In the News

Curavit Clinical Research: team appoints

Oct 7, 2021

Decentralized Trials & Research Alliance Grows, Partnerships in Site Conduct, Trial Diversity, More

Oct 7, 2021

Curavit Clinical Research, a virtual contract research organization (VCRO) that designs and executes decentralized clinical trials (DCTs), announced today that it has joined the Decentralized Trials & Research Alliance (DTRA) to further the advancement and adoption of decentralized clinicals. Curavit Clinical Research has also announced the appointments of Jay Collier, as chief operating officer (COO), and Candice Del Rio, as director of clinical operations. The company also expanded its sales team with the hiring of Chris O’Shaughnessy, as vice president of business development, as well as Troy Hall and Bill Dreyer, as directors of business development. The expansion comes as DCTs continue their steady growth, punctuated by Curavit’s doubling its revenue since 2020.

Beech Tree Labs Selects Curavit Clinical Research to Push Toward 100% Virtual Clinical Trials

Sept 20, 2021

Beech Tree Labs has developed a novel drug development platform known as resonant molecular signaling (RMS), that aims to address a wide range of illnesses by restoring normal cellular communications and correcting various imbalances triggering problems. The company opted to go virtual for their next Phase 2, FDA-authorized clinical trial to evaluate the effect of Beech Tree’s BT-TML therapy targeting COVID-19 patients. Although many companies have moved to at least some provisional virtual or hybrid approach during the pandemic, Beech Tree Labs took another step toward a permanent move to virtual trials by partnering with Curavit Clinical Research for a fully decentralized trial. The Park City, Utah-based venture has an ambitious plan to disrupt the operation of clinical trials, accelerating timelines and reducing cost while maintaining if not improving quality with improved, patient-centric care.

Move to Decentralized or Virtual Trials more than ‘Flipping a Switch’

Recently, TrialSite writer Joseph Constance assessed the emerging virtual clinical trials landscape particularly in the midst of the COVID-19 pandemic. In an earlier piece, Constance suggested the move to decent…

Chapel Hill startup targets seed funding after working to diversify Novavax Covid-19 vaccine trial

May 16, 2020
Chapel Hill startup targets seed funding after working to diversify Novavax Covid-19 vaccine trial

A Chapel Hill startup that helped bring diversity to Novavax’s (Nasdaq: NVAX) clinical trials for its Covid-19 vaccine is in the process of raising $250,000 in funding to help it continue to grow.

CliniSpan Health is actively raising seed funding to grow its team of eight to 20 by 2022, said Dezbee McDaniel, the company’s co-founder and head of business development who earned his undergraduate degree from UNC-Chapel Hill.

“We are looking to grow rapidly,” McDaniel said.

The company was started with the goal to bring more diversity to clinical trials, and in January the Novavax trial was the first CliniSpan began recruiting for, McDaniel said. About 17 percent of the Black participants at the Durham clinical trial site and 20 percent at the Chapel Hill site were referred to Novavax by CliniSpan, McDaniel said.

The lack of diversity in clinical trials has been an ongoing problem for years.

In 2020, the U.S. Food and Drug Administration approved 53 novel drugs that had clinical trials with a total of 32,000 patients. Of those patients, 75 percent were white, 8 percent were Black, 6 percent were Asian and 11 percent were Hispanic.

“We are heavily focused on African Americans right now,” McDaniel said. “We want to expand to groups who are Latinx, Native American, rural, women – a lot of other diverse groups who also need access to clinical trials.”

For now, the company is focusing on one population at a time, McDaniel said, because each group has a different history with the medical system and different preferences for how they want to be communicated with.

“With African Americans, the past mistreatment by the health care system is what we have to overcome and that’s something we haven’t directly affected, so it’s difficult to have that conversation sometimes,” McDaniel said.

Having people who reflect those groups do the outreach and recruitment helps make people more comfortable in participating, he said.

The transition to more decentralized trials also helps, McDaniel said.

“If people don’t have to show up physically and they can do it from home, then access for us becomes that much easier of a goal to achieve,” he said.

In addition to the Novavax trial, CliniSpan has partnered with Curavit, a fully virtual clinical trial organization, which perfectly complements CliniSpan’s infrastructure, McDaniel said.

CliniSpan has also signed a licensing agreement for its software with Capstone Health Alliance, a group purchasing organization for hospitals, he said.

“That’s something we’re trying to grow outside of our recruitment services,” McDaniel said. “We’re trying to help other diversity recruitment arms have technological infrastructure to carry out their processes more effectively.”

