DNDi Utilizing Pinnacle 21 Enterprise (P21E), Certara’s Data Science platform for Biostatistics, Data Management, and Data Standards to Streamline Clinical Data Flow
PRINCETON, NJ/NAIROBI, KE, 2023 年 7 月 31 日 – Certara, Inc. （纳斯达克股票代码：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 DMB’s objective of adopting standard data exchange formats to support regulatory approval.
“Pinnacle 21 Enterprise is the same platform used by regulatory agencies e.g., Food and Drug Administration (FDA) to check compliance with agencies’ business rules and CDISC 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.
Since its inception in 2004, the DMB Centre has advanced clinical research by providing data management and statistical analysis support to more than 16 clinical trials conducted by DNDi and esteemed partner organizations, including the World Health Organization (WHO) and Médecins Sans Frontières (MSF). The collaborative partnership with Certara marks a significant stride towards enhancing submissions and expediting the availability of treatments for neglected patients worldwide.
“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 [Pinnacle 21 Enterprise] 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.”
About DNDi
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, pediatric 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
关于Certara
Certara accelerates medicines using technology and services to transform traditional drug discovery and development. Certara clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries. Learn more at www.certara.com.
