OpenEDC 1.3 is here 🎉 To the blog post →

The
  • simple
  • secure
  • modern
  • simple
software for clinical trials

A validated system for clinical trials with a focus on user-friendliness, collaboration and data protection. Fully GCP and GDPR compliant.

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The OpenEDC Cloud is available now!

Developed in Germany, hosted in the Telekom Cloud or On-Premises. Request a free demo.

Application areas

From thesis to clinical trial

OpenEDC is the ideal solution for all types of research projects. From surveys during a doctoral thesis, to clinical outcomes study, to multi-centric studies. The modular concept allows the solution to be customized for every requirement.

Application areas

Clinical trials

OpenEDC supports clinical research organizations (CROs) as well as medical device and pharmaceutical manufacturers in conducting clinical trials with a validated system. Fully AMG, MPG, DSGVO, GCP and HIPAA compliant.

Outcomes studies

Clinics and practices can use OpenEDC to evaluate and continuously improve the outcome of their therapies. An app for patients allows user-friendly and digital follow-up. Interactive statistics provide insights in real time.

Registers

OpenEDC enables university hospitals, institutes and other research institutions to conduct large longitudinal and multi-centric trials such as registries and epidemiological studies. With the option of distributed data storage.

Doctoral thesis

Students and individual researchers can use OpenEDC locally on their own computers – without installation or registration. Surveys are easy to set up in compliance with the data protection regulations.

Features

A Variety of opportunities

OpenEDC offers you all the essential functions to implement your research project quickly and easily.

Simple form creation

OpenEDC offers an interactive, easy-to-understand form editor. Type in questions and pre-defined answer options in a natural way. See what the finished form looks like at any time. Create multilingual forms with real-time validations, branching / conditional logic, file uploads and much more.

OpenEDC Screenshot

Reports and insights

OpenEDC allows you to create powerful, highly interactive reports. Simply filter data with one click and combine multiple filters until you see the data selection you want. You can then easily export this selection, analyze it further with other statistical tools or share it with colleagues.

OpenEDC Screenshot

Compliant with GCP

OpenEDC complies with all legal requirements of Good Clinical Practice (GCP). View the audit trail that records all changes in the data set. Create, assign and monitor queries for the highest data quality. And use the granular roles and rights system to define user access permissions.

OpenEDC Screenshot

Surveys for ePRO and eCOA

You can send surveys as a link or QR code in a matter of seconds and thus collect electronic patient-reported outcomes (ePROs or eCOA). This allows you to focus on patients and collect data from the participants' perspective. This can be used for patient diaries at regular intervals, too.

OpenEDC Screenshot

Calender and visits

With the calendar module, everyone in your team can create and manage shared or personal dates to keep everyone up to date. In longitudinal studies, the next visits for each subject are automatically displayed in the calendar - this enables central and efficient organization without any manual planning.

More features

OpenEDC offers many features to support you with your study.

Pseudonymization

Manage all participants of your trial – also completely pseudonymized if required.

Randomization

Coming soon: Different methods for the automatic randomization of subjects.

Document management

Revision-proof documents for patient consents, SOPs, wikis or similar.

Multi-center studies

Creation and management of multiple sites for distributed, multi-center studies.

Events and visits

Grouping of related forms for longitudinal studies and research projects.

Repeating data

Patient diaries or medication lists with an arbitrary number of repetitions.

Excel und CSV Import

Existing data can be cleansed, standardized and imported during a guided process.

Reason for change

Specifying a reason for data changes - in accordance with the GCP regulation.
OpenEDC Teamphoto

Vision

Our vision

We want to be far more than just an EDC system. With OpenEDC, we want to create a research platform that allows everyone around the world to use our product in a few seconds without lengthy sales loops, registration obligation or necessary expert knowledge. We strive to enable the collection of more qualitative data, the connection of data and, ultimately, the improvement of medical care.

References

Practical experiences

We are advocates for academic research and provide institutes with an open, customizable and flexible solution for diverse research projects.

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“The major advantages of OpenEDC for us are user-friendliness, extensibility and interoperability. By supporting the CDISC ODM data standard, we can export and import both metadata and clinical data in a widely recognized format.”

Prof. Dr. Martin Dugas
University Hospital Heidelberg
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“Decentralized data storage and record linkage is a vital factor for us. We use it to implement federated projects without disregarding the needs of the participating sites. Each clinic retains control over its data – and yet comprehensive monitoring is possible with OpenEDC.”

Prof. Dr. Julian Varghese
University Hospital Münster

Get in contact

Would you like to conduct your study simply, securely and efficiently? Then get in touch and we will be happy to present OpenEDC to you.