Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation software and advanced drug development solutions, today announced a partnership with the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development organization that discovers, develops, and delivers safe, effective, and affordable treatments for neglected patients around the world.
DNDi, through its Data Management and Biostatistics (DMB) Centre in Nairobi, will leverage Certara’s data science platform, Pinnacle 21 Enterprise (P21E), to standardize data from multiple clinical data sources. This strategic approach aims to optimize data flow, expediting the analysis and submission of new treatments for health authority review, and is in line with the DMB Centre’s objective of adopting standard data exchange formats to support regulatory approval.
The DMB Centre was founded in 2004 in Nairobi, Kenya to provide data management and statistical analysis support for clinical trials conducted by DNDi. Over the years, the centre has also offered its services to other organizations conducting studies in the region, including the World Health Organization (WHO), Médecins Sans Frontières (MSF), and the Kenya Medical Research Institute. Since its inception, the DMB Centre has supported 16 clinical trials for neglected diseases such as leishmaniasis, multidrug-resistant tuberculosis, paediatric HIV, Buruli ulcer, and mycetoma.
This collaborative partnership with Certara marks a significant stride towards enhancing submissions and expediting the availability of treatments for neglected patients worldwide.
‘Pinnacle 21 Enterprise is the same platform used by regulatory agencies such as the Food and Drug Administration (FDA) to check compliance with agencies’ business rules and Clinical Data Interchange Standards Consortium submission standard. We are happy to partner with Certara as we will be able to reduce the time for regulatory submission preparation,’ said Dr Yaw Asare-Aboagye, Head of Global Clinical Operations at DNDi.
‘It’s a privilege to work with DNDi and support their critical work of developing medicines for neglected patients,’ said Leif E. Pedersen, President, Software, Certara. ‘The goals of DNDi are well aligned with Certara’s mission to accelerate medicines for all patients and transform traditional drug discovery and development through the effective use of technology that advances science.’
Certara’s P21E platform has been rapidly adopted by global biopharma, academic institutions, regulators, and non-profits and is used by over 175 organizations globally to standardize and govern clinical trial data.
‘Quality data and compliance with standards is crucial in clinical research. This tool [P21E] will help us with quality review and analysis for clinical trials in diseases including leishmaniasis, paediatric HIV, and mycetoma. It will also help us generate submission documents promptly for regulatory purposes,’ said Collins Mutua, Head of Biostatistics at DNDi. ‘This will lead to faster drug approval for neglected patients.’
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit medical research organization that discovers, develops, and delivers safe, effective, and affordable treatments for neglected people. DNDi is developing medicines for sleeping sickness, leishmaniasis, Chagas disease, river blindness, mycetoma, dengue, paediatric HIV, advanced HIV disease, cryptococcal meningitis, and hepatitis C. Its research priorities include children’s health, gender equity and gender-responsive R&D, and diseases impacted by climate change. Since its creation in 2003, DNDi has joined with public and private partners across the globe to deliver twelve new treatments, saving millions of lives. dndi.org
Certara accelerates medicines using technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries. Visit us at www.certara.com.
Photo credit: Xavier Vahed-DNDi