Intego Clinical

About Intego 

Intego is a biometrics-focused CRO providing biostatistics, statistical programming, and data management services for clinical trials. Intego helps sponsors transform complex clinical data into consistent, high-quality, submission-ready results by adhering to CDISC Standards such as SDTM and ADaM, ensuring data is precise, reliable, and easily interpretable across studies and organizations. This benefits not only Intego's clients but also the broader scientific community, as their work meets high industry benchmarks. Through standardization and strong delivery processes, Intego supports better regulatory confidence and stronger scientific outcomes. 

Straightforward, Submission-ready Pathway 

CDISC Standards play an important role in enabling a straightforward, submission-ready pathway. By leveraging established standards, implementation guides, and best practices, we ensure that study data is structured correctly from the start, which reduces rework and supports efficient progression toward submission. 

Internally, CDISC is embedded into our processes and training programs and is treated as the default framework for data standardization. Teams are aligned on delivering SDTM and ADaM datasets that are submission-ready, which simplifies downstream analyses and reporting. 

With external partners, we emphasize the importance of adopting CDISC Standards early, regardless of immediate submission plans. Study strategies may change over time, and early standardization helps avoid retrospective conversions, which are typically resource-intensive and carry additional risk. 

Overall, we present CDISC as a practical approach to ensuring consistency, efficiency, and flexibility across the study lifecycle. 

Improving Collaboration and Efficiency Across Studies 

CDISC Standards shape how we design SDTM and ADaM datasets from the beginning of each study. This shortens timelines and lowers the risk of issues during regulatory review.  

On multi-vendor studies, CDISC Standards allow faster integration of data from different sources. Because all partners follow SDTM and ADaM, we spend less time reconciling formats and more time on analysis and validation. This improves collaboration, shortens timelines, and lowers the risk of issues during regulatory review. 

The CDISC Library is one of the most valuable resources for our teams, as it provides a centralized source of standards metadata. Key resources include SDTM and ADaM implementation guides, controlled terminology, and conformance tools such as CORE to ensure alignment with current standards. 

Supporting Future Innovation 

For Intego, standards are the foundation for automation, AI, and advanced analytics.  CDISC enables modern approaches such as centralized monitoring, reuse of data across studies, and more advanced analytics workflows. By continuously improving and adopting standards, we can innovate while maintaining regulatory confidence and operational stability. 

Engagement with the CDISC Community 

Intego maintains active involvement in the CDISC community through participation in industry events, working groups, and knowledge-sharing initiatives. Our team regularly contributes to conferences such as PHUSE, where we present on practical implementation of CDISC Standards, including topics related to endpoints, data standardization, and programming considerations. 

Most recently, our employee Daryna Teteriuk received first place in the “Data Standards” stream at PHUSE US Connect for her presentation “Multiple Sclerosis Trials Unpacked: Standards, Endpoints, and Programming Experience”. 

In addition, our staff have participated in CDISC indication-specific working groups, contributing to the development and refinement of standards. This level of engagement allows us to stay aligned with current CDISC expectations and apply best practices consistently across our projects. 

Aligning CDISC Membership with Organizational Goals 

Our investment in CDISC membership is aligned with our goal of maintaining a consistently high level of data standardization expertise across the organization. It supports both onboarding of new-to-industry staff and continuous upskilling of experienced team members through access to up-to-date standards, guidance, and training materials provided by CDISC. 

Through CDISC membership, we have access to the most current CDISC data standards, implementation guides, templates, controlled terminology, and other supporting materials, as well as disease-specific knowledge and decision frameworks. This allows us to apply standards consistently and in line with the latest expectations. 

We have established internal training programs that incorporate CDISC standards as a core component, ensuring that new team members develop a strong foundation early on. At the same time, CDISC membership enables our experienced staff to stay current with evolving standards and apply them effectively in project work. 

Overall, this investment helps ensure consistency in implementation, supports quality, and compliance expectations, and allows us to scale teams with the appropriate level of CDISC expertise. 

CDISC Membership: A Milestone!  

Joining CDISC was an important milestone for our organization and reflects our commitment to maintaining high standards in clinical data science and management. CDISC standards are essential for regulatory submissions and cross-company collaboration.  CDISC membership provides our teams with continuous access to current standards and training resources. We run global internal training programs, which are embedded into our global internal training programs to support scalable growth without sacrificing quality. 

For organizations considering CDISC membership, our recommendation is to view it as a practical investment in long-term efficiency rather than a compliance-only requirement. Access to current standards, implementation guides, controlled terminology, and supporting materials allows teams to apply CDISC consistently and correctly from the outset. 

Membership is particularly valuable when combined with internal processes and training programs. The CDISC platform provides a wide range of training resources across different topics and levels of complexity. In addition, indication-specific streams offer valuable insights that support informed decision-making based on established industry practices. 

It is also important to consider CDISC early, even if submission is not an immediate goal. Development plans can change over time, and having data already aligned with CDISC Standards provides flexibility and helps avoid complex and resource-intensive conversions later. 

Overall, CDISC membership supports a more structured and predictable path from study data to submission, while improving consistency and efficiency across projects.