At the same time, CliniSpan will be helping to recruit for studies that its hospital network participates in, McDaniel said.

CliniSpan, which is led by founder and CEO Dr. David Lipsitz who did his residency at UNC-Chapel Hill, is currently working with five businesses in total and is generating revenue, though McDaniel did not disclose how much.

17 Virtual Clinical Trial Providers to Partner up With

Apr 7, 2020
17 Virtual Clinical Trial Providers to Partner up With

Virtual clinical trial providers are your must-partners for any decentralized trial or contingency plan. In March 2020 the FDA encouraged sponsors to assess alternative methods for keeping their trials on track within the existing limitations under Covid-19 quarantine. Remote/virtual trials are no longer just a convenient way to shorten timelines and reduce costs but a rescue solution to ongoing clinical trials. From recruiting participants to designing their virtual experience, remote trial providers and technology can save your data and your budget.

Curavit launches with aim to be 'next-generation' trial specialist

Feb 18, 2020

Getting the right patients into the right trial at the right time, and keeping them there, is a tough gig.

It’s a problem biopharma companies and their outsourcing partners have struggled with for years. One of the latest proposed solutions to this has been twofold: better tech and allowing patients to be trial participants in the comfort of their homes, both of which are thought to help retention and recruitment.

Curavit is the latest startup, launched officially this week, to offer this service via its telehealth and clinical trial tech platforms. It aims to “engage directly with patients in their homes,” according to its release.

How does it work? The company explains: “Our decentralized trial model means Curavit is not tied to any specific geography. We focus on patient populations across geographies and enroll patients that historically have not had access to clinical trials.

“To recruit this patient population, we partner with medical group practices and other health-related entities that historically have not participated in clinical research. Curavit enables these entities to take advantage of the benefits clinical trials provide without having to manage the actual trials. Together we recruit their patients for trials.

“Once patients are enrolled, we engage with the trial subjects via our tele-health solution. This enables the patients to participate from the comfort of their homes.”

It’s run by CEO Joel Morse, former chief and founder at C3i, a pharma services-focused company, and machine learning and data analytics specialist Todd Morse, Curavit’s chief technology officer and co-founder, who formerly worked on products for the Chan Zuckerberg Initiative.

More details are scant at present, but the company said it plans to open its first site in Boston “this summer.”

Curavit Clinical Research, has been launched to help realise the potential of decentralised clinical trials

Feb 20, 2020
A new clinical trials company, Curavit Clinical Research, has been launched to help realise the potential of decentralised clinical trials.

A new clinical trials company, Curavit Clinical Research, has been launched to help realise the potential of decentralised clinical trials.

Launched by industry veterans Joel Morse and Dave Hanaman, the new entity will focus on virtual trials.

Curavit Clinical Research co-founder and CEO Joel Morse said: “Curavit is the result of our desire to solve growing challenges to the important work of drug discovery.

“By combining experience, technology, and solid execution, we will bring cutting-edge research to previously untapped and underserved patient populations.”

Curavit Clinical Research is a next-generation clinical trial enterprise that provides decentralised clinical trial execution. It takes a clean-sheet approach to clinical trials, from the design phase to execution.

Optimised on a new virtual model, the company supports patients’ participation from wherever they live.

Curavit Clinical Research chief commercial officer and co-founder Dave Hanaman added: “We are fortunate to have worked with some of the most respected companies and visionary people in the life sciences industry, and are honored by the support we are receiving from them for this effort.”

Global clinical trials market stands at $70bn and continues to grow, while the success rate of trials continues to see a decline. This is often due to lack of enrollment by patients and participation from doctors.

Press Releases

Curavit Expands Leadership and Sales Teams to Drive Continued Growth of Decentralized Clinical Trials Across Life Sciences Industry

Sept 29, 2021
Curavit Expands Leadership and Sales Teams to Drive Continued Growth of Decentralized Clinical Trials Across Life Sciences Industry

BOSTON— Sept.29, 2021 — Curavit Clinical Research, a virtual contract research organization (VCRO) that designs and executes decentralized clinical trials (DCTs), announced today the appointments of Jay Collier, as chief operating officer (COO), and Candice Del Rio, as director of clinical operations. The company also expanded its sales team with the hiring of industry veterans, Chris O’Shaughnessy, as vice president of business development, as well as Troy Hall and Bill Dreyer, as directors of business development. The expansion comes as DCTs continue their steady growth, punctuated by Curavit’s doubling its revenue since 2020.

Curavit continues to disrupt clinical research by enabling digitally native DCTs that expand trial access to previously underserved patients while improving patient participation, data quality, and research speed.

