About CRScube
CRScube is an eClinical technology vendor, offering a unified platform that includes EDC, RTSM, ePRO, eConsent, eSource, CTMS, RBQM, eTMF and Safety Reporting. We believe our role is to simplify data capture, clinical trial management and data analysis processes. We developed our platform to make eClinical solutions easier to set up and update, and closer to the clinical trial workflows users need to follow. There are not truly transformative eClinical solutions on the market, as every EDC must perform the same functions. CRScube has fine-tuned their solutions to truly simplify workflows across the clinical trial execution.
CDISC Membership Brings Credibility
Our primary motivation for joining CDISC was to establish immediate credibility as an emerging eClinical solution vendor, and to ensure our products were aligned with international data standards. Our membership provided a strong signal to potential global partners and clients that our solutions were built to support data quality, interoperability, and regulatory compliance, which is critical given the strict guidelines we follow like ICH GCP and 21 CFR Part 11. It is important for us to be aligned with the industry’s objectives. For many years, eClinical vendors like us have implemented our own standards, to compensate for the relative lack of comprehensive standards. One of our goals is to reduce the cost of running clinical trials – standardization is one of the best ways to reduce the cost of technology ownership, as sponsors and CROs do not need to reinvent the wheel depending on which vendor they work with. CDISC’s efforts fully align with what I believe our objectives are in clinical trial technology.
Standards as a Core Benchmark, Definitive Blueprints
CDISC Standards served as a core benchmark for ensuring the structural conformity of data since the initial development of our solutions. When updating our solutions, we consistently ensured that CDISC standards compliance was maintained, operating within the boundaries that preserved the essential usability features for our clients. This approach focused on meeting the regulatory compliance required for data collection and management, while simultaneously maintaining the integrity and efficiency of the solutions. Our systems utilize CDISC standards to facilitate the transformation of data into the required format for regulatory submissions. For a solutions provider like us, the CDISC Foundational Standards documentation (SDTM, CDASH, ADaM) and the accompanying controlled terminology are the most invaluable resources. They serve as the definitive blueprints for developing and validating our eClinical systems, ensuring compliance with global regulatory requirements. Additionally, the training sessions and implementation guides for newer standards proved crucial for our product development and quality assurance teams, helping us maintain adherence to standards critical for system validation under GAMP 5.
Embrace Standard Models - Now and In the Future
CDISC will continue to be vital as a leading pioneer of standardized data models for the future of clinical trials. Specifically, the Digital Data Flow (DDF) and 360i initiatives led by CDISC are a clear sign that our industry should embrace standard models now and in the future. This moves beyond traditional methods to maximize the efficiency of data exchange and integration. These new standardization efforts will be a core driver for securing seamless connectivity and interoperability among diverse data sources, thereby accelerating the pace of innovation in clinical research even within stringent regulatory environments. I am an advocate for using CDISC standards, both inside and outside of our organization. I recently presented our progress with implementing the USDM into our platform. I am also going to talk about it at ACDM and SCDM Europe next year. I want to raise awareness of the benefits and what vendors like us are doing, as it will help with adoption. I will also be welcoming Chris Decker on CRScube’s podcast, Clinical Data Talks, where we’ll talk more about CDISC 360i. Working for a Korean company, I’ve come to realise that there is less awareness about CDISC standards in Asia, compared to Europe and North-America. I want to increase awareness in that region, too.
About The Author
Sylvain Berthelot holds a dual role at CRScube, overseeing global marketing activities and contributing to overall strategy. With a background in software development, project management, and account management, Sylvain brings a unique perspective on the market and CRScube’s positioning. In his role, he actively engages with industry experts and peers to understand where the industry is heading and incorporates these insights into CRScube’s direction. “This is where CDISC’s efforts to promote standardization are so important - they signal what clinical trials will look like in the future,” Sylvain shares. Passionate about advancing the industry and contributing to a healthier future, Sylvain also hosts On One Condition, a patient advocacy podcast. Through these conversations, he gains a deeper understanding of the challenges faced by those living with or caring for someone with a chronic illness - “It keeps everything I do in my work in perspective.”