DNDi

About DNDi

The Drugs for Neglected Diseases initiative (DNDi) was born on the frontlines of medical action. DNDi is an international, not-for-profit research and development organization. DNDi discovers, develops, and delivers treatments for neglected patients in poor and vulnerable communities around the world. Their treatments are affordable and patient-friendly – and have already saved millions of lives. 

With offices on five continents, DNDi works to ensure the people most affected by neglected diseases are part of medical research and development, helping to set priorities, strengthen capacity, and deliver new treatments where they are needed most. 

Curing Rare Diseases With CDISC

Drugs for Neglected Diseases initiative (DNDi) joined Clinical Data Interchange Standards Consortium (CDISC) to align with global standards to enhance data quality, interoperability, and regulatory compliance. The increasing demand for sharing clinical trial data and the need for harmonized data formats made CDISC a natural partner in our pursuit of excellence, making our data available not only for regulatory agencies but also for secondary use. 

CDISC membership has provided opportunities to enhance the skills and capacity of our team to design and execute trials efficiently. It has helped us reduce data variability, streamline the process of data preparation, and we expect to improve collaboration across global teams—directly supporting our organizational mission to deliver faster, safer treatment to neglected patients. 

Standards Transforming Workflows

CDISC Standards like Clinical Data Acquisition Standard Harmonization (CDASH) and Study Data Tabulation Model (SDTM) have transformed our data workflows. They’ve enabled consistent data capture, simplified statistical analysis, and ensured readiness for regulatory submissions, especially with agencies like the Food and Drug Administration (FDA) and European Medicines Agency (EMA) that require CDISC-compliant formats. 

In our recent trials for visceral leishmaniasis and filarial, implementing CDISC standards upstream from CRF design we expect to significantly reduce time from the database lock to availability of analysis datasets. The standardized structure allows for real-time data sharing and faster interim analysis, which is critical for a platform trial such as our ongoing filarial eWHORM project. 

The most valuable CDISC resource has been the CDISC library which has given us access to the official implementation guides, Controlled Terminology, Define-XML standards and submission guidelines. We have also benefited from the collection of examples and various articles on different topics on the CDISC website. 

We emphasize that CDISC standards are not just regulatory requirements but rather strategic enablers. By showcasing improved timelines, reduced costs in the long run, and enhanced data quality, we demonstrate tangible return to investment to internal teams and external partners. 

Accelerating Development of New Treatments

Our organization benefits from CDISC community primarily through access to CDISC resources that contribute to our research needs. We regularly participate in CDISC webinars and we contribute to the community by providing feedback on issues identified through validation tools and how to best improve the standards to cater for various therapeutic areas. Our investment in CDISC Membership aligns with our organizational strategic goals of accelerating the development of new treatment for neglected patients. It supports our commitment to data integrity and positions us as a forward-thinking leader in clinical research for neglected tropical diseases (NTD). CDISC Membership is a catalyst for innovation. As trials become more decentralized and data sources more diverse, CDISC standards provide the backbone for integrating and analyzing these complex datasets efficiently. Don’t wait for a regulatory mandate to consider CDISC Membership - it should be embraced early. Start with pilot projects, invest in training, and engage with the CDISC community. The long-term benefits in efficiency, compliance, and innovation far outweigh the initial learning curve and cost.