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Hawthorne Effect Completes $20 Million Series A Round of Financing to Decentralize Clinical Trials

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Hawthorne Effect Completes $20 Million Series A Round of Financing to Decentralize Clinical Trials | Pharmtech Focus

Hawthorne Effect™, a solution for decentralizing clinical trials, today announced the successful closing of a $20 million Series A round of funding to alleviate key issues related to patient recruitment and retention via its tech-driven platform and expansive network of medical professionals. The funding will be used to accelerate growth and help scale the company’s operations. The new investment brings the company’s total funding to $24 million and was led by Northpond Ventures, a leading science and technology-driven venture capital firm, with participation from SignalFire and P5 Health Ventures.

Hawthorne Effect’s solution decentralizes the entire lifecycle of a clinical trial by leveraging a robust tech-driven platform, the Hawthorne CloudSM, and highly-trained medical professionals, Hawthorne HeroesSM. The end-to-end solution enables Hawthorne Effect to conduct complete assessments whenever, wherever and however the trial and patient require to deliver trusted and timely data to the investigators. Hawthorne Effect benefits patients by creating convenient access to participation and improves the quality and efficiencies to trial sponsors by broadening patient pools, speeding up recruitment, conducting consistent assessments and improving data quality. See details on the components that make up Hawthorne Effect below:

●  Hawthorne CloudSMThe 21CFR, GDPR-compliant platform has been used to complete more than 25,000 assessments in more than 15,000 in-person or virtual visits for over 50 clinical trials across a wide variety of therapeutic areas and phases. Its novel architecture manages all aspects of the clinical trial journey for patients and investigators from recruitment through study exit, including clinical assessment development; visit choreography; data acquisition via patient-reported outcomes; devices; interoperability with health system databases and directly from all forms of clinical visit modalities (in-person, via telepresence and in remote geographies).

●  Hawthorne HeroesSMHawthorne Effect’s robust specialty network of multi-disciplinary medical professionals is made up of more than 2,200 highly-vetted and highly-trained Hawthorne HeroesSM. Heroes are geographically distributed in North AmericaEurope and Africa to deliver compassionate care to patients. They are equipped to facilitate complex assessments and support the patient experience throughout the study lifecycle. Capabilities include complex clinical and physical treatments and assessments such as medical histories; consenting; ultrasound imaging; neurological, cognitive and functional assessments; complex blood draw and sample management; adverse event reporting and more. These medical professionals shape the future of medicine by playing a role in clinical trial research that enables them to have an impact on individual patients while improving health care for humanity.

While clinical trial continuity has always been a challenge, the COVID-19 pandemic accentuated this problem with a temporary 70% decline in enrollment and an increased rate of missed or incomplete study visits. Critical trials can require more than 10,000 visits and 100,000 assessments to collect the necessary safety and effectiveness endpoints required for FDA approval. At least 90% of these visits require professional conduct and all of them are needed for meaningful analyses and regulatory review. While studies have increasingly gone virtual as a result of the pandemic, trials that require complex visits such as cardiac ultrasound and blood draws are seriously at risk for continuity and completion. Hawthorne Effect uniquely offers end-to-end visits and study management for both virtual and complex visits as well.

Hawthorne Effect addresses key risk factors that will extend well beyond the pandemic including patient churn, missed assessments and lack of diversity in patient pools. Hawthorne Effect mitigates these factors by conducting trial assessments anywhere, whether it be virtual or at a home, church, shelter or clinic, and can maintain the highest levels of protocol integrity and improve data quality compared to site-reliant trials.

“We figured out that clinical trial continuity has the same root cause as equity gaps in health care delivery — accessibility and convenience for patients,” said Jodi Akin, CEO and founder of Hawthorne Effect. “While there is great momentum in the adoption of decentralized clinical trials, apps just don’t draw blood, nor do they reach the equity divide. Hawthorne Effect uniquely offers the only technology-enabled distributed professionals model that addresses these common barriers in clinical research. As a result, we help sponsors deliver complete and accurate trial assessments to benefit the entire clinical trial ecosystem. Our solution also addresses the historical disparities in representation when it comes to patient populations, and the future of public health hinges on closing this gap.”

“Hawthorne Effect is bringing the future of clinical trials to life with a solution rooted in scientific precision and clinical compassion,” said Sharon Kedar, CFA, co-founder and partner of Northpond Ventures. “The team is reimagining accessibility to clinical trials and driving better data integrity – all while putting the patient first.”

Since launching in 2015, the Hawthorne Effect solution has been used across more than 50 clinical trials, of which 99% of visits and assessments were completed within the trial window, even for the most complex of visit requirements. Hawthorne Effect is actively engaged with more than 260 clinical sites and also runs trials as a single virtual site. Hawthorne Effect is collaborating with NIH Operation Warp Speed COVID-19 clinical trials and works with some of the largest names in health care and pharmaceuticals. 

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