Press release

Curebase and Persephone Biosciences Partner in Clinical Trial of Colorectal Cancer Among Diverse Populations

SAN FRANCISCO, Jan. 11, 2022 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, and Persephone Biosciences, a privately held company investigating the human microbial ecosystem's effect on therapeutic treatment, today announced a collaboration for the long-term clinical study of patients with colorectal cancer (CRC) to develop prevention strategies and better treatment options.

The decentralized clinical trial (DCT) involves collecting stool and blood specimens from 350 study volunteers with CRC, as well as 1,000 healthy people who are categorized as either low risk or high risk for the disease. A top priority of the ARGONAUT study and specifically the CRC patient arm, through a collaboration with Janssen Research & Development, LLC (Janssen), is to ensure at least half of participants are from diverse populations.

Participants who meet the entry criteria will provide two samples each of blood and stool over a six-month period. Follow-up appointments will be held at 12, 18, and 24 months to collect tumor scan results and additional updated medical data. Some trial participants will be monitored for up to eight years.

Curebase's decentralized clinical trial model ensures more diverse studies because unique populations – which typically are underrepresented in clinical trials – can be included. The company's virtual research sites also provide physicians with new and unique options to offer their patients, regardless of location. The Curebase platform empowers sponsors, CROs and physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites.

"A trial of this size, in which 50% of participants are planned to comprise racial and ethnic minorities, is unprecedented in both scale and ambition," said Dr. Stephanie Culler, co-founder and chief executive officer of Persephone Biosciences. "Curebase has helped Persephone secure community study sites throughout the U.S. that meet our diversity and inclusion criteria, while at the same time providing these sites with a DCT platform and virtual staff support that makes their participation in our trial easy. Together, I believe we are well positioned to better understand the role of the gut's microbiome in patient response to cancer therapies and, just as importantly, potentially to help create more equitable treatment outcomes for patients."

Curebase and Persephone are setting up more than 30 sites across the U.S. to recruit participants for the CRC study and collect patient electronic data. Participants are being given a convenient kit for producing an at-home stool sample, along with packaging and labeling material enabling easy pickup and shipping by FedEx.

Expected to begin early this year, this clinical trial is part of ARGONAUT, a longitudinal, observational study of 4,000 patients with advanced-stage cancer and healthy individuals with varying cancer risk. Importantly, the ARGONAUT study will enroll a diverse patient population, emphasizing patients from minority groups. The data collected may be used to develop precision microbiome medicines and to identify clinically actionable cancer-specific biomarkers for guiding therapeutic decisions. In addition to CRC, ARGONAUT will study non-small cell lung cancer, triple negative breast cancer and pancreatic cancer.

The results of the ARGONAUT study aim to provide a better understanding of the gut microbiome's role in patient response to cancer therapies, which in time may lead to the development of adjuvant therapeutics or a precision medicine approach to future oncology interventions, based on prior microbiome diagnostic testing. In addition, the potential discovery of biomarkers in the microbiome could enable earlier cancer detection and intervention.

"Diversity and inclusion in clinical trials is imperative for the rapid development of treatments that can help the most people," said Curebase founder and CEO Tom Lemberg. "We're excited to work with Persephone Biosciences on this landmark study that will provide researchers and clinicians with invaluable insights into treating and preventing colorectal cancer."

About Persephone Biosciences

Persephone Biosciences is committed to harnessing the role of the human microbial ecosystem to create better and more equitable therapeutics and diagnostics, and to aid disease prevention. Persephone's technology platform is based on diverse and inclusive, population-scale, observational clinical trials in conjunction with advanced multi-omics analyses and machine learning with the aim to probe the complex interaction between microbes and the immune system. Persephone develops precision immunotherapies utilizing synthetic biology for unmet needs and more equitable treatment outcomes.

About Curebase

At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up.

Media Contact:

Shawn Malloy

media@curebase.com

315-882-5310

Curebase and Persephone Biosciences Partner in Clinical Trial of Colorectal Cancer Among Diverse Populations

SAN FRANCISCO, Jan. 11, 2022 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, and Persephone Biosciences, a privately held company investigating the human microbial ecosystem's effect on therapeutic treatment, today announced a collaboration for the long-term clinical study of patients with colorectal cancer (CRC) to develop prevention strategies and better treatment options.

