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Whitney Stewart, Director of Clinical Project Management, Shares Insights from Publication with DTA

Smriti Bhardwaj

Shots:

  • Whitney gave a brief on the partnership of Curebase with Digital Therapeutics Alliance to provide fit-for-purpose evidence standard for DTx product regulatory, reimbursement, and clinical acceptance
  • Whitney also elaborated on the Fit-for-Purpose Evidentiary standards and talked about why  the DTx devices do not fit in the standards for medical devices by quoting some examples
  • The interview highlights Curebase’s mission to bring quality medical innovations to patients faster to improve human well-being through more efficient clinical studies

Smriti: Thanks for taking the time to talk to us. Firstly, I would like to start with understanding the deal details between Digital Therapeutics Alliance (DTA) and Curebase (financial and commercial details).

Whitney Stewart: Curebase and DTA have a partnership centered around digital therapeutics (DTx) innovation and thought leadership with a shared goal to help DTx organizations conduct effective clinical trials. The partnership is focused on education rather than commercial activities.  

For example, in December, the DTA and Curebase released a publication titled, “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard,” which provides evidence-based expectations for how DTx products should be validated by stakeholders globally. The paper outlines foundational principles specific to DTx and baseline expectations for healthcare decision-makers concerning the types, quality, and timing of clinical trials necessary to evaluate and implement DTx therapies in real-world settings.  

Our partnership is part of DTA’s Resource Partner Program, which the organization launched to accelerate the development and post-marketing success of clinically evaluated DTx by building a network of commercialization and product development service providers.  

Smriti: Can you please elaborate in detail for our readers what is Fit-for-Purpose Evidentiary standards with some examples?

Whitney Stewart: Fit for purpose in this setting suggests an actual system or framework specific to a product type used for evaluation. That doesn’t currently exist for digital therapeutics, but there are existing, well-defined standards for pharmaceuticals and medical devices.  In the U.S., the Code of Federal Regulations outlines the requirements for both product types. For example, if you develop a medicine that can treat diabetes and you desire FDA approval, the path is standardized and clearly laid out. You will perform a number of clinical trials of various phases, and the evidence will (hopefully) demonstrate your product is both safe and effective. In this case, the FDA has the framework to evaluate that evidence and confidently provide an outcome. Similarly, insurance companies generally cover approved drugs based on efficacy.

A similar framework exists for medical devices. As part of the process of seeking approval to market, you can either claim it is equivalent to a product already approved or provide safety and efficacy data in hopes of getting approval.  

Digital therapeutics are neither pharmaceuticals nor medical devices, so the goal is to create standards for that product type instead of trying to interpret and overlay the framework of different product types.

Smriti: How do Curebase and DTA complement each other in setting standards for DTx?

Whitney Stewart: Curebase is very familiar with the clinical evidence-generation space. We've seen what some digital therapeutics companies have done in terms of designing their protocols and their overall strategies for evidence generation. We've also worked in other product areas: diagnostics, medical devices, pharmaceuticals, etc. Curebase’s experience is in clinical trials and understanding the process of getting drugs or devices approved. For this paper, our contribution focused on the clinical evidence quality section and some of the clinical trial design components.

The DTA and its network of members have vast experience in going through the process of getting approval and communicating directly with regulatory bodies and with payers.  The standards created were designed through collaboration with many members of the DTA community.

Smriti: Can you please tell our readers why you think standards for medical devices don’t fit the DTx devices?

Whitney Stewart: When you think of a medical device – a pacemaker, a heart-rate monitor, or pregnancy test may come to mind. To get clearance or approval from the FDA, manufacturers must assess the risk of the device. This means they must either provide evidence it is similar to an already approved device – thus requiring no clinical testing – or perform clinical studies that demonstrate its safety and effectiveness. Devices typically are based on hardware and software, and the components don’t typically change much.  

Now, think of some examples of digital therapeutics: a video game to treat children with ADHD, a mobile application to help with insomnia, or a virtual reality program to help with chronic lower back pain. They have a therapeutic intent and generally a lower risk profile. How do you prove those “devices” are safe and effective? In many ways, the process for generating evidence of a DTx is actually more similar to a pharmaceutical than to a medical device. For example, you aren’t proving the video game software can be used to accurately diagnose ADHD. That’s not the claim. Instead, you are trying to prove that using the software helps treat ADHD, similar to the way a drug may. The standards for medical devices just don’t apply to digital therapeutics.

Smriti: Can you please summarize “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard” for our readers?

Whitney Stewart: The guidance offered in the Curebase/DTA joint publication starts by providing sufficient background information on the types of outcomes and endpoints, types of trials, and other general information required to understand the landscape and types of evidence that may be generated for a DTx. This is an important component.

We then go into defining what level of quality should be expected and generated under each clinical outcome domain for the primary stakeholders. Finally, it outlines the phases of development, what types of studies you’ll see at those junctures, and what type of evidence typically is generated in each stage.  

Our overall goal with the publication was to provide a foundational understanding of evidence pathways so healthcare decision-makers (regulatory bodies, payers, clinicians, etc.) can appropriately interpret and assess the data DTx companies are submitting and the claims they're making.  