Jay Collier brings more than 20 years of operational experience serving global clients in life sciences and clinical research. In his role as COO, he will manage all aspects of service delivery for Curavit’s clients.  Prior to joining Curavit, Collier served in various leadership positions, most recently senior vice president of U.S. operations at C3i Solutions, a global leader in healthcare technology services. C3i was also founded by Curavit’s co-founders, Joel Morse and Dave Hannaman, who sold the company to a Fortune Global 500 company in 2018. Before C3i, Collier served in various director-level roles at Nextel.

“Having worked with Joel and Dave for nearly 20 years at their previous company, I’m excited to join Curavit to help build another successful venture that will streamline the clinical trial process with advanced technology, and essentially improve global health and save lives,” said Collier. “This is a huge opportunity to make a meaningful difference in clinical research for years to come.”

Candice Del Rio, Curavit’s new director of clinical operations, has more than 12 years of clinical research experience in academic , clinical, and industry settings. Prior to joining Curavit, she worked at Massachusetts General Hospital as a clinical research nurse and an oncology/hematology nurse for over a decade. She will bring her in-depth experience in the areas of clinical trial development, patient recruitment and retention, and process improvement to manage projects and ensure customer success.

In addition, Curavit welcomes Chris O’Shaughnessy, as vice president of business development, who also comes from C3i Solutions; Bill Dreyer, as director of business development, previously manager of business development for EPL Archives, Inc.; and Troy Hall, as director of business development, who last served as a cardiovascular institutional specialist at Johnson & Johnson.

“It’s an exciting time at Curavit as we grow along with the rapid evolution and adoption of decentralized clinical research,” said Joel Morse, co-founder and CEO of Curavit. “We are taking it to the next level and our new team members will bring their collective expertise to help drive innovation and customer satisfaction, while delivering our scalable and purpose built clinical trial platform to our clients.”

In other news today, Curavit announces its membership into the Decentralized Trials and Research Alliance (DTRA). The DTRA includes 100 organizational members who represent the diverse ecosystem needed for the adoption of decentralized research methods, including sponsors, regulatory authorities, patient advocacy groups, contract resource organizations, technology companies, investigator sites, and other key stakeholders.

About Curavit

Curavit Clinical Research is a virtual contract research organization (VCRO) that designs and executes Decentralized Clinical Trials (DCTs). Founded by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, minimizing the need for physical infrastructure and travel while increasing data quality. Curavit brings together the world’s leading researchers, enrolls previously untapped and underserved patient populations, and applies machine learning to health and social engagement information to recruit participants. Current clients include Frequency Therapeutics, Beech Tree Laboratories, Brown University, and Boston Medical Center. For more information, visit www.curavitclinicalresearch.com.

Media Contacts:

Jamie Dabao Brown, +1 (626) 488-0732, jamie@barbadoraink.com

Lisa Barbadora, +1 (610) 420-3413, lbarbadora@barbadoraink.com

First All-Virtual CRO, Curavit, Joins the Decentralized Trials & Research Alliance

Sept 29, 2021
First All-Virtual CRO, Curavit, Joins the Decentralized Trials & Research Alliance

BOSTON— Sept. 29, 2021 — Curavit Clinical Research, a virtual contract research organization (VCRO) that designs and executes decentralized clinical trials (DCTs), announced today that it has joined the Decentralized Trial & Research Alliance (DTRA) to further the advancement and adoption of decentralized clinicals.

Established in 2020, the DTRA enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. It works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods.

“We are extremely gratified to welcome Curavit to the ‘Decentralized Trials & Research Alliance,’ said Amir Kalali, MD, founder of several collaborative life science communities, and co-Chair of DTRA. “By advancing decentralized research we can make the clinical trial process more patient-focused, increase trial efficiency and encourage use of technologies. We are excited by Curavit’s commitment to embracing decentralized trials and to changing the culture that has been the rate limiter to innovation.”

“This is an important opportunity for Curavit to collaborate with other DCT pioneers to further our mutual mission of making patient participation more accessible across all demographics,” said Joel Morse, co-founder and CEO of Curavit. “We look forward to sharing best practices, research methodologies, and technologies that will transform how research gets done.”

In other news today, Curavit announced the expansion of its leadership and sales teams (link to release on website) and the doubling of its revenue, indicative of the continued industry wide growth of DCTs.

