Good research data management is one of the primary challenges faced by medical institutes and hospitals. Most of the existing multipurpose tools for electronic data capture (EDC) within the medical research world are not user-friendly or researcher-friendly, and are very expensive. At the same time, general-purpose tools, such as Microsoft Excel, Microsoft Access, and Google Forms, are not intended to be used for medical research as they are not secure, are susceptible to data leaks, and are not compliant with ICH E6 Good Clinical Practice (GCP) guidelines.
Radboudumc is one of the global leaders in medical research. They have been contributing to innovative, sustainable, and affordable healthcare in the Netherlands and the rest of the world for more than sixty years. With a total of almost 10,000 employees, 3,500 students, and thousands of annual scientific publications, Radboudumc ranks among the world-class University Medical Centers delivering high-quality participatory and personalized healthcare.
Inefficient and non-secure data capture tools
User-friendly, secure, and compliant EDC
Exponential increase in number of running studies
Challenge: Inefficient and non-secure data capture tools
Before the adoption of Castor EDC, Radboudumc used a tool that did not enable self-service and required continuous support from the central research office. This meant that researchers were unable to build clinical studies by themselves. This was not only time consuming, but also expensive as Radboudumc was required to periodically hire specialists to help its researchers and maintain the cumbersome software. Furthermore, there were potential weaknesses in data analyses as researchers risked making errors while manually copying their data from the hospital information system into their own studies. In addition, researchers could not comply with all the laws and regulations for clinical trials and this “gradually incited uproar among them,” Ariaan Siezen, Project Leader Radboudumc, explained.
A significant hindrance for Radboudumc, much like many other medical institutes, is the non-reusability of data. Due to poor data quality, a lack of standardization, and accessibility of data to other researchers, a majority of medical research data is never reused. This has a two-fold negative effect: 1) it impedes cooperation between researchers as they do not know if others are working on similar projects and 2) research institutes lose unique scientific insights that result from running analyses across standardized datasets.
Solution: User-friendly, secure, and compliant EDC
In two years since the adoption of Castor EDC, Radboudumc has seen the number of running studies increase from 60 to 1,000 with a total of 1,600 happy researchers using the platform. Here is a breakdown of how Castor EDC helps accelerate medical research:
1. User-Friendliness: Designed by researchers for researchers, Castor EDC has everything a researcher needs to define a study structure and capture data. Its ease of use enables researchers, regardless of their technical knowledge, to make advanced, intelligent forms for small or big studies (eCRFs), create randomized trials, develop registries, and capture patient data electronically (ePRO).
2. Affordability: Radboudumc provides Castor EDC to all their researchers with additional benefits, such as GCP compliance, centralized data capture, and standardization, at no cost to the researcher.
3. Compliance and Safety: Castor EDC complies with all applicable regulations for clinical trials, including ICH E6 GCP, 21 CFR Part 11, EU Annex 11, and the European Data Protection Directive. It includes an audit trail which logs every action taken in the system in compliance with GCP regulations.
4. Reusability of data: Castor EDC provides standardized forms, surveys, and calculations that can be exchanged among users. The data captured is saved in accordance with FAIR (Findable, Accessible, Interoperable, Reusable), so it can be easily reused and exported to other applications.
5. Epic EHR Importer: Together with Radboudumc, Castor EDC developed the first HL7 FHIR based Epic EHR importer in the world, which can easily pull data from electronic health records and copy it into a Castor study. The importer eliminates the errors that result from researchers manually typing from one screen to the other and saves hours of valuable time. Within one year, the importer could save Radboudumc the equivalent of 70 full-time employees copying clinical data into data systems.
6. Powerful Features: Features such as the “Automation Engine” make researchers’ lives easier by automating common tasks, while the RESTful API enables integration with other research platforms, and the ePRO module captures data at its true source: the patient.
7. Customer Support: With a team of in-house experts, the customer support team understands the needs of every user. Online support is easy to access and users receive an answer to any query within 24 hours.
8. Monthly Updates and New Features: Castor EDC has monthly releases of new features and updates based on customers’ feedback, thereby continuously improving the platform.
Researchers can do fantastic things with Castor EDC! They can create a study exactly as they need, in line with their study protocol, and change it when necessary. Not a single researcher is disappointed. One particular researcher was so creative that he incorporated a large part of the protocol in the study structure.
Remco den Ouden, Radboudumc Information Management
Power of the truly independent researcher
Castor EDC believes in the power of an independent researcher with tailor-made support. With state-of-the-art technology and a network of experts, its mission is to provide reliable and secure electronic data capture to all researchers worldwide. With this mission accomplished at Radboudumc and over 100 other renowned institutes around the globe, Castor EDC is more motivated than ever to continue making medical research faster and smarter.