The decentralized clinical trial (DCT) involves collecting stool and blood specimens from 350 study volunteers with CRC, as well as 1,000 healthy people who are categorized as either low risk or high risk for the disease. A top priority of the ARGONAUT study and specifically the CRC patient arm, through a collaboration with Janssen Research & Development, LLC (Janssen), is to ensure at least half of participants are from diverse populations.

Participants who meet the entry criteria will provide two samples each of blood and stool over a six-month period. Follow-up appointments will be held at 12, 18, and 24 months to collect tumor scan results and additional updated medical data. Some trial participants will be monitored for up to eight years.

Curebase's decentralized clinical trial model ensures more diverse studies because unique populations – which typically are underrepresented in clinical trials – can be included. The company's virtual research sites also provide physicians with new and unique options to offer their patients, regardless of location. The Curebase platform empowers sponsors, CROs and physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites.

"A trial of this size, in which 50% of participants are planned to comprise racial and ethnic minorities, is unprecedented in both scale and ambition," said Dr. Stephanie Culler, co-founder and chief executive officer of Persephone Biosciences. "Curebase has helped Persephone secure community study sites throughout the U.S. that meet our diversity and inclusion criteria, while at the same time providing these sites with a DCT platform and virtual staff support that makes their participation in our trial easy. Together, I believe we are well positioned to better understand the role of the gut's microbiome in patient response to cancer therapies and, just as importantly, potentially to help create more equitable treatment outcomes for patients."

Curebase and Persephone are setting up more than 30 sites across the U.S. to recruit participants for the CRC study and collect patient electronic data. Participants are being given a convenient kit for producing an at-home stool sample, along with packaging and labeling material enabling easy pickup and shipping by FedEx.

Expected to begin early this year, this clinical trial is part of ARGONAUT, a longitudinal, observational study of 4,000 patients with advanced-stage cancer and healthy individuals with varying cancer risk. Importantly, the ARGONAUT study will enroll a diverse patient population, emphasizing patients from minority groups. The data collected may be used to develop precision microbiome medicines and to identify clinically actionable cancer-specific biomarkers for guiding therapeutic decisions. In addition to CRC, ARGONAUT will study non-small cell lung cancer, triple negative breast cancer and pancreatic cancer.

The results of the ARGONAUT study aim to provide a better understanding of the gut microbiome's role in patient response to cancer therapies, which in time may lead to the development of adjuvant therapeutics or a precision medicine approach to future oncology interventions, based on prior microbiome diagnostic testing. In addition, the potential discovery of biomarkers in the microbiome could enable earlier cancer detection and intervention.

"Diversity and inclusion in clinical trials is imperative for the rapid development of treatments that can help the most people," said Curebase founder and CEO Tom Lemberg. "We're excited to work with Persephone Biosciences on this landmark study that will provide researchers and clinicians with invaluable insights into treating and preventing colorectal cancer."

About Persephone Biosciences

Persephone Biosciences is committed to harnessing the role of the human microbial ecosystem to create better and more equitable therapeutics and diagnostics, and to aid disease prevention. Persephone's technology platform is based on diverse and inclusive, population-scale, observational clinical trials in conjunction with advanced multi-omics analyses and machine learning with the aim to probe the complex interaction between microbes and the immune system. Persephone develops precision immunotherapies utilizing synthetic biology for unmet needs and more equitable treatment outcomes.

About Curebase

At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up.

Media Contact:

Shawn Malloy

media@curebase.com

315-882-5310

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Digital Therapeutics Alliance and Curebase release publication setting the stage for a fit-for-purpose evidence standard for digital therapeutics (DTx)

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Health app companies wrestle with how to design studies to prove treatments work

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Curebase partners with Meru Health for 3-year mental health trial

Curebase signed a three-year clinical trial with Meru Health

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Curebase and Meru Health to Partner on Clinical Research for App-based Mental Health Treatment Program

Curebase and Meru Health announce partnership on three-year clinical trial.

