Global site success starts with an expert imaging core lab

Contemporary clinical research operates within a global context, in which diverse data sets and global expertise are employed to advance the world’s medical knowledge. A global perspective ensures research findings are inclusive, impactful, and reflective of global public health concerns, while making use of an advanced global infrastructure helps to accelerate medical innovation. 

Global clinical trials can be difficult to operationalize, with complexities and challenges occurring through regulatory and compliance variation, varying site experience, lack of standardized training and logistics, and underlying inconsistencies between geographical contexts. 

Imaging core labs are becoming a key component of ensuring consistency in the imaging components of global clinical trials. This article will consider the leading challenges of imaging in global clinical trials, highlighting the empowering nature of imaging core labs, with a specific example in which  Perceptive Imaging supported  CARsgen Therapeutics in a clinical development program that led to the approval of ZevorCel™ for the treatment of relapsed refractory multiple myeloma.

The leading challenges of global clinical trial imaging

Global clinical trials, specifically global clinical trial imaging, can be challenging to operationalize and manage due to country-specific differences in imaging-related policies and procedures, regulations, and variations in imaging infrastructure. One of the biggest challenges of conducting global multi-center clinical trials is navigating the varied regulatory landscapes of different countries while ensuring strict adherence to standardized imaging protocols. Global trial design is becoming increasingly complex, with multiple treatment arms, stricter endpoints, and adaptive, multicenter trial designs. Ensuring imaging consistency across global sites is essential to avoid protocol deviation, which can lead to non-compliance and regulatory concerns over imaging integrity.

Logistical imaging challenges are extremely common, particularly felt by clinical trial operations teams. Clinical trials often occur over multiple time zones, languages, and healthcare systems, with different communication styles and technologies requiring expert guidance. Coordinating global teams with the experience needed to collect, manage, and analyze imaging data relevant to specific imaging modalities and therapeutic areas is extremely complex. Difficulties with participant recruitment and retention can also occur in a global context, specifically the recruitment of a diverse population, which may, in some cases, limit the generalizability of the imaging data collected.  

Image acquisition and data management are other challenging aspects of global clinical trials. Collecting and storing imaging data from multiple global sites requires a solid and highly sensitive technological infrastructure, robust enough to facilitate the integrity of large global imaging datasets. Variable site experience and training can lead to inconsistent image acquisition and reporting, which can have a negative impact on trial data and outcomes. Research teams must also be equipped to integrate imaging data from diverse populations, identifying variables such as gender, age, socio-economic status, and ethnicity in order to clarify the generalizability of results.

Misalignment between sponsors, CROs, clinical operations teams, and imaging experts can lead to poor communication and inefficiency. Your choice of an imaging core lab partner is one of the most important decisions. Global site success starts with expert imaging support, and experienced imaging core labs can become the bridge required to overcome these challenges and ensure global clinical trial imaging consistency. 

An imaging core lab with global reach

Global clinical trials succeed when all components, including communication, protocols, teams, and technology, align with both local realities and the overarching research objectives. Perceptive Imaging works with sponsors and operational teams globally to ensure consistency throughout the entire clinical trial life cycle.

Perceptive Imaging enables global trial sites to capture high-quality, protocol-compliant images through scientific expertise, comprehensive training and tools, and a leading global technological infrastructure.

Perceptive’s imaging core lab drives global consistency via:

• Consistent imaging protocols
• Site setup and qualification, including phantom scans, site equipment checks, and site onboarding
• Imaging technologist and site staff training 
• 24/7 technical support
• Reader workflows and reviewer training, with study-specific reading criteria monitored for inter-reader variability
• Technology-enabled insight
• Globally scalable services 
• Coordination of image reviewers around the globe 
• Imaging scientists with therapeutically-aligned expertise

Perceptive imaging connects site-level processes and global trial oversight through tightly integrated workflows and comprehensive quality checks.

Case study: Zevor-cel™ Approval for Multiple Myeloma in China

CARsgen, a leading CAR-T developer in China, was advancing Zevorcabtagene Autoleucel (Zevor-cel™) for use in patients with relapsed or refractory multiple myeloma who had previously received at least 3 prior treatment lines. They leveraged Perceptive’s imaging core lab and extensive global expertise to collect imaging data in support of the primary endpoint of thier Phase I/II trial. Zevor-cel™ received approval from the NMPA (China’s regulatory authority) in December 2023 for the treatment of relapsed/refractory multiple myeloma.

Perceptive Imaging supported the Zevor-cel™ approval through:

• Optimal and early imaging strategy
• Global operational expertise and site qualification
• Robust and reliable independent reviewer network
• Seamless collaboration between US and China-based imaging teams
• Ability to meet global regulatory submission deadlines
• 24/7 global support