Data Management Platform

Trusted Clinical Data - Innovative, Secure, Standardised, and Compliant

The SCTO Data Management Platform is building a strong foundation for clinical data management in Switzerland. Its goal is simple: To ensure that researchers can rely on high-quality data for trustworthy results.

To achieve this, the Platform is developing secure, standardised, and compliant solutions based on globally used standards. It is also creating innovative tools that keep pace with technological advances. By harmonising processes across institutions, the Platform makes it possible to compare, combine, and use data collected in different settings to deliver reliable results.

Focusing on data excellence, the Platform lays the foundation for a future-ready research infrastructure that advances patient care in Switzerland.

The Data Management Platform has defined four main objectives for 2025–2028, supported by strategic projects.
We invite you to contact us at datamanagement@scto.ch if you would like to learn more.

Improve Harmonisation, Quality, and Efficiency of Data Management

CDISC Standards & Protocol-to-CRF/eCRF Automation
This project focuses on implementing Clinical Data Interchange Standards Consortium (CDISC) standards in electronic Case Report Forms (eCRFs). It explores innovative approaches to automate CRF/eCRF creation using the ICH M11 Clinical electronic Structured Harmonised Protocol (CeSHarP) and the open-source tool OpenStudyBuilder, which facilitates structured and standardised study design.

The long-term vision is to enable a fully digital data flow from protocol development to eCRF design, following the “define once – reuse many times” principle.

Key goals:

Develop ready-to-use CRF/eCRF templates in the CDISC format for consistent, high-quality data collection across studies
Explore automation of the protocol-to-eCRF process using ICH M11 CeSHarP and OpenStudyBuilder
Publish a proof-of-concept report on CRF/eCRF automation
Organise workshops on automation, use of CDISC standards, and best practices

Establish a Compliant eConsent Solution

We are designing a secure eConsent solution for academic clinical research, based on a standardised yet adaptable framework (REDCap® eConsent framework).

Key goals:

Design a compliant eConsent workflow
Test in pilot studies
Collect stakeholder feedback
Publish a process guide and a project template
Provide training and webinars
Continuously improve based on implementation feedback

SPHN Scientific Tools

This project aims to assess how Swiss Personalized Health Network (SPHN) scientific tools can best be applied in clinical research, with particular attention to studies with limited data management capacity.

Key goals:

Build foundational knowledge of SPHN scientific tools
Evaluate requirements, simplicity, and practicability of integrating these tools into data management workflows at Clinical Research Centres (CRCs)
Explore use cases and proof of concept for applying SPHN scientific tools within SCTO Data Management Platform
Offer recommendations and guidelines
Collaborate with SPHN Data Coordination Centre (DCC) and local Clinical Data Warehouse (CDWH) teams

Advance Training and Education in Data Management

This initiative will provide study teams with targeted training in Clinical Data Management Systems (CDMS) and best practices in data management to further strengthen research quality and efficiency.

Key goals:

Develop practical resources, including tutorial videos & guidelines
Demonstrate core CDMS functionalities
Promote continuous learning across the network

We welcome your input to help shape this training initiative. If there are specific topics or areas where additional data management training would be valuable, please share your suggestions with us: datamanagement@scto.ch.

Discover recent Data Management Platform projects and access available tools in the SCTO Tools & Resources Navigator at the top of this page.

From secuTrial® Data Exports to Analysis-Ready Data — Fast and Reproducible

secuTrialR – An R Package for Transforming secuTrial® Data Exports into Analysis-Ready Datasets

secuTrialR is an open-source R package that facilitates the parsing, reading and preparation of data collected in the clinical data management system secuTrial®. It helps to format dates, times, and categories, reducing the effort required for data processing and analysis.

The package also offers built-in functions to quickly generate descriptive statistics, such as recruitment figures and the completeness of secuTrial® forms.

Access the package

If you use and benefit from secuTrialR in your work, please cite it as: Wright, P. et al. (2020). secuTrialR: Seamless interaction with clinical trial databases in R. The Journal of Open Source Software 5(55): p. 2816. https://doi.org/10.21105/joss.02816.

