The lack of standardized data in Clinical Operations (ClinOps) poses challenges for interoperability between Clinical Trial Protocols and Operations systems. Manual transcription of protocol information by pharmaceutical companies and Contract Research Organizations (CROs) results in ambiguous data, necessitating multiple rounds of review and causing delays throughout the process.

Project Deliverables

1. Enhanced Interoperability: Improving communication between systems for seamless data sharing.
2. Enhanced Data Quality: Establishing standards for accurate and consistent clinical trial data.
3. Cost Savings: Integrating data efficiently to reduce manual efforts and costs.
4. Improved Decision-Making: Enabling stakeholders to make informed decisions for better clinical trial management.

What will the project achieve?

Establishing coherent data standards is crucial for translating protocol information into executable clinical operations, ensuring consistency and clarity while reducing ambiguity and errors. The project seeks to identify use-cases and competency questions in Clinical Operations, showcasing the advantages of a semantic approach for improving system interoperability and task execution efficiency.

How will the project do this?

The project will utilize existing resources and a Business Process Ontology to develop a semantic data model for clinical operation protocols. Foundational work has begun, focusing on enhancing this groundwork at a semantic level. Early evaluation, especially regarding the Business Process Ontology, will aid in translating protocols into detailed execution procedures. Various sources will be used to provide extensive terminology for representing clinical trials. Initial focus will be on site feasibility, with evaluation of data sources for potential integration into the ontology.


Our Supporters

Thanks to the companies who are making this community possible, without their help this community would not exist or collaborate.

Project Steering Team


Project Champions

  • Merck KGaA: Gernot Weber, Hrvoje Mohoric, Stefan Gilb
  • Roche: Marcel Merfort, Cedric Berger
  • Novartis: Artur Schaf, Rudi Ager
  • Boehringer Ingelheim: Karsten Quast


Project Management

  • Aditya Tyagi (PM)
  • Thierry Escudier (Portfolio Management)
  • Christian Baber (Chief Portfolio Officer)