Ecommerce has driven the implementation of new technologies and modern architecture to allow for integrated processes, informed decision making, smooth end-to-end transactions and data safety. The growth of ecommerce has spurred expectations of consumer-like experiences in the life science industry.
Modern software development concepts from ecommerce applications are helping eClinical applications meet the precise needs of each clinical trial. While the pace of adoption in the highly regulated clinical trial industry is measured and cautious, many eClinical products can now integrate data from multiple sources and seamlessly access and share data across applications.
Ecommerce and eClinical have many similar goals, such as providing a seamless and easy user experience, having all technology transactions happening in one place in an end-to-end fashion and meeting strict data security requirements and GDPR regulations. The challenge for eClinical developers is in applying lessons learned from the ecommerce industry to eClinical solutions.
There are ongoing efforts to apply many of these lessons learned and the adoption of modern software development concepts like microservices architecture is having a positive influence on eClinical software development. Microservices is an approach to application development that allows a large application to be separated into smaller independent parts. Each of these parts is responsible for a certain task and can communicate with other parts though application programming interfaces (APIs).
Challenges for IRT
Interactive response technology (IRT) development is a traditionally risk-averse business because IRT systems randomize patients and determine what investigational drug is administered to a participant, among other critical trial functions. Therefore, the integrity of an entire clinical trial depends on this technology.
Although eClinical professionals are often reluctant to change IRT systems, rising complexity in clinical research is creating the need for more innovative IRT platforms. For example, most clinical trials now have multiple protocol amendments. Adaptive clinical trials require quick updates and flexible features to support functionality such as dropping treatments for futility, declaring one or more treatments superior, or adding new treatments to be tested during a trial. IRT platforms must meet the requirements of every protocol version starting from version 1.0 until database lock, with minimal downtime.
For YPrime developers, embracing microservices means the ability to speed development and deployment for discrete functions and simplify integrations with other clinical trial process applications. They reduce the risk of impacting the whole application when making changes to an independent function.
Making IRT Platforms More Site-Centric
IRT users at clinical trial sites often worry that they will need to learn a new technology and remember another login. With up to a dozen or more systems to manage on a single trial, sites are often overwhelmed, especially when managing multiple, concurrent trials. Design considerations for site user experience are critically important for IRT systems.
Modern architecture like microservices enables technology providers to integrate or embed their IRT system into other systems. This way, the site user has one place to go to complete everything they want using single sign-on (SSO) technology, and they have an easier end-to-end experience.
The Benefits of a Flexible IRT System
Many clinical trials today need to be implemented rapidly and adapt to protocol changes, so a flexible IRT platform with streamlined delivery and change management processes can help sponsors reduce costs and improve speed. This ultimately helps to get medicines to the market faster. Modern architecture enables consolidating data from multiple sources, simplifies access to this data with more avenues to use it, and empowers better-informed decision making.
From a human resources perspective, sponsors always expect excellent project managers, but often overlook the necessity for great developers and testers within their organizations for what is rapidly becoming a “digital first” environment for the life science industry. Excellent developers and testers are naturally attracted to modern and cutting-edge solutions that are enabling next-generation medicine.
As users of the IRT system, clinical supply professionals benefit from microservice architecture because they have the flexibility to choose their own front-end experience and not be limited to a provider’s core product. Through one platform, they will be able to select and implement what they need for each trial whether it is randomization only, clinical supplies only, an investigator-initiated trial, cohort management, or an expanded access program.
In working with sites, clinical supply professionals, and sponsors, YPrime developers have gained important insights into the site workflow. A robust, flexible IRT system enables sites to have a voice in their experience and reduce the site technology burden.
New IRT functionality will continue to evolve as advancing software development concepts facilitate new solutions to reduce time and cost in clinical research and support emerging research methodologies. Look for innovations and additional solutions as these trends take shape.
The editorial staff had no role in this post's creation.