Interoperability remains the modern technology challenge that won’t go away. This is true of all industries but is particularly acute in clinical research with its unique set of data security and privacy requirements designed to protect patients’ information and their health. New technologies are being developed and implemented all the time, each meant to improve efficiency in one or more specific ways, yet there isn’t (and likely will never be) a singular technological solution that can do everything researchers need to conduct complex clinical trials. Thus, numerous approaches have been sought and created to help all of these disparate technologies to work better together. The results, of course, have been mixed and a panacea has yet to present itself.
One Fundamental Truth
As a provider of such solutions, Crucial Data Solutions (CDS) starts with one bottom-line truth: our customers’ data is just that – their data. Simply stated, if you are running a study, you should be able to access your data, including raw data, whenever and however you want. You should be able to move that data wherever it needs to go, and you should be able to do all these things without being asked to pay more to do so. After all, you have already paid (a significant amount) to collect that data. Charging you to access and move that data would be like the grocery store charging you extra to take the groceries you just paid for out of the store. With TrialKit, our goal is to provide a platform that gives you unfettered access to your study information while simultaneously helping to facilitate interoperability.
Let’s Be Open
One of the ways we deliver this flexibility to customers is through TrialKit’s cloud-based RESTful API architecture. API stands for Application Programming Interface and is a software intermediary that allows different software applications to talk to each other. An important type of API is referred to as REST (representational state transfer technology) and RESTful APIs use Hypertext Transfer Protocol (HTTP) requests to create, read, update and delete data. RESTful APIs are used frequently and widely due to their relative ease of use and their ability to work well across different types of data. RESTful APIs are considered to be open APIs, which make them easily accessed and utilized by software developers.
What does all this mean? It means data can be exchanged securely and quickly, even between very different types of technology platforms. For example, the open API can be very useful in securely and accurately moving data from an electronic health record (EHR) platform to a research-specific electronic data capture (EDC) platform.
It also means easier access to data and less data entry burden for researchers while maintaining compliance. As an example, the open API allows users to link an EDC platform directly to the clinical trial management system (CTMS) so that members of the team no longer have to input data into each system separately; the open API can import this data automatically. TrialKit’s API contributes to 21 CFR Part 11 compliance via edit checks in the EDC system. As an example, a user tags a piece of data as being monitored within the EDC system, which triggers the API to make a similar notation in the CTMS.
The Benefits of Direct, Secure Access to Your Data
TrialKit’s open API architecture gives users real freedom. Using the API, users can effectively analyze and move data from any EHR format or other unstructured eSource into a clinical trial database as clean, structured data (TrialKit AI). Researchers are now using it to integrate all manner of data platforms ranging from central labs to CTMS and beyond. With the growing use of decentralized clinical trial approaches that include remote data collection from smartphone apps, wearable devices and other methods, the ability for the API to securely and accurately facilitate the exchange of huge amounts of patient data is extremely useful. This ability also opens things up for researchers, allowing them to dramatically expand the types of data they collect and even include additional endpoints. The freedom afforded to research teams by TrialKit’s API means fewer limits to how they design studies and collect and manage data. Easier access and more control of data can only result in more efficient studies that help make new therapies available to patients faster.
For more information about TrialKit and its open API architecture, or to start a conversation about how TrialKit can benefit your studies, contact us today.