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Curebase Names Digital Infrastructure Veteran Matt Lanier as VP of Engineering

Curebase welcomes Matt Lanier as VP of Engineering

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Y Combinator Top Private Companies - 2022

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Curebase Names Medical Research Veteran Sean Lynch as VP of Clinical Operations

Curebase welcomes Sean Lynch as Vp of Clinical Operations

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Curebase Hires Healthcare Attorney Laura Podolsky to Head Legal Team

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Curebase, Portamedic Partner to Support Decentralized Clinical Trials with Mobile Phlebotomy Services

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Curebase Hires Healthcare Technology Veteran Scott Garcia as Vice President of Finance

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Curebase, Flow Neuroscience Announce Joint Clinical Trial  for the use of an at-home tDCS device for treating depression

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Curebase Adds Pharma, Clinical Research Veteran to Advisory Board

Lars-Olof "Lollo" Erkisson, Head of Clinical Development at Infant Therapeutics AB, brings cross-continental clinical operations expertise to Curebase Advisory Board

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Curebase Secures $40M Series B

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Curebase Named Honorable Mention in Best World Changing Idea NA Category of Fast Company’s 2022 World Changing Ideas Awards

Curebase recognized by Fast Company's 2022 World Changing Ideas Awards for decentralized, patient-centric trial model

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Note to File Podcast - Episode 45: Jane Myles, Decentralized Clinical Trials: Evidence of Impact

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DCTs’ Broader and Multifaceted Implications

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Note to File Podcast - Episode 41: Jane Myles, VP Innovation at Curebase

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Forbes 30 Under 30 Names Curebase CEO Tom Lemberg to it's 2022 List

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Remote Care Powered CURE-19 Platform Enables At Home COVID-19 Clinical Trials

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Entire article

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Entire article

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An online mental health provider and a provider of decentralized clinical research teamed up to build an app that may offer a digital health solution to address provider shortages in mental healthcare.

Entire article

Expanding decentralized clinical trials demands flexibility

It's important to be creative when overcoming obstacles to access to wider improvements in trial design and participation, says Jane Myles, VP of clinical trial innovation at Curebase.

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Health app companies wrestle with how to design studies to prove treatments work

For companies that have spent years developing interactive technologies to help treat disease, the tricky question inevitably comes: How far are you willing to go to prove it works?

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Curebase partners with Meru Health for 3-year mental health trial

Curebase signed a three-year clinical trial with Meru Health

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Curebase and Meru Health to Partner on Clinical Research for App-based Mental Health Treatment Program

Curebase and Meru Health announce partnership on three-year clinical trial.

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Curebase Names Digital Infrastructure Veteran Matt Lanier as VP of Engineering

Curebase welcomes Matt Lanier as VP of Engineering

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Y Combinator Top Private Companies - 2022

Y Combinator released its list of top companies for 2022, this year Curebase was featured in the list of Top Private Companies.

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Curebase Names Medical Research Veteran Sean Lynch as VP of Clinical Operations

Curebase welcomes Sean Lynch as Vp of Clinical Operations

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Curebase Hires Healthcare Attorney Laura Podolsky to Head Legal Team

One of the first attorneys to specialize in DCTs, Laura Podolsky, joins Curebase as General Counsel.

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Curebase Hires Alan Sun as Vice President of Product

Alan Sun brings his passion for finding solutions that improve patient outcomes as Curebase's new VP of Product

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Curebase Releases enhanced Patient App add-on option to all studies to universally better patient participation and choice

User-friendly clinical trial solution design to increase participant engagement

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Curebase Hires HR Veteran Andi Seymour as VP of People

Andi Seymour brings over 15 years of progressive and hands-on experience to Curebase as the newly appointed VP of People.

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Curebase, Portamedic Partner to Support Decentralized Clinical Trials with Mobile Phlebotomy Services

Curebase and Portamedic partner to collect patient samples and other tests from participating DCT trial patients' homes throughout the U.S

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Curebase Hires Healthcare Technology Veteran Scott Garcia as Vice President of Finance

Scott Garcia brings 15+ years of experience scaling high-growth companies to Curebase as the new VP of Finance

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Curebase, Flow Neuroscience Announce Joint Clinical Trial  for the use of an at-home tDCS device for treating depression

Curebase and Flow Neuroscience investigate a digital therapeutic for reducing depressive symptoms.