Data Visualisation and Study Oversight

shinytemplate is a ready-to-use Shiny app template for clinical trials and research. Intermediate R users can customize it by enabling/disabling modules and adding their own data. Provided as an R package, it ensures an organised framework for development, maintenance, and sharing.

The app includes modules for recruitment, retention, data quality, study management, and safety monitoring, with visual tools such as plots, maps, flow charts, and reports to track study progress. Detailed instructions on deployment and customisation are provided here: Go to tool.

Contact your Data Manager for details.

Infrastructure and Strategy Development

Assessment of technical options, stakeholder needs, and regulatory considerations to develop a validated concept for a shared SCTO CDMS.

Report unpublished, available upon request: datamanagement@scto.ch.

Routine Data Supporting Clinical Research

Routine data integration projects standardise care data for research, addressing harmonisation, governance, linkage, and tooling.

This project assessed how clinical data warehouses (CDWH) can enable more consistent and efficient use of hospital routine data in clinical research. Building on national initiatives like SPHN and improving standard research tools will further ease the use of real-world data in future studies. The outcomes, though not publicly available, inform our objectives. for 2025-2028.

Report unpublished, available upon request: datamanagement@scto.ch.

Standardised and Compliant Safety Data Collection

Standardised eCRFs for AE/SAE documentation in secuTrial® and REDCap®, aligned with CDISC and swissethics.

Standardised electronic Case Report Forms (eCRFs) for documenting Adverse Events (AEs) and Serious Adverse Events (SAEs) in secuTrial® and REDCap®. These forms are aligned with swissethics requirements and based on internationally used standards (CDISC CDASH).
(Internal validation ongoing)

MedDRA Coding in SecuTrial®: A Validated Solution From Free Text to Structured Safety Data

This validated tool enables direct coding of Adverse Events and Medical History within secuTrial® databases using MedDRA. Instead of searching the MSSO Web-Based Browser and copying terms manually, coding is performed directly in secuTrial®—saving time, reducing errors, and keeping all trial data in one place.

Freely available across the SCTO CRC Network, the tool supports more efficient, interoperable, and reliable clinical research. For integration of MedDRA coding into your database, please contact us (datamanagement@scto.ch) or your CRC Data Manager.

MedDRA Coding in secuTrial®: A Validated Solution

Meet the Platform Team

Meet the individuals whose expertise and collaboration drive each Platform forward. Together, they help strengthen clinical research across Switzerland through shared knowledge, leadership, and innovation.

Team Members

Tanja Litke – Coordinator, DKF Basel
Marielle Rutquist– Member, DKF Basel
André Brunella – Contributor, DKF Basel
Patrick Simon – Contributor, DKF Basel
Pia Neuschwander – Contributor, DKF Basel
Khaled Mostaguir – Member, CRC Geneva
Laurent Brodier – Contributor, CRC Geneva
David Droz– Contributor, CRC Geneva
Didier Glauser– Contributor, CRC Geneva
Laura Juan– Contributor, CRC Geneva
Laura Urbini – Contributor, CRC Geneva
Fady Fares – Member, CRC Lausanne
Vassili Soumas – Contributor, CRC Lausanne
Francesco Acquati – Contributor, CRC Lausanne
Antje Thien – Member, CTC Zürich
Stephan Benke-Bruderer – Contributor, CTC Zürich
Margarida Brandenberg – Contributor, CTC Zürich
Lucien Gyger – Contributor, CTC Zürich
Lisette Paratore – Contributor, CTC Zürich
Monika Poppe – Contributor, CTC Zürich
Miriam Olombrada Sacristan – Contributor, CTC Zürich
Karin Huber – Contributor, CTC Zürich
Andre Hoepli – Member, CTU HOCH St.Gallen
Lynn Radamaker – Contributor, CTU HOCH St.Gallen
Peter Schoeneberger – Contributor, CTU HOCH St.Gallen
Yves Franzosi – Member, CTU-EOC Lugano
Luca Clivio – Contributor, CTU-EOC Lugano
Agatha Wisse – Member, DCR Bern
Anna Glenck – Contributor, DCR Bern
Dominik Guentensperger – Contributor, DCR Bern
Alan Haynes – Contributor, DCR Bern
Muriel Helmers – Contributor, DCR Bern
Kimberly Gilbert – Contributor, DCR Bern
Flurina Jenal – Contributor, DCR Bern
Eva Joho – Contributor, DCR Bern
Lucia Kacina – Contributor, DCR Bern
Ursula Thormann – Contributor, DCR Bern
Christiane Pelzer – Contributor, DCR Bern
Sheila Appadoo – Contributor, DCR Bern
Jens Schulenburg – Voluntary Contributor, Swiss Cancer Institute
Corinne Ackermann – Voluntary Contributor, Schweizer Paraplegiker- Zentrum
Laurence Chapatte – Scientific Affairs Manager & Liaison Officer, SCTO

