The landscape of clinical trials is evolving rapidly, with innovations in treatment modalities and personalized medicine. However, this advancement comes with its own set of challenges. The increasing complexity of clinical trials, lack of standardization, and reliance on non-machine-readable data formats hinder the seamless flow of information and integration of cutting-edge AI technologies in clinical trial operations. These challenges lead to inefficiencies, potential for error, and delays in the delivery of critical therapies to patients.

Why is this important?

  • Complexity: Clinical trials are becoming more intricate due to diverse protocols and endpoints, which can cause operational bottlenecks.
  • Lack of Standardization: Disparate processes and documentation styles across trials and organizations lead to inconsistencies and miscommunication.
  • Data Format: Essential data is often locked in formats that are not conducive to AI and machine learning technologies, slowing down the potential for insights and advancements.


Hear directly from our Project Manager, and clinical operations expert, Aditya Tyagi about the purpose and intention for this new developing project.


Introducing Clinical Operations Project and Aditya Tyagi, Project Manager for Pistoia Alliance


What will the project achieve?

  • Efficiency: Minimizing human error with standardized protocols and AI assistance.
  • Accuracy: Minimizing human error with standardized protocols and AI assistance.
  • Insight:Enabling deeper analytical insights through advanced data processing capabilities.
  • Adaptability:Keeping pace with the evolving landscape of clinical research and regulatory requirements.


The ClinOps-O project is not just an upgrade; it’s a necessary evolution in clinical trial operations. By embracing standardization and the power of AI, we can overcome the current operational challenges and pave the way for a future where clinical trials are more efficient, accurate, and insightful. Join us in revolutionizing clinical operations for the betterment of patients and the acceleration of innovative therapies.


How will the project do this?

The ClinOps-O project is our attempt in response to these challenges. It is designed to transform clinical operations by standardizing the execution of tasks and documenting them in a machine-readable ontology.

  • Standardized Task Execution: Establishing unified protocols for common clinical operations tasks, such as operational site feasibility, to facilitate consistency and quality across trials.
  • Machine-Readable Ontology: Implementing a structured, machine-readable format for all documentation, enabling the swift and accurate interpretation of data by AI systems.
  • AI Integration: Leveraging AI technologies to automate routine tasks, predict outcomes, and enhance decision-making processes.
  • Scalability and Flexibility: Designed to accommodate the diversity of clinical trials, from small-scale early-phase studies to large, multi-site phase III trials.
  • Compliance and Security: Ensuring that all data handling is in strict adherence to regulatory standards, with robust cybersecurity measures in place.


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)
  • Asiyah Yu Lin, Ontologist and Data Scientist


Project Execution

  • Crownpoint Technologies