Two industry innovators have joined forces to take the lead in real-world studies. Clinerion and Cisiv have formed a groundbreaking partnership to offer a revolutionary approach to observational research by enabling automated data transfer from electronic hospital records (EHRs) to electronic data capture (EDC).

The partnering of both companies’ patented technologies will reduce the data entry burden to physicians participating in observational studies, improve data quality and enable smooth and rapid data collection in real-world settings. Clinerion and Cisiv share a vision of using technology to make real-world research leaner, easier to implement and, ultimately, more cost-efficient.

The two companies met at the Real World Evidence conference and quickly found that they possess complimentary technologies. In addition, they share the same spirit of innovation and are positioned to do something concrete in the area of EHR-EDC integration. While the topic has been discussed for ages, little action has been taken in this area until now.

As those in the industry are aware, integrating these two technologies is not without its challenges. Namely, lack of tools to extract data, lack of standardized means for collecting and delivering information from different EMRs to the EDC systems and not all subjects of clinical studies being part of the same health system are just a few of the issues facing integration efforts.

Yet the efforts have the ability to deliver significant results for clinical trials. Through combined technology, these two companies can answer the unmet needs of the pharmaceutical companies for more efficient ways to collect real-world evidence.

The chief executive officers of both companies involved expressed excitement about this new partnership, especially since combining the two technologies can potentially benefit study personnel, provide value to sponsors, encourage more research, enroll more subjects and produce higher quality data. 

According to Ulf Claesson, chief executive officer of Clinerion, “Offering new ways to simplify data collection for studies aligns perfectly with Clinerion’s overall goal of creating new efficiencies in the entire clinical trial process. By saving time and costs in the development of new drugs, speeding up the delivery of new medicines to the patients who need them can be an attainable goal.”  

As Dominic Farmer, chief executive officer of Cisiv, explained, “Clinerion’s innovative technology is a great fit with Cisiv’s unique approach to real-world data, which is one of the reasons the two entities are very excited about this new partnership.“

The connection partnering EHR to EDC is especially important because almost every pharmaceutical company is hungry for innovation.

“There is a big increase in demand for real-world data, driven by new directives from the FDA and EMA. Real-world data is very diverse. Yet the two main ways of obtaining this data are either through a database or through some observational research. Our connection is a way of bringing the best of both, and enabling a more efficient way to conduct observational research,” said Florence Barkats, commercial director for Cisiv.

As Barkats explained, the combined technologies create greater efficiency in the clinical trials process by eliminating the pain of data entry on the part of investigators, recognizing investigators as “partners in science” rather than data entry clerks, improving data quality and reducing the cost of data monitoring.

To further the point of great efficiency, the integration of EHR and EDC helps reduce errors in manual data collection, limited throughput and overall frustration of hospital staff. Inefficient and redundant document processes is both a challenge and a major cost factor for clinical research.

“Phase IV non-interventional studies are set to particularly benefit from making EHR data available to EDC,” said Tigran Arzumanov, head of sales for Clinerion.

According to Arzumanov, this is a unique partnership between the two companies.

“We are not aware of another partnership between a company getting real-time hospital data at the source and an EDC vendor,” Arzumanov said. This partnership creates a number of opportunities, including the ability of Clinerion to install its hardware at no cost to a hospital as part of a project setup. In fact, Clinerion has the ability to install its hardware to work with any hospital information system, allowing for the creation of a global network of hospitals.

Others within the industry see the benefit to combining these two technologies, too.

“As paper-based records are becoming a thing of the past, it is only a matter of time before EHR and EDC will be fully integrated for research. Implementation of user-friendly data entry screens, leveraging existing data system architectures and putting the data entry responsibility at the site level will save time and money, while reducing errors,” said Inger Arum, co-chief executive officer and co-founder of ProTrials Research.

While safe integration of EHR and EDC will require federal regulations be further developed, according to Justin Quilliam, clinical data manager at ProTrials Research, the industry will also have to adequately address related security issues to ensure patient confidentiality. However, Quilliam sees the potential for a broader range of research applications.

“As more hospital systems adopt the EHR model, this will help to quickly identify and screen appropriate candidates for trials, which could save substantially on study startup costs. Additionally, it will help patients find appropriate clinical trials for their specific needs,” said Quilliam.

By creating cost-effective systems with greater efficiency, including improved data quality and rapid data collection, this partnership of EHR to EDC takes the lead in the clinical trials industry. 

This article was reprinted from Volume 21, Issue 29, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »