Trial Solutions

Improving catchment, diversity, and follow-up

Hawthorne Effect’s proven solution brings new medical devices, pharmaceuticals, and therapies to market with better speed and outcomes

Hawthorne Effect solves for the biggest trial challenges

Distance and time can combine to create patient access limitations and exacerbate attrition, which result in non-representative subject populations and missing data - ultimately jeopardizing regulatory approvals and market adoption.

Complexity Unlocked

The Hawthorne Effect Trial Solution

Complex, Distributed Visit Orchestration

We ensure comprehensive investigator oversight by leveraging proprietary, transformational technology to automate complex orchestration and manage distributed touchpoints. The Hawthorne Cloud provides the building blocks to deliver real-time, validated, and highly accurate data for any clinical trial.

In-Person Clinical Touchpoints

We then match complex trial needs to trained and qualified medical professionals, whether leveraging the growing Hawthorne Hero network of 4K+ clinicians or augmenting with your network, to focus on the patient journey.

Cutting-Edge Mobile Assessments

Hawthorne collects the highest quality data by deploying cutting-edge portable technology to perform assessments anywhere and enabling reliable data validation and interpretation.

Increased Patient Access

Expanded geographic catchment areas and patient enrollment from anywhere – even for those with limited mobility

Enabled Investigators

Standardized operations and consistent data quality and capture, extending research to new community providers

Improved Data Quality

Cleaner, faster, representative data that accelerates regulatory submissions and market introduction

Our PROOF

Case Studies

IMPROVED DATA QUALITY & RELIABILITY

Rare disease pharmaceutical study

Hawthorne Effect was brought in as a rescue partner and enabled completion of a Phase III rare disease (recurrent pericarditis) drug trial, leading to FDA approval during a worldwide pandemic.

Study Insights

COVID-19 shelter-in-place prohibited patient follow-up
Hawthorne completed the primary endpoint visit for 40% of patients
Published results in the NEJM during the pandemic
96% reduction in the risk of recurrent pericarditis episodes
Received orphan drug designation for the treatment of recurrent pericarditis

Days to complete

Academic sites

Months from last visit to FDA approval

Increased Patient Access

Valvular heart disease prevalence study (PREVUE-VALVE)

In this cardiovascular prevalence study with the Cardiovascular Research Foundation, Hawthorne Effect provided access to representative target populations and accelerated enrollment.

Study Insights

Collaboration with retail health and academia
HE single site and end-to-end patient journey
Eliminated need for 100 sites with one virtual site
500 subject pilot enrolled in four months
5,000 patient trial underway
15% participant age of 80+

0 %

African American representation (<5% average)

0 %

Asian American representation (1.6% average)

0 %

Hispanic representation (1.0% average)

Enabled Investigators

Medical device pivotal trial for tricuspid regurgitation

Hawthorne Effect was a key player in this study for symptomatic patients with severe tricuspid regurgitation who were at greater estimated risk for mortality with tricuspid valve surgery. We helped to accelerate enrollment and enable key sites to exceed recruitment targets.

Study Insights