Protocol Design and Optimization

Our service

Empowering you to transform clinical development

Phesi understands that unexpected clinical trial results can be costly and time-consuming. Studies that are poorly designed impact on expenditure and timeframes, and can ultimately lead to a trial’s failure. Ineffective trial design also delays the speed at which new therapies can reach patients. At Phesi, we apply our deep domain knowledge and integrated clinical data science approach to help you optimize your protocol design.

Our systematic and integrated approach unlocks the value of data. We provide scalable, predictive and automated real-time analytics that will accelerate your drug development projects, overcome recruitment challenges, and create patient-centric trials that deliver results.

Our approach

Unleash insights from data, reduce costs, and accelerate trials

By systematically reviewing relevant trial data, including protocol designs and amendments, we help you model baseline patient characteristics for a planned clinical trial to ensure your trials are patient-centric. This enables you avoid common pitfalls made when setting inclusion/exclusion criteria, and the selection of primary and secondary outcomes, while identifying gaps in statistical analysis plans. We help you:

Achieve desired results from protocol design
Reduce the number of protocol amendments
Reduce costs and accelerate trial timelines
Deploy synthetic trial arms
Decrease the patient and site burden
Understand the competitor landscape
Accurately predict enrollment cycle time
Simplify “what if” analysis with predictive modelling

Our strengths

Unparalleled access to data drives successful development

Phesi’s AI-powered Trial Accelerator™ advanced clinical data analytics platform, including our ClinSite® product, 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 Product Design and Protocol 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:

Synthetic 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

Cardiovascular study protocol feasibility

Strategic Development
Planning

Ongoing Trial
Support

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.

FORMER SVP, GLOBAL CHIEF MEDICAL OFFICER AND US R&D HEAD Sanofi

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.