Synthetic Control Arm

Phesi’s data-driven approach enables you to gain deeper understanding of your patient populations and identify the best use cases for a synthetic control arm.

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Synthetic COVID-19 Patient Profile
Our service

Improving clinical development with synthetic patient data

In traditional clinical studies, patients are often unnecessarily exposed to a placebo comparator arm. Placebos increase the burden on both patients and sites. They are not only associated with ethical challenges, but also require higher numbers of patients to complete trials.

Working towards reducing and ultimately eliminating the use of placebo comparator arms should be an industry-wide goal. Phesi works to support this aim with the use of synthetic data via an integrated and systematic approach. Synthetic data is collated from similar or identical trials using the same agent, with real-world patient data, to accurately model comparator outcomes while accelerating development.

Our approach

Reveal deep insight into patient populations

At Phesi, we empower you to use synthetic patient data to define the boundaries of a trial, to model and predict what types of patients should be included and excluded, and to understand which trials are salvageable. We help you to identify the best candidates for a synthetic control arm and provide guidance on implementation. This will enable you to answer questions, including:

What would the potential side effect profiles be for the control group?

What would the clinical outcomes look like for the control group?

Will the inclusion/exclusion criteria help enroll the correct patient population for my trial?

How can I minimize patient and site burden in the trial? As well as minimising ethical issues around the use of placebos?

Our strengths

Accelerate clinical trials with synthetic control arms

Phesi is a pioneer in this field. We have been using synthetic patient data to aid clinical trial planning and operations for more than a decade. Phesi has curated a large clinical trial database of approximately 30 million patient records from an estimated 330,000 global clinical trials across nearly 200 countries, and with access to over 6.1 million patient records from hospital settings. Through clinical trial investigator site management tool ClinSite® clients can also apply the accumulated patient data to optimize Target Patient Profiles (TPP).

This data enables Phesi to quickly model a clinical study all the way from early screening, to protocol design, to removing a comparator arm – addressing the long-standing challenges in the drug discovery process and accelerating the route of treatments to patients.

Case studies

Patient recruitment for melanoma immunotherapy trial

Other services

Protocol Design and
Optimization

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Strategic Development
Planning

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Ongoing Trial
Support

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    our clients

    Customer experience

    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 TEKADA

    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 tekada