated patient recruitment, eConsent, EMR integration, patient scheduling/payments, and built-in phone and text communications between the site and the patient. Critically, CRIO’s eSource system has Protected Health Information (PHI), which sites need to run their trials, but this PHI is stored on CRIO’s regionally dispersed servers.¹ In this architecture, CRIO’s eSource database remains local to the geography, thus giving regulators assurance that their citizens’ PHI does not leave their geographic boundary.

Third, when sites save data in CRIO eSource, the data is transmitted to Reviewer EDC, a separate, sponsor-facing application. Only study-level, anonymized data is transmitted. This database is separate from the site database and ensures that sponsors do not have direct access to PHI. Sponsors can use Reviewer EDC to review the visits as they are completed, and query, centrally monitor, lock, medically code, and extract the data.

This architecture gives the site and the sponsor their own specific application and database, allowing CRIO to optimize the user experience for each user type. Publisher and Reviewer EDC work across geographies, which lets sponsors manage a study globally. Both the site and sponsor retain direct ownership over their respective data sets, unlike a unitary EDC system, where there is only one database. This dual database structure embodies the principle of ICH-GCP in that the investigators retain control of their source data.

How this truly transforms research for sponsors

To realize the full potential of this system, sponsors and CROs need to redesign current monitoring and data management processes.

The current process for monitoring and data management is an artifact of the secondary data entry quality of a traditional EDC system. This process actually consists of three review cycles:

1. Monitors perform Source Data Review (SDR) – a review source data directly for accuracy, consistency, compliance with protocol and ICH-GCP, etc.;
2. Monitors perform Source Data Verification (SDV) – to confirm that the data points in source match the data points in the EDC; and
3. Data Management review of the EDC (but not the source) data – essentially a second layer of review, often extraneous with the monitor’s SDR.

With CRIO Reviewer EDC, sponsors can redesign these as one unitary review process, which we call “Clinical Data Monitoring.” This single review process eliminates SDV and folds in traditional DM review activities into the SDR.

In this new model, Clinical Data Monitors review visit data as sites complete them. In this way, monitoring is now being done (1) centrally, (2) remotely and (3) continuously. By reviewing the data in real-time, the clinical team can prevent deviations earlier in the trial, respond proactively to patient safety events, and identify patterns across the study.

An additional advantage over a legacy EDC system is that CRIO eSource secures the Principal Investigator (PI) sign-off of source data as the visits are completed, since it leverages the traditional role of PI’s in reviewing source data contemporaneously as part of their oversight. This model secures PI sign-off where the PI works, instead of forcing the PI to log into an extraneous system (the EDC) and sign-off on data that he or she has most likely not entered or reviewed.

Once the clinical team has reviewed the data, all queries are resolved, and PI sign-off is secured, CRIO Reviewer EDC enables the clinical team to lock the visit. With real-time data locking, sponsors and CROs can accelerate database locks, and time to market.

How much could sponsors save?

On a typical clinical trial budget, 50% of the budget goes to the sites, 10% to other vendors, and 40% to the CRO. The majority of that spend is monitoring, and the rest allocated towards data and project management. CRIO estimates that with the combined savings from travel, monitoring and DM activity, the system has the potential to cut at least 20% of costs, and even more in terms of time. CRIO’s technology allows for sponsors to reimagine their study approach. CRIO introduces a model that streamlines data collection, while at the same time reducing tremendous administrative burden on sites.

How do we ensure sites utilize CRIO? 

As a site selection criterion, sponsors can make it a condition that the site utilize CRIO eSource. In CRIO’s experience, close to 98% of sites would accept a trial on these terms. Additionally, sponsors can leverage CRIO’s built-in site network – the world’s largest virtual network of high-performing, tech-native research sites. As a service, CRIO can work with sponsors to identify specific CRIO client sites for inclusion in the study. These sites are already using CRIO in their day-to-day work and would welcome the opportunity to avoid EDC entry.

On most major therapeutic areas, CRIO can offer over 100 active investigators who, on average, perform better than the industry: already 40-70% better data quality, greater openness to technology (by definition), 40% higher enrollment and 2x the patient diversity compared to the industry average.

With CRIO’s established site network and proven fit for site processes, sponsors should not let a single tech-resistant site usurp the substantial efficiency and quality gains the CRIO system offers. Every year, protocols get more complex, not less. That’s why it’s critical that sponsors automate the protocol to ensure reliable endpoint data.

The traditional EDC system had its time and place. There isn’t a single EDC vendor that can lay claim to the integrity, completeness and accuracy of their endpoint data when compared to CRIO eSource. With CRIO’s unique sponsor-facing solution, sponsors can realize these benefits across the whole trial, not just the part of the dataset collected by the forward-thinking sites that happen to be CRIO clients.

In short, sponsors now have a much simpler, faster and cheaper path to their destination: reliable, protocol-driven endpoint data.

If your CRO is unwilling to work within this paradigm, please contact CRIO for a certified CRO partner who is aligned with your goals of better, faster data at a reasonable price point.

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Footnotes:

1 Currently the U.S., Canada, EU, and Australia.

2 Based on an analysis conducted here. This most likely reflects self-selection (i.e., sites that invest in CRIO are higher performing to begin with) as well as the fact the sites have more time to focus on enrollment. This would be akin to saying people who attend gyms regularly are healthier – one could envision both correlation and causation factors at play.