Tanja Litke

Coordinator, DKF Basel

Fady Fares

Member, CRC Lausanne

Yves Franzosi

Member, CTU-EOC Lugano

Agatha Wisse

Member, DCR Bern

Andre Hoepli

Member, CTU HOCH St.Gallen

Khaled Mostaguir

Member, CRC Geneva

Marielle Rutquist

Member, DKF Basel

Antje Thien

Member, CTC Zürich

Laurence Chapatte

Scientific Affairs Manager & Liaison Officer

Other Platform Contributors

Team Members

Laurence Chapatte – Scientific Affairs Manager & Liaison Officer
Antje Thien – Member, CTC Zürich
Marielle Rutquist – Member, DKF Basel
Khaled Mostaguir – Member, CRC Geneva
Andre Hoepli – Member, CTU HOCH St.Gallen
Agatha Wisse – Member, DCR Bern
Yves Franzosi – Member, CTU-EOC Lugano
Fady Fares – Member, CRC Lausanne
Tanja Litke – Coordinator, DKF Basel
Corinne Ackermann – Voluntary Contributor, SPZ
Francesco Acquati – Contributor, CRC Lausanne
Sheila Appadoo – Contributor, DCR Bern
Stephan Benke-Bruderer – Contributor, CTC Zürich
Margarida Brandenberg – Contributor, CTC Zürich
Laurent Brodier – Contributor, CRC Geneva
André Brunella – Contributor, DKF Basel
Luca Clivio – Contributor, CTU-EOC Lugano
David Droz – Contributor, CRC Geneva
Kimberly Gilbert – Contributor, DCR Bern
Didier Glauser – Contributor, CRC Geneva
Anna Glenck – Contributor, DCR Bern
Dominik Guentensperger – Contributor, DCR Bern
Lucien Gyger – Contributor, CTC Zürich
Alan Haynes – Contributor, DCR Bern
Muriel Helmers – Contributor, DCR Bern
Karin Huber – Contributor, CTC Zürich
Flurina Jenal – Contributor, DCR Bern
Eva Joho – Contributor, DCR Bern
Laura Juan – Contributor, CRC Geneva
Lucia Kacina – Contributor, DCR Bern
Pia Neuschwander – Contributor, DKF Basel
Miriam Olombrada Sacristan – Contributor, CTC Zürich
Lisette Paratore – Contributor, CTC Zürich
Christiane Pelzer – Contributor, DCR Bern
Monika Poppe – Contributor, CTC Zürich
Lynn Radamaker – Contributor, CTU HOCH St.Gallen
Peter Schoeneberger – Contributor, CTU HOCH St.Gallen
Jens Schulenburg – Voluntary Contributor, Swiss Cancer Institute
Patrick Simon – Contributor, DKF Basel
Constantin Sluka – Contributor, DKF Basel
Vassili Soumas – Contributor, CRC Lausanne
Ursula Thormann – Contributor, DCR Bern
Laura Urbini – Contributor, CRC Geneva