CDISC and conect4children (c4c) release of Paediatrics User Guide to facilitate better medicines for babies, children and young people

CDISC and conect4children (c4c) release of Paediatrics User Guide to Facilitate Better Medicines for Babies, Children and Young People

Austin, TX and Newcastle upon Tyne, UK – 22 Feb 2023 – CDISC and conect4children (c4c) have announced the release of a Paediatrics User Guide, freely available on the CDISC website, to facilitate the development of medicines for children.

The User Guide focuses on cross-cutting clinical concepts related to paediatric research and describes how to use CDISC standards to collect and structure data used in clinical trials to facilitate the aggregation of information, take advantage of big data and support data sharing. Adopting CDISC standards is an invaluable investment that leads to more meaningful, more efficient research by streamlining the flow of data throughout the research process.

"We are immensely proud of the c4c and CDISC teams for compiling this guide, which will boost the impact of data gathered during paediatric clinical trials and so help to advance research into diseases that affect children. The guide also shows how IMI projects, by collaborating with global Standards Development Organizations like CDISC, can have an impact on research worldwide, and not just in Europe." - Dr Hugh Laverty, Interim Executive Director, Innovative Health Initiative (IHI)

“CDISC is honoured to be part of the c4c project and participate in this ground-breaking work,” said Rhonda Facile, VP, Partnerships and Development, CDISC. “The User Guide will assist the research community in leverage CDISC Standards to connect paediatric clinical trial data and create submission-ready data, expediting the review of safe and effective treatments for children.”

A team consisting of CDISC standards experts, paediatric clinical research experts from CDISC member organizations and paediatric subject matter experts from the c4c consortium developed the User Guide following CDISC’s consensus-based, standards development process. User Guide Topics include participant and participants’ family information (e.g., medical conditions, reproductive, diet and nutrition, body system assessments), pregnancy and birth, study conduct.

The User Guide is integral to the work undertaken by the c4c consortium.



CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization with administrative offices in Austin, Texas, and Brussels, Belgium and thousands of employees, volunteers, and member organizations around the world.

CDISC is a third party of Newcastle University within the c4c consortium.

About c4c

“Better medicines for babies, children and young people through a pan-European clinical trial network”

c4c (conect4children) is a large collaborative paediatric network that aims to facilitate the development of new drugs and other therapies for the entire paediatric population in Europe.

It is a pioneering opportunity to build capacity for the implementation of multinational paediatric clinical trials whilst ensuring the needs of babies, children, young people and their families are met.

c4c endeavours to provide a sustainable, integrated infrastructure for the efficient and swift delivery of high-quality clinical trials in children and young people across all conditions and phases of the drug development process.

By emphasizing inclusiveness and collaboration across geographical, specialty, sectoral, cultural and societal backgrounds, c4c will improve infrastructure to support the development of medicines for children.

For further information, please follow the link below to the c4c website:


About the c4c Consortium

The c4c research Consortium brings together pharmaceutical companies, paediatric national networks as well as EU multinational sub-speciality networks, large patient advocacy groups, children’s hospitals and other public research organisations from across Europe. The project consortium is a novel collaboration between academic and private sectors that include 35 academic and 10 industry partners from 20 European countries. The full list of organisations involved in the project can be found at the c4c webpage

A list of c4c beneficiaries is available to view here:


About Innovative Medicines Initiative and c4c

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU), Europe’s biggest Public-Private Partnership, under grant agreement No 777389. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA (the European Federation of Pharmaceutical Industries and Association).



This communication reflects the views of the c4c Consortium and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein.

H2020-JTI-IMI2-2016-10. Proposal: 77738

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