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Curebase Adds Pharma, Clinical Research Veteran to Advisory Board

Lars-Olof "Lollo" Erkisson, Head of Clinical Development at Infant Therapeutics AB, brings cross-continental clinical operations expertise to Curebase Advisory Board

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Curebase Secures $40M Series B

Curebase closes $40M Series B led by Industry Ventures, with strategic investment by Gilead Sciences

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Curebase Named Honorable Mention in Best World Changing Idea NA Category of Fast Company’s 2022 World Changing Ideas Awards

Curebase recognized by Fast Company's 2022 World Changing Ideas Awards for decentralized, patient-centric trial model

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Note to File Podcast - Episode 45: Jane Myles, Decentralized Clinical Trials: Evidence of Impact

Part 2 of Note to File Podcast with Brad Hightower featuring Jane Myles, VP of Clinical Trial Innovation at Curebase

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Curebase Selected to Launch a Clinical Investigation of a Digital Therapeutic for IPF

Curebase and Vicore Pharma partner on IPF mental health digital therapeutic study

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DCTs’ Broader and Multifaceted Implications

Curebase featured as decentralized clinical provider optimizing digital processes for patient safety and scientific advancement

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Decentralized Clinical Trials Help Level the Playing Field for Health Equity

Jane Myles, VP of Innovation at Curebase, discusses how DCTs play a role in improving health equity

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Note to File Podcast - Episode 41: Jane Myles, VP Innovation at Curebase

Jane Myles appears on Note to File Podcast with Bradley Hightower to discuss all things DCT

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Curebase Rapidly Reaches Growth Milestone

Curebase hires its 100th teammate within six months of raising Series A financing

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Curebase and Blue Note Therapeutics Collaborate on Home-based Clinical Trial of Prescription Digital Therapeutics to Help People with Cancer Manage their Health

Curebase and Blue Note Therapeutics partner on a fully virtual study comparing effectiveness of two PDTs on mental and physical health of cancer patients recently/currently undergoing treatment

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Curebase and CoBTek (team from Côte d'Azur) to Collaborate on a European Clinical Trial of Remote Tools Designed to Help Seniors Retain Autonomy

Curebase launching DCT study in Italy and France with a lab from the University of Côte d'Azur to improve the quality of life for elderly people

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Curebase Adds Two Clinical Trial Veterans to Kick-off New Advisory Board

Curebase welcomes Dr. Amir Lahav, leading digital health innovator, and Dr. Aaron Kamauu, leading real-world data expert, to new Advisory Board

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Curebase Joins the SCRS Global Impact Partner Program

Curebase will work closely with Society for Clinical Research Sites to advance trial site engagement and sustainability

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The Growing Case for Digital Therapeutics

Continuous developments in digital health innovations has led to the expansions of the Digital therapeutics dtx clinical trial space

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Creating New Decentralized Clinical Trial Ecosystem Including Bring Your Own Physician Option with Tom Lemberg Curebase

Tom Lemberg, founder and CEO of Curebase, talks all things BYOP (Bring Your Own Physician) on Empowered Patient Podcast

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2022 Predictions for Health Equity

Healthcare IT Today features predictions from Tom Lemberg, founder and CEO of Curebase, on diversity in clinical research

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The Future of Clinical Trials is Here Today

Curebase founder and CEO, Tom Lemberg, discusses the future of patient-centric decentralized clinical trials, including the Bring Your Own Physician (BYOP) model

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Curebase and Persephone Biosciences Partner in Clinical Trial of Colorectal Cancer Among Diverse Populations

Curebase and Persephone, collaborating with Janssen Research & Development, announce study to develop prevention strategies and treatment options for colorectal cancer (CRC) focusing on patient diversity

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Built In Honors Curebase in Its Esteemed 2022 Best Places to Work Awards

Curebase Earns Top 100 on Built In's Best Remote-First Companies to Work for in 2022

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Curebase Joins WCG Avoca Quality Consortium

Decentralized clinical trial company brings expertise in remote studies to large industry group devoted to improving trial quality

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Curebase Technology Key to metaMe Health's FDA Clearance of Regulora

Curebase serves as technology and decentralized trial execution partner for MetaMe Health's digital therapeutic dtx

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Curebase Named to the 2021 CB Insights Digital Health 150 -- List of Most Innovative Digital Health Startups

Curebase recognized for achievements in Clinical Trials Tech

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Curebase CEO, Tom Lemberg, Featured in Drug Discovery and Development's "9 Predictions for Pharma in 2022"

