Protocol Design and Optimization

Make patient-centric protocol design your path to more efficient clinical trial execution and get effective treatments to patients faster.

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Empowering you to transform clinical development

As the global leader in patient-centric data analytics, Phesi can help you design better protocols from the outset and avoid costly amendments across your clinical development portfolio, resulting in shorter cycle-times and faster cures.


Using patient data to design smarter trials

Patients are at the heart of our protocol design optimization services. With the world’s largest clinical development database and our proven integrated approach to clinical data science, we provide insight from 70 million patients to inform and improve the success of your trials. 

Let us help you target the right patients and make fast and accurate decisions resulting in:

  • Cost reduction and faster trial timelines 
  • Reduced patient burden  
  • Fewer protocol amendments
  • A greater understanding of the competitor landscape
  • Accurate enrollment cycle time predications
  • Fewer non-performing sites  
  • Simplified ‘what if’ analysis with our predictive modelling 
  • Development of Digital Twins and Digital Control Arms  

Unparalleled access to data drives successful development

Phesi’s AI-powered Trial Accelerator™ advanced clinical data analytics platform, collects and analyzes live data from more than 4,000 diseases. It includes trial and site information from 485,000+ trials, including more than 600,000 principal investigators in nearly 200 countries. By applying our proprietary integrated data science approach and advanced protocol design analytics to this data, we drive successful clinical development and commercialization.

Planning a clinical study means answering a lot of questions. Phesi’s access to such a volume of data removes guesswork. Allowing you to make decisions based wholly on insights from data, confidently and quickly. Including:

What are the key modal values required in this protocol for my trial to be successful?

How many sites should I activate and where should they be located?

What is the estimated enrollment cycle time?

How can I reduce the number of protocol amendments?

How can I align better with my CROs and partners?

Our methodology

The Four Pillars of Protocol Design and Trial Optimization

Our unique methodology ensures you benefit from real-time data science, supported by Artificial Intelligence and Machine Learning, in whatever therapeutic area you are studying – including rare diseases. Our four pillared approach covers:

Digital patient profile from the same indication and commercial analysis: Using real-world data to create a synthetic patient profile; maximizing patient participation and optimizing data collection.

Modal values from similar, completed and ongoing trials: Integrated trial design optimization using historical design data to define modal values for inclusion/exclusion criteria, endpoints, treatment duration and comparator(s).

Track protocol amendment records to identify design vulnerabilities: Dynamic protocol amendment tracking to identify design elements that are susceptible to change and minimize costly amendments.

Relationships between design and operational execution: Use Gross Site Enrollment Rate (GSER) model to bridge between trial design and operational implementation; quantitatively define operational impacts from specific design elements to maximize success.

Case studies

Protocol Design and Investigator Site Selection: Follicular Lymphoma

Other services

Strategic Development

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Ongoing Trial

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Digital Twin &
Digital Trial arm

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    Our clients

    Customer experience

    Phesi is on the frontiers of defining clinical development as a science, performing systematic analysis of the clinical trial, clinical protocol, and clinical site space to form hypotheses about what will work and what will not. Through observation and experiment you are applying those learnings to inform new clinical programs or save old ones. Phesi is more than the sum of its parts and the value is in the integration.


    Every global R&D leader should know about this and should be testing it within their portfolio.

    senior director, clinical operations Takeda

    Phesi worked with us to show that a particular adaptive trial design would give the best performance. The result was a significantly quicker and cheaper devel­opment time on this priority asset.

    senior director, clinical operations Takeda