Overcoming Clinical Trial Imaging Challenges: Three Reasons to Integrate Imaging with the Rest of Your Study Data

Clinical trial imaging poses unique challenges to data handling versus other types of study data. For this reason, it has long been standard procedure to utilize separate software solutions in order to acquire, access, view, and annotate study images. These disparate solutions sometimes don’t play well with other technologies, requiring study teams to spend time and money to make sure image data and resulting analysis are accurately represented in their study databases. So, it is no surprise that researchers have long hoped for solutions that could weave imaging functions into the same platform (or platforms) they use to collect, monitor, and analyze all other study data.

What Makes Clinical Trial Imaging Unique?

Data Quality and Standardization

One of the primary challenges with clinical trial imaging is ensuring the quality and standardization of imaging data. Different imaging modalities (such as MRI, CT scans, and X-rays) and equipment from various manufacturers, not to mention differences in how image technicians capture images, can produce vastly different results. This lack of standardization can lead to inconsistencies in how images are interpreted and analyzed. 

Increasingly High Volumes of Data

The sheer volume of imaging data generated in clinical trials, as well as the size of the image files themselves, presents another significant challenge. Each patient’s data typically comprises numerous images, leading to massive datasets that require extensive storage and computational resources for analysis. Managing and processing these large datasets efficiently while maintaining data integrity is a daunting task for research teams.

Interpretation Variability Among Image Viewers

Interpretation of medical images often involves a degree of subjectivity, leading to variability in diagnoses and assessments among different radiologists. This variability can introduce biases and inconsistencies in clinical trial results. Employing standardized criteria and training for radiologists and/or other viewers, as well as incorporating computer-aided diagnosis systems, can help reduce this variability.

Integration with Clinical Data

Combining imaging data with other clinical data (like patient history, laboratory results, and genomic information) is crucial for comprehensive, holistic analysis. However, this integration is not easy due to differences in data formats, standards, and privacy concerns. Effective data integration strategies are essential to maximize the insights gained from clinical trials.

Regulatory Compliance and Privacy Concerns

Ensuring compliance with regulatory standards, such as HIPAA in the United States and GDPR in Europe, adds another layer of complexity. Researchers must ensure that imaging data is anonymized and securely stored to protect patient privacy. Adhering to these regulations while maintaining data usability is a delicate balancing act.

The Need for Advanced Analytical Techniques

The use of advanced analytical techniques, such as artificial intelligence (AI) and machine learning, in interpreting medical imaging data is rapidly growing. However, developing, validating, and integrating these complex systems into clinical trials pose significant challenges. There is also the need for large, annotated datasets to train these models, which may not always be readily available.

Addressing the Challenges – The Time is Now for Centralized Data that Includes Imaging

Technology is now available, through solutions like TrialKit, that finally allows study teams to engage with their imaging data within the same platform they use to manage other study data. Yet, processes take time to change, and even though it may be tedious to rely on one or more extra software tools for clinical trial imaging, many may simply be so used to doing it that way that they may be resistant to change. In this case, though, the sooner teams begin to realize the benefits of centralizing clinical trial imaging with other study data, the sooner they can unlock new levels of efficiency. Following are three reasons to begin integrating imaging with all other data functions right now.

#1 Faster Access and Evaluation of Imaging Data

Centralizing your imaging with the rest of your study data means that you can access your imaging data more quickly and easily, enabling faster and more informed decision making. This is crucial for both protecting patient safety (viewers can identify risks and trends much more quickly) and ensuring data quality (discrepancies will be found faster as well). Some research platforms even allow real-time access; researchers can view and interact with the image as soon as it’s uploaded. This allows team members to promptly identify potential issues or noteworthy findings, helping to keep study timelines.

For example, the DICOM viewer integrated into the TrialKit platform (TrialKit PACS) is equipped with a range of tools for in-depth image analysis. The ability to easily zoom, pan, adjust image settings, and annotate images facilitates a more thorough and precise analysis of medical images. Such robust interaction capabilities allow researchers to delve deeper into the imaging data, providing valuable insights that might be missed with less sophisticated tools.

Not only do human viewers get faster access to imaging this way, imaging data can also be fed through whatever existing (and validated) AI solutions are in place. Researchers are increasingly turning to AI and machine learning to help parse through mountains of data to more quickly identify risks to patient safety and data quality, and to reach meaningful conclusions about efficacy faster. Integrating imaging data with all other study data serves to add even more valuable data points, making AI tools even more effective.

#2 All Data Available for Analysis in the Same Place

There is significant value in the ability to integrate imaging analysis with other study analytics. For example, image viewers can access image files within TrialKit, make notes and assessments, and then immediately draw correlations between analyzed imaging data and other study metrics, all within the same platform. This means that research teams can reach much deeper, more holistic study insights faster than ever. Clinical trial imaging requires review by multiple experts in order to ensure that what any one reviewer finds is confirmed or debunked, and to help reduce bias and variability. Uploading and storing images in one platform that also allows for intuitive review and adjudication, helps reviewers to work together more efficiently, often in real time. They can click through to see others’ findings and notes and offer their own insights. Confirmations can come more quickly, allowing reviewers to move on to new image sets. This also helps to speed the time to adjudication, when necessary. This level of collaboration is essential to ensuring the accuracy and reliability of clinical trial imaging data, particularly as data volumes continue to increase in modern studies.

Another key advantage of this approach is its ability to streamline clinical trial workflows. By integrating DICOM images and creating a centralized hub for all study data, researchers can eliminate the need for separate systems to view and interact with imaging and other trial data. With all the data in the same place, there is no time lost transferring imaging analytics from one platform to another. 

Having all of your clinical trial data in one place also allows for the use of useful features and techniques such as TrialKit’s customizable dashboard reporting. Team members can generate a dashboard with the push of a button that includes at-a-glance analytics taken from all study data, including imaging. This makes stakeholder reporting simple and allows research teams to tailor reports to specific needs and focus areas.

#3 Security, Compliance, and Accountability

Data security and compliance are paramount in clinical trials, particularly when dealing with sensitive medical images that contain identifying patient data. Centralizing your imaging data means reducing the number of digital spaces where this data can reside, thus reducing the risk of breach. Further, using strong solutions that are built around the world’s strictest standard for privacy and security, like GDPR, help ensure data protection.

Further, the integrity and accuracy of data can be protected by utilizing platforms with meticulous and comprehensive audit trails. Solutions like TrialKit make it easy for auditors to look back at every single image interaction, leaving no questions as to how each image was reviewed. 


Medical imaging data is essential to helping researchers gain more complete understandings of study participants. That said, there are significant challenges inherent with imaging that researchers must navigate. Efforts to address these challenges can be aided by utilizing a clinical research data platform that seamlessly folds in imaging functionality (acquisition, review, annotation, adjudication, etc.). The integration of clinical trial imaging into such a centralized clinical research data platform like TrialKit offers numerous benefits. From streamlining workflows to enabling real-time access and evaluation of imaging data, enhancing collaborative efforts, and ensuring data security and compliance, the ability to interact with imaging data in the same location as all other study data is a significant improvement upon previous approaches that required multiple software platforms. 

For more information, and to learn more about TrialKit PACS, visit www.crucialdatasolutions.com/pacs.