• DNDi - Best Science for the Most Neglected 20 Years
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • Pandemic Preparedness
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies and IP
      • Children’s health
      • Gender equity
      • Climate change
      • AI and new technologies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • Dengue Alliance
      • HAT Platform
      • HELP Helminth Elimination Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Switzerland
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia
      • DNDi South-East Asia
      • DNDi Southern Africa
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
      • Podcasts, radio & TV
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
DNDi - Best Science for the Most Neglected 20 Years
  • DNDi - Best Science for the Most Neglected 20 Years
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • Pandemic Preparedness
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies and IP
      • Children’s health
      • Gender equity
      • Climate change
      • AI and new technologies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • Dengue Alliance
      • HAT Platform
      • HELP Helminth Elimination Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Switzerland
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia
      • DNDi South-East Asia
      • DNDi Southern Africa
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
      • Podcasts, radio & TV
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
Home > Press releases

Certara and DNDi partnering to fast-track data submissions and accelerate drug approvals for neglected patients

DNDi utilizing pinnacle 21 Enterprise (P21E), Certara’s data science platform for biostatistics, data management, and data standards to streamline clinical data flow

Home > Press releases

Certara and DNDi partnering to fast-track data submissions and accelerate drug approvals for neglected patients

DNDi utilizing pinnacle 21 Enterprise (P21E), Certara’s data science platform for biostatistics, data management, and data standards to streamline clinical data flow

Man looking into a microscope
PRINCETON/NAIROBI — 31 Jul 2023
Share on twitter
Share on facebook
Share on linkedin
Share on email
Share on print

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.’

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, 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 

About Certara

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

Partnership Africa

Read, watch, share

Loading...
Centre of Excellence in India
News
14 Sep 2023

DNDi’s Centres of Excellence: Towards the sustainable elimination of visceral leishmaniasis in India

Delali Attip
Press releases
6 Sep 2023

Biotech leader Delali Attiogbe Attipoe joins DNDi as North America Director

Viewpoints
5 Sep 2023

Africa should bolster research into climate-sensitive diseases

Context
Prof. Sam Kariuki, DNDi Eastern Africa Director and Leonard Ithau, Rotary International District 9212 District Governor shaking hands
News
29 Aug 2023

DNDi and Rotary collaborate to prevent and treat diseases affecting neglected communities in Eastern Africa

Mother and child in a hospital
Viewpoints
24 Aug 2023

A drug development model for the diseases the world forgot

Africa Arguments
Statements
21 Aug 2023

DNDi urges G20 to operationalize equity in response to major global health challenges and priorities

DNDi Prof. Fahal Interview 2023 Cover Image
Videos
25 Jul 2023

Prof. Fahal On The 20 Years of Innovating Together In Helping Mycetoma Patients

Press releases
20 Jul 2023

Fiocruz signs agreement to register hepatitis C medication with Brazilian health regulatory agency

VIEW ALL

Help neglected patients

To date, we have delivered twelve new treatments, saving millions of lives.

Our goal is to deliver 25 new treatments in our first 25 years. You can help us get there. 

GIVE NOW
DNDi - Best Science for the Most Neglected 20 Years
Facebook-f
Twitter
Instagram
Linkedin-in
Youtube
International non-profit developing safe, effective, and affordable treatments for the most neglected patients.

Learn more

  • Diseases
  • Neglected tropical diseases
  • R&D portfolio
  • Policy advocacy

Get in touch

  • Our offices
  • Contact us
  • Integrity Line

Support us

  • Donate
  • Subscribe to eNews

Work with us

  • Join research networks
  • Jobs
  • RFPs
  • Terms of Use   
  •   Acceptable Use Policy   
  •   Privacy Policy   
  •   Cookie Policy   
  •   Our policies   

  • Except for images, films and trademarks which are subject to DNDi’s Terms of Use, content on this site is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 3.0 Switzerland License   
This website uses necessary cookies to function. If you give your consent, we will also use statistical, functional, and marketing cookies. See Cookie Policy.
Customize
REJECT ACCEPT ALL
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-advertisement1 yearSet by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category .
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
CookieLawInfoConsent1 yearRecords the default button state of the corresponding category & the status of CCPA. It works only in coordination with the primary cookie.
PHPSESSIDsessionThis cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
CookieDurationDescription
elementorneverThis cookie is used by the website's WordPress theme. It allows the website owner to implement or change the website's content in real-time.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
CookieDurationDescription
_ga2 yearsThe _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors.
_ga_16Q5RH3XRG2 yearsThis cookie is installed by Google Analytics.
_gat_UA-10302561-11 minuteA variation of the _gat cookie set by Google Analytics and Google Tag Manager to allow website owners to track visitor behaviour and measure site performance. The pattern element in the name contains the unique identity number of the account or website it relates to.
_gid1 dayInstalled by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously.
_hjAbsoluteSessionInProgress30 minutesHotjar sets this cookie to detect the first pageview session of a user. This is a True/False flag set by the cookie.
_hjFirstSeen30 minutesHotjar sets this cookie to identify a new user’s first session. It stores a true/false value, indicating whether it was the first time Hotjar saw this user.
_hjIncludedInPageviewSample2 minutesHotjar sets this cookie to know whether a user is included in the data sampling defined by the site's pageview limit.
_hjIncludedInSessionSample2 minutesHotjar sets this cookie to know whether a user is included in the data sampling defined by the site's daily session limit.
_hjSession_112884430 minutesHotjar sets this cookie.
_hjSessionUser_11288441 yearHotjar sets this cookie.
CONSENT2 yearsYouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data.
Targeting
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
SAVE & ACCEPT
Powered by CookieYes Logo