Smriti: How does this fit-for-purpose standard guidance help payors, providers, and policymakers?

Whitney Stewart: The guidance is intended for healthcare decision-makers to provide a framework in which they can assess the clinical evidence and feel confident in their ability to determine if it is safe and effective and whether it should be approved, reimbursed, or prescribed. It is challenging to understand when the evidence is sufficient if you are comparing it to the already existing frameworks of pharmaceuticals, medical devices, or even software as medical devices.

Smriti: Is this collaboration working to make DTx assessment standards global or for now U.S. only?

Whitney Stewart: Our joint white paper with DTA was intentionally made regional-agnostic and is intended to apply across the globe. There are some specific references to FDA guidelines where appropriate to provide additional context or helpful information.

Original Article

Whitney Stewart, Director of Clinical Project Management, Shares Insights from Publication with DTA

Shots:

  • Whitney gave a brief on the partnership of Curebase with Digital Therapeutics Alliance to provide fit-for-purpose evidence standard for DTx product regulatory, reimbursement, and clinical acceptance
  • Whitney also elaborated on the Fit-for-Purpose Evidentiary standards and talked about why  the DTx devices do not fit in the standards for medical devices by quoting some examples
  • The interview highlights Curebase’s mission to bring quality medical innovations to patients faster to improve human well-being through more efficient clinical studies

Smriti: Thanks for taking the time to talk to us. Firstly, I would like to start with understanding the deal details between Digital Therapeutics Alliance (DTA) and Curebase (financial and commercial details).

Whitney Stewart: Curebase and DTA have a partnership centered around digital therapeutics (DTx) innovation and thought leadership with a shared goal to help DTx organizations conduct effective clinical trials. The partnership is focused on education rather than commercial activities.  

For example, in December, the DTA and Curebase released a publication titled, “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard,” which provides evidence-based expectations for how DTx products should be validated by stakeholders globally. The paper outlines foundational principles specific to DTx and baseline expectations for healthcare decision-makers concerning the types, quality, and timing of clinical trials necessary to evaluate and implement DTx therapies in real-world settings.  

Our partnership is part of DTA’s Resource Partner Program, which the organization launched to accelerate the development and post-marketing success of clinically evaluated DTx by building a network of commercialization and product development service providers.  

Smriti: Can you please elaborate in detail for our readers what is Fit-for-Purpose Evidentiary standards with some examples?

Whitney Stewart: Fit for purpose in this setting suggests an actual system or framework specific to a product type used for evaluation. That doesn’t currently exist for digital therapeutics, but there are existing, well-defined standards for pharmaceuticals and medical devices.  In the U.S., the Code of Federal Regulations outlines the requirements for both product types. For example, if you develop a medicine that can treat diabetes and you desire FDA approval, the path is standardized and clearly laid out. You will perform a number of clinical trials of various phases, and the evidence will (hopefully) demonstrate your product is both safe and effective. In this case, the FDA has the framework to evaluate that evidence and confidently provide an outcome. Similarly, insurance companies generally cover approved drugs based on efficacy.

A similar framework exists for medical devices. As part of the process of seeking approval to market, you can either claim it is equivalent to a product already approved or provide safety and efficacy data in hopes of getting approval.  

Digital therapeutics are neither pharmaceuticals nor medical devices, so the goal is to create standards for that product type instead of trying to interpret and overlay the framework of different product types.

Smriti: How do Curebase and DTA complement each other in setting standards for DTx?

Whitney Stewart: Curebase is very familiar with the clinical evidence-generation space. We've seen what some digital therapeutics companies have done in terms of designing their protocols and their overall strategies for evidence generation. We've also worked in other product areas: diagnostics, medical devices, pharmaceuticals, etc. Curebase’s experience is in clinical trials and understanding the process of getting drugs or devices approved. For this paper, our contribution focused on the clinical evidence quality section and some of the clinical trial design components.

The DTA and its network of members have vast experience in going through the process of getting approval and communicating directly with regulatory bodies and with payers.  The standards created were designed through collaboration with many members of the DTA community.

Smriti: Can you please tell our readers why you think standards for medical devices don’t fit the DTx devices?

Whitney Stewart: When you think of a medical device – a pacemaker, a heart-rate monitor, or pregnancy test may come to mind. To get clearance or approval from the FDA, manufacturers must assess the risk of the device. This means they must either provide evidence it is similar to an already approved device – thus requiring no clinical testing – or perform clinical studies that demonstrate its safety and effectiveness. Devices typically are based on hardware and software, and the components don’t typically change much.  

Now, think of some examples of digital therapeutics: a video game to treat children with ADHD, a mobile application to help with insomnia, or a virtual reality program to help with chronic lower back pain. They have a therapeutic intent and generally a lower risk profile. How do you prove those “devices” are safe and effective? In many ways, the process for generating evidence of a DTx is actually more similar to a pharmaceutical than to a medical device. For example, you aren’t proving the video game software can be used to accurately diagnose ADHD. That’s not the claim. Instead, you are trying to prove that using the software helps treat ADHD, similar to the way a drug may. The standards for medical devices just don’t apply to digital therapeutics.

