Things to Consider When Choosing an EHR-to-EDC Solution

The clinical trials industry is undergoing a significant transformation. The pace of innovation is accelerating, and integrating new tools to meet today’s demands is no longer optional. The message is clear: if you’re not moving forward, you’re falling behind. EHR-to-EDC streaming is among the technologies that is taking center stage in the current technological revolution and rapidly becoming an essential tool for sponsors and sites alike.  

EHR-to-EDC streaming address several longstanding challenges in the clinical trials industry. They ease the burden on site staff by automating data transfer, reduce manual errors, minimize source data verification (SDV) time, and accelerate data availability.  

Unfortunately, not all EHR-to-EDC systems were created equal. Knowing what to look for in an EHR-to-EDC provider can make all the difference between measurably improving your data processes and creating additional headaches for your team. This article outlines important aspects to consider when choosing the right EHR-to-EDC.

How many medical centers is the system connected to?

One of the first questions to ask when evaluating an EHR-to-EDC solution is: How many hospitals and medical centers is the system already connected to?  

A solid EHR-to-EDC system will have established connections with a wide network of medical centers, allowing sponsors to stream data quickly with minimal effort. Having an established network of medical centers can widen the trial’s patient pool, enable scalability, and reduce setup delays, particularly for multi-site studies. Look for solutions that offer broad connectivity without requiring costly or time-consuming integrations with each individual hospital. Consider whether the network medical centers are geographically diverse, or whether they’re clustered in specific areas which may limit a study’s scope or diversity.

Ease of use and implementation

No matter how powerful an EHR-to-EDC system is, its value diminishes if it’s difficult to implement or use. It goes without saying that a smooth implementation process not only supports rapid adoption but also builds trust among site staff which is vital to the adoption of any new technology.

Look for solutions that offer:

• Quick onboarding: Systems that can be deployed with minimal training or technical expertise save time and resources.

• User-friendly interfaces: Look for solutions that provide intuitive dashboards to reduce the learning curve for clinical trial staff. Though every solution will claim to be user-friendly, you may find that your team prefers one interface over another. Don’t be afraid to see a demo of interesting solutions to see which one truly meets your needs and preferences.  

Another thing to look for is the integration of ancillary services such as eClinRo, RTSM, EDC, and other standard clinical trial solutions within the platform, which can reduce the number of logins and improve the overall experience for trial staff. If these services aren’t directly integrated, find out if and how they can be.

• Responsive support: Every trial has its own nuances and details that deserve proper attention. For example, every EHR has its own coding system, and every EDC has technical limitations and stipulations that may need to be addressed. A good EHR-to-EDC solution will have a dedicated customer support team to ensure that any technical challenges are resolved quickly, minimizing disruptions to both the setup process and trial operations.

Data security and compliance

Everyone knows that when it comes to clinical trials, data security and regulatory compliance is of the utmost importance. An ideal EHR-to-EDC solution must adhere to strict security and compliance standards, including:

• HIPAA and GDPR compliance: Depending on the geographic location of the trial, ensure the system meets all regulatory requirements for data protection.

• CFR Part 11: This regulation, established by the FDA, establishes criteria for electronic records and signatures. Though EHR-to-EDC software itself does not need CFR Part 11 approvals, all solutions must be fully compliant so as not to compromise the integrity of the trial.

• End-to-end encryption: Secure data transfer protocols protect patient information during transmission.

• Audit trails: Comprehensive logging capabilities enable traceability for regulatory inspections.

Though all leading EHR-to-EDC solutions should meet the highest security standards, but it’s always a good idea to double check every service provider before entering a contract.

Convenient, accessible data

One of the most significant advantages of EHR-to-EDC systems is the ability to provide real-time data access. With that, there are ways in which some EHR-to-EDC solutions provide additional conveniences that are worth considering, such as:

• Convenient data extraction methods: Consider how different solutions facilitate data extraction. Can the data be organized within the platform? Can it be downloaded in different formats? Are advanced reports available?  

• Data harmonization: Is the system able to harmonize data from different EHRs? Will the data be available to the sponsor in the format they require?  

• Unstructured data capture: Can images and other file types be added to the EDC? Is there a way to upload patient data to provide a more complete view?  

Choosing the right EHR-to-EDC solution is more than a technical decision - it’s a strategic one. The right system alleviates staff burden, reduces manual errors, and improves data oversight, allowing for improved trial efficiency and significant cost savings. By prioritizing broad connectivity, usability, and regulatory compliance, sponsors can stay ahead of the curve and optimize their trials for maximal success.

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