Challenge Series – Over 8,000 Trials and Counting – Why the Leading Names in Research Love Taking Control of their Data with TrialKit

Modern clinical trials require modern solutions. Effective clinical research today depends on flexible study designs that build in the ability to make quick changes based on study performance. These studies need to be able to collect and manage massive amounts of data from multiple, disparate sources. Researchers are looking for solutions that allow them to stay on top of all this data while maintaining control – they want to do more themselves and rely less on expensive third-parties.

This is made more challenging by trends like the growth of decentralized trial elements. An increasing number of studies include remote elements that allow patients to participate from home, including the kinds of remote geographies that used to be unreachable for researchers. Recent data shows that nearly a quarter of all clinical trials now include some type of remote data collection.¹ This will only increase as our industry strives to reach more diverse populations of patients, many of whom lack reasonable access to clinical trial sites.

To help meet challenges like this, innovation is happening constantly. Experts across all industries, including clinical research, are exploring how advances like artificial intelligence (AI) and machine learning (ML) can help drive new efficiencies. The research space is poised at the beginning of what promises to be a transformative period in its history as everyone works to leverage exciting new ideas and methods to significantly accelerate the development of safe, effective new therapies.

The need to keep pace with innovation while being prepared to implement future solutions, all while staying in full control of study data, points to the key reasons that TrialKit users choose to configure and conduct their studies on the platform. This paper will explore these reasons in more detail to provide a sense of how TrialKit enables modern clinical trials and helps pave the way for future innovations.

What Does TrialKit Do?

TrialKit is a cloud-based, end-to-end clinical research platform. It is purpose built to simplify clinical trial builds and facilitate efficient, effective clinical trials. Using a drag-and-drop development environment that requires no programming gives research teams the ability to jump right into study design without the need for deep coding experience and without the need for often expensive third-party developers. TrialKit is the first platform of its kind to offer researchers access to study data via a native mobile application in addition to web-based access.

TrialKit brings all clinical trial build and management capabilities into one platform. These include:

• EDC
• eCOA/ePRO
• eTMF
• Site Payment Manager
• Clinical Adjudication
• Easy Data Transfer from EHR to EDC
• Remote Patient Monitoring and Wearables
• eSource/Direct Data Capture
• eConsent
• RTSM/IRT
• Data Reporting and Analytics
• Medical Coding
• Televisits and Scheduling

Why TrialKit?

It is Easy to Use

The TrialKit user experience is built to be as intuitive and unobtrusive as possible. The user group for modern clinical trials is vast and continues to grow. The list includes site teams, sponsor teams, CROs and, increasingly, the study participants themselves along with their caregivers. TrialKit makes things simple for all types of users, whether they are a patient having their first research experience or a site coordinator with 10+ years of experience helping to manage trials. TrialKit is developed to be easy to learn, easy to implement and easy to use every day by all users.

No Programming Required

With TrialKit, users do not need to be experienced programmers. This kind of development platform simplifies the user interface so that users can easily build new applications and/or custom-tailor existing applications. In this way, TrialKit can help to significantly speed up aspects of study design, helping get trials up and running more quickly without the need for users to spend hours coding and/or avoiding the need to involve third-party coders at additional cost. Study leaders can drag and drop the application components they want while avoiding components and features that add more cost than value.

The Advantage of Open API Architecture

The cloud-based Open API architecture of TrialKit enables the fast, secure, and easy transfer of data between the many varied technology platforms common in clinical trials. API stands for Application Programming Interface and is a software intermediary that allows different software applications to talk to each other. TrialKit’s architecture, for example, is extremely useful for transferring data accurately and securely from electronic health record (EHR) platforms to a given study’s research-specific electronic data capture (EDC) platform. EHRs are a source of data that has not yet been fully mined, and digging into what is available more completely promises several benefits for researchers, such as finding new endpoints, discovering new population health trends, and improving patient recruitment – among others. TrialKit’s open API has the ability to help researchers overcome interoperability roadblocks and take advantage of the massive amount of raw, unstructured data present in EHRs.

It is Your Data, All in One Place

Complex, modern clinical trials are collecting data from multiple sources, often requiring study teams to work with multiple disparate technology applications and platforms. TrialKit helps teams to bring all this data to a single point where users can access it in an understandable and useful format. This saves time and costs while helping teams focus on other critical tasks, like patient engagement.

With TrialKit, access to data is paramount. TrialKit allows its users continuous, immediate, and easy access to their own data at any time. Further, TrialKit is the only solution that allows approved users (based on access rules configured by the study team) to access data from a native mobile application in addition to its web-based app.

It is Scalable and Extensible

TrialKit’s design allows users to grow and shape how they use the platform based on their specific needs. Users can easily add or subtract functionality and pull useful assets from one study and implement it across their entire portfolio with the push of a button. Research teams have the ability to easily add capabilities like video visits, ePRO, or passive data collection from wearable devices. The platform allows teams access to data from either a mobile or web-based application, meaning they can spot trends quickly. From their phone they can upscale capabilities that are working well or scale back on data collection methods that are not as effective.

TrialKit is Affordable

TrialKit has adopted an affordable, subscription-based enterprise cost structure that takes much of the risk out of selecting a clinical research technology platform. Understanding that traditional fee-for-service models often result in ballooning costs due to change orders and implementing design elements that prove ineffective, TrialKit makes it possible to swap features in and out based on performance without wasting money. TrialKit enables:

• Easier infrastructure tweaks necessary to implement the various applications and technologies being used
• Fast, comprehensive and easy-to-digest training
• Implementation and start-up without the need for additional third-parties
• Data hosting
• Reduced personnel hours made possible by simplified, intuitive study building
• Free, easy access to data – researchers never have to pay extra to access their own data

The subscription option provides a more cost-effective solution versus fee-for-service models by eliminating opportunities for change orders and cost-creep. Users can enjoy the flexibility and scalability of the platform without worrying about additional spend, which allows for more predictable budgeting.

Conclusion

Clinical trials are extremely complex. Advances in technology and continuous innovation, while helping to improve how research is conducted, are adding new complexities all the time. These complexities can easily cause costs to balloon as researchers add technology and turn to third parties to help figure out how to use it. This is why more clinical research sponsors and CROs are choosing to configure and conduct their clinical trials using the TrialKit platform. With TrialKit, researchers have the freedom to build studies themselves quickly and easily, scale those studies, and swap features in and out without worrying about cost overruns. No other research technology platform provides users the ease of use and level of access available with TrialKit. This access – whether through the platform’s native mobile app or via the secure, cloud-based web app – helps researchers to meet the real-time demands of modern clinical trials without giving up any control over their data.

For more information, visit crucialdatasolutions.com

¹ Partner, Q. (2023, July 24). Decentralized clinical trials – a growing trend driving improved patient outcomes. Fierce Pharma. https://www.fiercepharma.com/sponsored/decentralized-clinical-trials-growing-trend-driving-improved-patient-outcomes#:~:text=Decentralized%20Clinical%20Trials%20%E2%80%93%20a%20growing%20trend%20driving%20improved%20patient%20outcomes,-Sponsored%20by%20DHL&text=Over%20the%20past%20few%20years,%E2%80%93%20or%20Virtual%20%2D%20clinical%20trials.