Introducing OpenClinica UniteTM, your integrated EHR eSource solution
OpenClinica recently announced the launch of its electronic health record (EHR) eSource solution, OpenClinica Unite. Unite makes it easy for research teams to instantly obtain the data already sitting in the site’s EHR that is needed for the study protocol. OpenClinica Unite was developed in response to the struggle clinical research professionals face every day to get their study data captured, scrubbed, and finalized. With Unite, research teams are able to dramatically reduce the time it takes to get finalized data, accelerating research while reducing costs.
So what is OpenClinica Unite exactly? And how exactly does this solution improve clinical trials?
We sat down with OpenClinica Co-Founders Cal Collins and Ben Baumann to get the details.
Q: Thanks to you both for sitting down with me today. Please describe the problems with clinical research today that Unite is able to solve.
Cal Collins: EHRs already play a crucial role in studies today as the source record for much of our trial participant data. Unfortunately, getting that data requires manual transcription from the EHR into the EDC (electronic data capture) system. It can take weeks or months for data already in the EHR to be transcribed into the clinical trial database… and once it is, the data then needs to be reviewed, queried, cleaned, and verified. This is nearly an entirely manual process that is slow, expensive, and ripe for error. Research coordinators, monitors, and investigators have to log in to multiple systems at once, track patient IDs and compare data across systems, and do a whole lot of other things that add extra clicks and unneeded cognitive overhead to the process. These costs are huge. They are often hidden, or just accepted as unavoidable. The great thing is, now we can do something about it.
Q: Can you walk us through the process that clinical research coordinators face when tasked with capturing research-grade data?
Ben Baumann: Clinical research coordinators (CRCs) are the unsung heroes who work every day to make clinical research happen. Oftentimes they support multiple trials at once and juggle many competing priorities. They are the ones primarily responsible for gathering the study data and performing data entry. And when they must enter data, they have to do so in multiple places while also dealing with large binders of paper files. It can get quite complicated and adds to the level of burden and burnout that they face. There’s a lot of inefficient clicking through multiple screens in the EHR to assemble data for even the simplest case report forms. We’ve seen more than 30% of research coordinators say that they experience stress because of the strict requirements in sponsor contracts.1 And as more CRCs burnout, they are quitting their jobs and leaving their research sites with even more work to do during an already unprecedented time.
Q: What does Unite mean for the Case Report Form (CRF)?
Ben Baumann: Case reports forms have traditionally been the place where data are manually entered, reviewed, cleaned, and verified. OpenClinica Unite allows sites to pre-populate electronic CRFs (eCRFs) with existing EHR data in a single click. As a result, study team members can now spend more time using case report forms to view/reference data for individual patients, and less time using CRFs to enter, update, and clean this data.
Q: So what does Unite mean for clinical research sites?
Cal Collins: OpenClinica Unite reduces frequent, routine tasks from hours to seconds. This means that site staff can spend less time on data entry/cleaning, and more time on higher value activities like interfacing with patients. Unite seamlessly dovetails into the clinic’s daily workflow and EHR they already use, placing less burden on site staff to learn new systems and create new processes. One of the biggest barriers to achieving anything like this has always been the up-front cost of integration. OpenClinica has shown that it doesn’t have to be this way. We can fully integrate with a site’s EHR in a couple of weeks, in a way where they’re very happy with how we do security, privacy, and maintenance. And once that’s in place, it can be easily used for many other trials.
Q: And what about clinical trial sponsors?
Cal Collins: Unite gives sponsors more accurate and complete data, and gets them much faster access to this data. Unite automatically ensures that the data in your EDC system is the same as the data in the EHR, thereby eliminating the need for source data verification (SDV) for those items. All of this means that sponsors have more productive, happier sites, which are more likely to remain engaged as valuable research partners. And finally, it means that, for the first time, sponsors can realistically work with sites that may not have all of the traditionally required infrastructure to participate in clinical research.
Q: How would you assess Unite’s potential to have an impact on clinical development as a whole?
Cal Collins: We’ve been fortunate to work with great partners to develop on-the-ground experience in what works and what has the most impact. Users of OpenClinica Unite use words like ‘life-changing’ and ‘’extraordinary’ when describing its impact on their trials. At a macro level, the median cost of bringing a treatment to market is somewhere around a billion dollars.2 When there’s an awful lot of different activities represented in this number, speed and accuracy of data collection can have an outsized impact on reducing costs and accelerating the clinical development timeline. If you don’t capture clean, accurate data, your trial becomes less effective and takes longer. If you look at how many studies are typically needed in order to achieve marketing authorization, reducing the time each study requires while improving the quality of data has the potential to significantly shorten overall time to market and take quite a bite out of the overall enormous clinical development cost.
Q: Is OpenClinica Unite regulatory compliant?
Cal Collins: Yes. OpenClinica Unite is 21 CFR Part 11 and ICH GCP compliant. It is also compliant with HIPAA and GDPR requirements. Unite has also been reviewed and validated by many health system IT departments and major EHR vendors.
Q: How can people learn more about OpenClinica Unite?
Ben Baumann: We invite anyone who wants to see a demo of the OpenClinica Unite solution to contact us. If you’re looking for additional information, we invite you to download our guide which provides more detailed information on the rigorous compliance standards that OpenClinica Unite adheres to as well as the implementation process, user experience, and customizations that it offers.
We want to thank Cal Collins and Ben Baumann for their time and look forward to speaking with you more about OpenClinica Unite.
There are many factors that will determine what tools you need for your study to be successful, but at the core you should be considering an EDC that allows you to capture, review, and analyze/report clinical data. (*Check out our Ultimate eCRF Design Guide for getting better data faster from your clinical sites and study participants.*) Integrating modules within your electronic data capture solution is another area for consideration. The benefits of electronic clinical outcome assessments (eCOA) / electronic patient reported outcomes (ePRO) is one example that has been talked about for several years. But with OpenClinica Unite, you’re able to eliminate many of the hours that clinical research sites devote to simply transcribing data which has a monumental impact on the efficiency and effectiveness of a clinical research site and its sponsor.
- Bastek, Andrea. Combating the burnout bottleneck among clinical research workers. STAT News. 2021 September 13.
OpenClinica’s vision is to drive the future of digital clinical trials with innovative technology and more seamless integration with the healthcare system. We do this by transforming healthcare through innovative cloud technology that simplifies running clinical trials. Proven in over 10,000+ studies worldwide, the OpenClinica platform is trusted by leading biopharmaceutical companies, contract research organizations, academic institutions, and government agencies. OpenClinica is used across a wide spectrum of clinical research, including drug, device, and diagnostic trials, global health studies involving 2,000,000+ patients, adaptive platform trials, and clinical trials for some of the first gene therapies to be approved for market. Hundreds of small, midsize, and large research organizations leverage OpenClinica to capture better clinical data faster, and to do so in a way that meets the highest standards for security and regulatory compliance (21 CFR Part 11, Annex 11, GDPR, HIPAA).
OpenClinica, LLC is headquartered in Waltham, MA. For more information on OpenClinica’s solutions for electronic data capture (EDC), EHR eSource integration, real-world data, ePRO, randomization, and analytics and reporting – visit www.openclinica.com.