About Curavit

Curavit Clinical Research is a virtual contract research organization (VCRO) that designs and executes Decentralized Clinical Trials (DCTs). Founded by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, minimizing the need for physical infrastructure and travel while increasing data quality. Curavit brings together the world’s leading researchers, enrolls previously untapped and underserved patient populations, and applies machine learning to health and social engagement information to recruit participants. Current clients include Frequency Therapeutics, Beech Tree Laboratories, Brown University, and Boston Medical Center. For more information, visit www.curavitclinicalresearch.com.

Media Contacts:

Jamie Dabao Brown, +1 (626) 488-0732, jamie@barbadoraink.com

Lisa Barbadora, +1 (610) 420-3413, lbarbadora@barbadoraink.com

Beech Tree Labs selects Curavit Clinical Research for fully virtual COVID-19 clinical trial

Sept 18, 2020
Curavit Clinical Research - Press Article
Curavit chosen for expertise in decentralized trial design and execution.

Beechtree Labs has chosen Curavit Clinical Research for a fully decentralized clinical trial to investigate a promising Covid-19 therapy. The FDA-authorized phase 2 clinical study will evaluate the effect of Beech Tree’s BTL-TML therapy on mean duration and severity of disease in 40 outpatients aged 60 years or older with underlying conditions. The study also assesses the safety of BTL-TML over 10 days of treatment and an additional four days of follow-up.

The trial is unique in that it is a fully decentralized clinical trial, made possible by applying virtual trial design protocols, digital telehealth technologies, electronic patient reported outcomes (ePRO), and full web and contact center patient support to eliminate the need for in-person office visits.

Thomas Hatch, Director of Business Development at Beech Tree said: “We chose Curavit because of their exclusive focus on designing and executing virtual trials. We needed a company with Curavit’s expertise in this important new discipline of clinical research in order to make this trial possible.” Joel Morse, CEO of Curavit added: “This is a unique opportunity to apply modern trial design and telehealth
technologies to allow patients to participate in this study without the potential risk of traveling to physical sites and to participate from the safety and comfort of their own homes.”

ABOUT CURAVIT

Curavit is a new type of clinical research company that designs and executes decentralized – also called “virtual” – clinical trials. Curavit brings together the world’s leading researchers, enrolls previously untapped and underserved patient populations, applies machine learning algorithms to health and social
engagement information, and leverages leading telehealth, patient data platform, and medical device technologies. Connect: https://www.linkedin.com/company/curavit/
Follow: https://twitter.com/CuravitClinical

ABOUT BEECHTREE LABS

Located in Providence, RI, Beech Tree Labs, Inc. (BTL) focuses on the discovery and early development of therapeutic agents that address a spectrum of unmet medical needs. The company has an extensive portfolio of patented formulations for products intended to treat such disorders as urinary incontinence, allergies, benign prostatic hypertrophy, anxiety, chronic obstructive pulmonary disease and herpesvirus infections. BTL has conducted over 15 FDA- authorized phase 2 trials and has out-licensed both technology and products.

LEARN MORE ABOUT THIS STUDY

The current FDA-approved Phase II pilot study is taking place in Draper, Utah at Intermountain Clinical Research. Additional sites will open in the future. To learn more about this study:

● You or your doctor may contact the study research staff ( deann@icrtrials.com ) or call
833-358-3784.
● Visit the study website: https://www.sickwithcoronavirus.com/
● You can also visit clinicaltrials.gov, the U.S. National Library of Medicine database of clinical studies conducted around the world. ClinicalTrials.gov identifier (NCT number): NCT04522830

MEDIA CONTACT

Dave Hanaman, Chief Commercial Officer, Curavit
info@curavitclinicalresearch.com

Curavit Clinical Research and eMoyo USA, LLC Partner to Deliver High-Quality Home-Based Audiometric Data for Virtual Clinical Trials

Sept 9, 2020
Curavit Clinical Research - Press Article

New solution allows patients to participate in clinical trials from the comfort and safety of their own homes.

Curavit Clinical Research, a virtual research organization, and eMoyo USA, LLC, the USA representative of eMoyo, a global leader in healthcare technology, today
announced a partnership to pave the way for hearing research studies to continue
during the COVID-19 pandemic. Curavit’s virtual team of audiologists remotely monitor the hearing of research subjects in their homes using the eMoyo KUDUwave™ Pro boothless audiometer. This portable, high-frequency audiometer enables a booth-free operation and extended high frequency hearing test up to 16 kHz, making the KUDUwave™ Pro the ideal solution for virtual or hybrid clinical trials which require audiology end points.

“With KUDUwave™ boothless diagnostic audiometers we can now test patients in their homes without compromising on the quality of testing and without having to transport and maintain an audiometric booth. Given COVID-19, this provides a lower health risk for the study subjects, as the soundbooth could be a source of cross contamination.” says Grant Talbot, of eMoyo.