Curebase CEO offers expert insight into the dawn of dynamic clinical trial designs

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Forbes 30 Under 30 Names Curebase CEO Tom Lemberg to it's 2022 List

Founder and CEO of Curebase receives Forbes 30 Under 30 prestigious honor for leading positive, global change in healthcare

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Curebase's Enhanced Telemedicine Feature Expands Patient Access to Edesa Biotech Derm Study

Edesa Biotech uses Curebase's eClinical platform for enhanced telemedicine that allows providers to view, measure, and record patient symptoms via the built-in application

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Curebase, LEVEL Announce Clinical Trial to Determine Whether Cannabinoids Can Help Veterans Sleep Better

Decentralized clinical trials leverages Curebase eclinical software platform, Veterans' advocacy groups

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Curebase, Checkable Medical Announce Joint Clinical Trial to Assess Effectiveness of At-home Strep Test Kit

Curebase and Checkable Medical launch first-ever at-home strep test decentralized clinical trial

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Curebase, Digital Therapeutics Alliance Announce Partnership to Accelerate Adoption of DTx Products

Curebase and DTA partner to develop a joint white paper to provide clinical trial regulatory guidance and best practices for DTx clinical evidence generation

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Curebase Solutions Supports Another InBios FDA Emergency Use Authorization for COVID-19 IgG Antibody Rapid Test

Curebase's decentralized clinical trial approach helps secure FDA Emergency Use Authorization for InBios' new COVID-19 IgG Antibody Rapid Test

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Curebase Hires Katri Langel as Senior Director of Program Development for Europe

Katri Langel, international IT and clinical research expert, joins Curebase as Senior Director of Program Development for Europe

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Curebase Hires Wayne Bowden as Vice President of Business Development

Curebase names clinical trials veteran, Wayne Bowden, as Vice President of Business Development to lead new growth and expansion efforts

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It's a virtual world: Curebase, AppliedVR team up on virtual reality-based, at-home clinical trials

AppliedVR will test its virtual-reality-based digital therapeutics dtx across five studies using the decentralized clinical trials software from Curebase

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Curebase Secures Jane Myles as Vice President of Clinical Trial Innovation

Curebase has named tenured clinical research expert Jane Myles as vice president of clinical trial innovation

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Curebase, Adaptive Biotechnologies Announce Collaboration to Expand Clinical Study Access

Curebase decentralized clinical trial model will be used to study effectiveness in infections disease study

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Introducing ‘BYOP’ Clinical Trials

Curebase is promoting the concept of 'bring-your-own-physician' clinical trials.

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Curebase Names Paul Donnelly as Senior Vice President of Enterprise Strategy

Industry veteran, Paul Donnelly, brings more than two decades of success building healthcare companies to Curebase

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Startups Cash In as Venture Funding for Digital Health Rises

Curebase featured in Wall Street Journal among startups realizing venture capital boom in digital health

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Curebase, InBios Announce Results of Virtual Clinical Trial of InBios COVID-19 Rapid Detection Test Using Curebase Platform

Curebase decentralized trials platform used to study efficacy of diagnostic test

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Curebase Nabs $15M for Siteless Trials that Revolve 'Around the Patient's Lifestyle'

Curebase has raised a $15 million series A for a new approach to decentralized trials that goes beyond the current drop of virtual trial platforms.

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Cofactor Genomics Begins Multi-Site Clinical Trial for Immunotherapy Prediction Assay

Curebase is participating as a CRO partner with Cofactor Genomics in first multicenter clinical trial of its OncoPrism immunotherapy response prediction assay

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Non-Traditional Clinical Trial Sites Powered by the Curebase System Support Emergency Use Authorization of New Rapid COVID-19 Test

Operationalizing drive-through COVID testing locations as clinical research sites provided a safe and convenient way to enroll and consent potential participants in key diagnostic validation study

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CLM Tests Drug Plus Digital Combo for High Blood Pressure

CLM drug and DTx digital therapeutics study with Curebase

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Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial

Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness.

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Remote Care Powered CURE-19 Platform Enables At Home COVID-19 Clinical Trials

Curebase launches the CURE-19 Platform to provide a resource for researchers seeking to better understand COVID-19 as the pandemic begins

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