Smriti: Can you please summarize “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard” for our readers?

Whitney Stewart: The guidance offered in the Curebase/DTA joint publication starts by providing sufficient background information on the types of outcomes and endpoints, types of trials, and other general information required to understand the landscape and types of evidence that may be generated for a DTx. This is an important component.

We then go into defining what level of quality should be expected and generated under each clinical outcome domain for the primary stakeholders. Finally, it outlines the phases of development, what types of studies you’ll see at those junctures, and what type of evidence typically is generated in each stage.  

Our overall goal with the publication was to provide a foundational understanding of evidence pathways so healthcare decision-makers (regulatory bodies, payers, clinicians, etc.) can appropriately interpret and assess the data DTx companies are submitting and the claims they're making.  

Smriti: How does this fit-for-purpose standard guidance help payors, providers, and policymakers?

Whitney Stewart: The guidance is intended for healthcare decision-makers to provide a framework in which they can assess the clinical evidence and feel confident in their ability to determine if it is safe and effective and whether it should be approved, reimbursed, or prescribed. It is challenging to understand when the evidence is sufficient if you are comparing it to the already existing frameworks of pharmaceuticals, medical devices, or even software as medical devices.

Smriti: Is this collaboration working to make DTx assessment standards global or for now U.S. only?

Whitney Stewart: Our joint white paper with DTA was intentionally made regional-agnostic and is intended to apply across the globe. There are some specific references to FDA guidelines where appropriate to provide additional context or helpful information.

Original Article

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Note to File Podcast: Whitney Stewart, Curebase

In this episode we discuss evidence standards for digital therapeutics and the recent Digital Therapeutics Alliance publication “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard”.

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The Regulatory Landscape of DTx, with Whitney Stewart

Welcome to DTx Equals, the show where thought leaders in digital therapeutics put a stake in the ground about what makes DTx, DTx.

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DTx and the case for fit-for-purpose evidentiary standard

Learn about the joint whitepaper put forth by the DTA and Curebase on evidentiary standards in DTx and what future implications for the industry are.

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Curebase Selected Among Y Combinator's Top Private Companies of 2023

DCT platform company places in top 6% of private companies; recognized for end-to-end clinical trial execution built on cutting-edge software

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Advancing the Future of Clinical Trials with Jane Myles

Passionate Pioneers with Mike Biselli

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What Does 2023 Hold For Biopharma? Part 7: Clinical Trial Trends

Whitney Stewart shared her predictions for 2023

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Curebase in the top 6% of Y Combinator's Private Companies

Curebase appeared in Y Combinator's 2023 list of top private companies where we are noted for our end-to-end clinical trial execution built on cutting-edge software.

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Whitney Stewart, Director of Clinical Project Management, Shares Insights from Publication with DTA

PharmaShots interviews Whitney Stewart

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Q&A WITH CUREBASE’S JANE MYLES

Med Ad News talked to Jane Myles, vice president of clinical trial innovation at Curebase, about improving clinical trials and patient experience.

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The Virtual Shift: Whitney Stewart and Megan Coder on Digital Therapeutics

Host Tom Foley invites Whitney Stewart, Director of Clinical Project Management at Curebase & Megan Coder, Founder, Chief Policy Officer at DTxAlliance.

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Curebase Launches All-in-One Software and Trial Execution Package to Help Digital Therapeutics Companies Accelerate Clinical Trials

Curebase is a one-stop shop for running your digital therapeutics trial from start to finish

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Pharma Mirror Q&A with Jane Myles, Vice President of Clinical Trial Innovation at Curebase

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Curebase Celebrates Year of Growth, Organizational Maturity

DCT platform company expands business, adds executive talent

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Curebase Releases Diagnostic Offering that Delivers First All-Inclusive Package of Software and Services Needed to Fully Execute Diagnostic Studies

Start-up trials achieved in eight to 12 weeks, a fraction of typical timeframe

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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)

Publication provides a foundational set of expectations outlining the necessary clinical evidence to enable appropriate and efficient assessment reflective of the unique nature and innovation cycles of DTx products

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Curebase Partners with Redenlab to Expand Data Capture Capabilities in Pharma Trials

Curebase partners with Redenlab to deliver high-quality patient data

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Smarter Clinical Trials with Jane Myles

A new approach allows patients to participate in clinical trials from home and with community physicians

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The Key To Innovation In Clinical Research? Listening.

Jane Myles, Vice President, Clinical Trial Innovation at Curebase, discusses her current role, what led her there, and challenges their clients face with DCTs.

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Curebase and BEKHealth Join Forces to Expand Access to Decentralized Clinical Trials

Curebase to Leverage BEKHealth's Integrated Clinical Research Platform to More Easily Find and recruit Decentralized Trial Participants, Expand into Oncology and New Therapeutic Areas

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The digital therapeutics revolution is happening and Big Pharma is buying in — with caution

Companies like Pfizer, Novartis, Sanofi and BMS are diving into the world of digital therapeutics while recognizing the limitations of the young field.

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How Digital Health Solutions Can Address Shortages in Mental Healthcare

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.

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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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