Prior to every planned audiology test date, a Curavit Study Team member sends a
pre-configured laptop and a KUDUwave headset to each study subject’s home. Working directly with the study subject, a Curavit audiologist initiates a telemedicine visit where they perform a thorough, high quality audiometric evaluation. The final data is securely transferred to the Curavit Study Team, where it is stored in a secure and validated system.

“With this unique technology, teamwork, and our proprietary protocols, a clinical trial subject performs a comprehensive hearing test in less than an hour, all from the comfort of their home,” said Dr. Pam Diamond, Otolaryngologist, co-founder and Chief Medical Officer of Curavit. “KUDUwave combines the audiometer, headset and required components into a single, portable, lightweight device weighing only half a pound and it is controlled remotely by our audiologists using a laptop and telemedicine software. This process may shorten the trial timeline, and minimizes the potential for trial disruption due to COVID-19.”

“We are honored to partner with eMoyo and to work together to bring these
best-in-class offerings to virtual and hybrid clinical trials. Though catalyzed by the
coronavirus pandemic, this solution makes participation in these types of trials far easier for many more patients, regardless of where they live, work and study; thus ensuring richer data and better research outcomes well into the future.” says Dave Hanaman, Chief Commercial Officer and co-founder of Curavit.

About Curavit Clinical Research

Curavit is a new type of clinical research company that designs and executes decentralized – also called “virtual” trials. Curavit brings together the world’s leading researchers, enrolls previously untapped and underserved patient populations, applies machine learning algorithms to health and social engagement information, and leverages leading telehealth, patient data platform, and medical device technologies.
https://curavitclinicalresearch.com/

About eMoyo

eMoyo is a team of passionate designers, engineers, clinicians and dreamers working to make the world a better place, by creating the technology that gives the world access to quality healthcare. This includes advocating for policy change, health implementation science and the development of technology that empowers healthcare providers to reach further and do more. Founded by Dr Dirk Koekemoer, eMoyo is an ISO13485 company renowned for producing high quality, innovative technology and services. https://emoyo.net/

MEDIA CONTACT

Dave Hanaman, Chief Commercial Officer, Curavit
info@curavitclinicalresearch.com

https://emoyo.net/

https://emoyo.net/

Curavit Clinical Research officially launches with a focus on virtual trials

Feb 18, 2020
Curavit Clinical Research - Press Article

Industry veterans Joel Morse and Dave Hanaman announce the formation of a company to lead into the future of clinical trials.

Curavit was founded to help realize the potential of decentralized trials. Mssrs. Morse and Hanaman come to Curavit with over twenty five years of experience, founding, building, and running successful technology-enabled healthcare companies. https://curavitclinicalresearch.com/about

● The $70 billion global clinical trials market continues to grow , while the success rate of trials continues to decline, often due to lack of enrollment and participation by patients and doctors.
● New technologies and new approaches offer an opportunity to both increase success rates and decrease the costs of traditional clinical trials.
● Virtual clinical trials take advantage of these trends and opportunities.
● Just a small percentage of trials today, virtual trials are projected to increase geometrically due to their advantages.

“Curavit is the result of our desire to solve growing challenges to the important work of drug discovery.” said Joel Morse , Chief Executive Officer and Co-Founder of Curavit. “By combining experience, technology, and solid execution, we will bring cutting-edge research to previously untapped and underserved patient populations.” Chief Commercial Officer and Co-Founder Dave Hanaman added:
“We are fortunate to have worked with some of the most respected companies and visionary people in the life sciences industry, and are honored by the support we are receiving from them for this effort.”

ABOUT CURAVIT

Curavit Clinical Research takes a clean sheet approach to clinical trial design and execution. Optimized on a new “virtual” – or decentralized – model, the company supports patients’ participation from wherever they live, across the country, and around the globe. Curavit teams with distinguished principal investigators in specific therapeutic classes, works from archetypal investigational sites in major research hubs, leverages best-in-class industry standard patient data platforms and mobile health devices to collect, manage and protect patient data. By applying advanced data analytic algorithms to patient information and real world evidence, Curavit partners with healthcare entities to identify, qualify, and enroll patients in approved clinical trials. Curavit plans to open its first site in Boston this summer.
Connect: https://www.linkedin.com/company/curavit/
Follow: https://twitter.com/CuravitClinical

MEDIA CONTACT

Dave Hanaman, Chief Commercial Officer
info@curavitclinicalresearch.com