In the News

President & Chief Commercial Officer | Curavit

Nov 15, 2021
Dave Hanaman

NEXT FRONTIER: The next frontier for clinical trials is in-silica research, also – confusingly – called virtual trials. In this future of research, “subjects” are computer models, data is real world data (RWD), and the experiments are conducted through computation – not human observation and measurement. There are already some good examples of this. The Economist recently reported on the one from the UK, but it will be a very long time before this is a significant disrupted to clinical research.

Curavit Clinical Research announced the appointments

Oct 20, 2021
Jay Collier

Curavit Clinical Research announced the appointments of Jay Collier, as Chief Operating Officer, and Candice Del Rio, as Director of Clinical Operations.

Insights into Definining Decentralized Clinical Trials

Oct 20, 2021
Dave Hanaman

Decentralized Clinical Trials (DCTs) have taken the main stage in the clinical trials industry, which was significantly facilitated during the pandemic. However, similar to the initiation of risk-based monitoring (RBM), the concept of DCTs is at an infancy stage, and many enterprises are competing to make their mark in the field. This prompted the formation of the Decentralized Trials & Research Alliance (DTRA) to help better define and advance DCTs. In this article, Dave Hanaman, Co-founder of Curavit, will discuss his perspectives on DCTs.

Moe Alsumidaie: What is a Virtual CRO (VCRO)?

Dave Hanaman: Co-founder Joel Morse and I conceived the company from our experience at C3i, where we spent 20 years at the intersection of digital technologies and clinical research. We saw this space evolving for years and wanted to disrupt research by positively applying technology in new ways. So we launched Curavit officially in November 2019 and became the first virtual CRO—a contract research organization dedicated exclusively to designing and executing decentralized clinical trials.

As a VCRO, Curavit runs fully decentralized trials from start to finish and acts as a virtual site, managing the decentralized components of a hybrid clinical trial. We leverage industry-leading digital technologies, devices, and our cloud-based DCT platform to centrally capture, aggregate, manage, and analyze trial data for sponsors. Curavit also brings specialized therapeutic expertise for decentralized trials to ensure the most proficient minds and the best technologies are applied to every research study.

As a VCRO, Curavit runs fully decentralized trials from start to finish and acts as a virtual site, managing the decentralized components of a hybrid clinical trial. We leverage industry-leading digital technologies, devices, and our cloud-based DCT platform to centrally capture, aggregate, manage, and analyze trial data for sponsors. Curavit also brings specialized therapeutic expertise for decentralized trials to ensure the most proficient minds and the best technologies are applied to every research study.

DH: Yes, and the technology is catching up to the vision. In 2007, Veeva introduced cloud-based CRM to an industry desperate for lower-cost technology models because so many major brand-name blockbuster drugs were coming off patent. Veeva’s well-touted success is an example of the right solution at the right time. Decentralized trials are similarly destined, supported by developments in IoT, wearables, and big data. People have been working to make DCT a reality for years, but the technology is finally maturing and readily available while the industry is calling for a greater focus on patients and access to trials for all. So once again, we have a case of the right solution at the right time.

MA: Are there concerns around data privacy and what precautions is Curavit taking to protect it, especially now where the U.S. and many Western nations are under attack by foreign hackers. What can be done to address those concerns using a DCT model for research?

DH: From banking to life sciences, every industry is extremely concerned about protecting data. As in most things, there are tradeoffs. Decentralized trials that do not involve sites can be an advantage in limiting data risk. DCTs can be much more secure in many ways because you can centralize data in very safe, modern cloud systems. That is what Curavit is doing.

Curavit’s platform has been purpose-built for decentralized trials with proven, industry-leading software. HIPAA compliance and validation are built into the individual tools as well as the overall platform. No corners were cut in terms of applying modern cyber defenses.

MA: Part of Curavit’s vision is to make research more accessible across all the demographics. How are you expanding clinical trials to those demographics through DCTs?

DH: First, DCT technologies and processes are fundamentally more suited to reaching previously underserved or underrepresented patient populations. It’s easier to expose more people to the opportunity to participate in research across social media, digital communities, and websites supporting specific diseases or conditions.

Second, and more specifically, DCTs leverage community-based outreach. For example, we partner with Clinispan out of North Carolina whose purpose is to recruit underserved populations. Par 80 in Boston partners with community health centers serving minority populations. These efforts reach out to minority populations to include those who distrust or have not been previously exposed to research.

Third, we have had ongoing discussions with a global pharmaceutical company interested in Native American populations that embody two distinct underserved groups: indigenous and rural populations.

MA: Where do you see DCTs going in the next ten years?

DH: Optimistically, in 10 years, we won’t think of DCTs as unusual because the technologies and processes will be commonplace. DCTs won’t be any more novel than computerized businesses are today.

Most data capture will be in the cloud a decade from now, and DCTs will enable a more burdenless patient research experience. To clarify, that doesn’t mean face-to-face interactions with physicians will go away. Even in complex therapeutic areas like oncology, there’s plenty of opportunities to use digital technologies to gather new data and reduce patient burden. We won’t think of DCTs as a distinct subset. In 2031, DCTs will have disrupted clinical research in profound ways that are better for all patients, better for all sponsors, and ultimately better for public health.

Decentralized Clinical Trials: What Therapeutic Areas are Ripe for All-Virtual?

Oct 20, 2021
Pam Diamond | Curavit Clinical Research

Before the pandemic, a December 2019 Industry Standard Research survey found that 38% of pharmaceutical sponsors and contract research organizations (CROs) expected virtual trials to be a major component of their portfolios, and 48% expected to run a trial with most activities conducted in participants’ homes. One year later when attendees at McKinsey’s Clinical Operations Roundtable were asked the same questions, the responses were 100% and 89%, respectively.

Today, most are asking what trials and what aspects of trials can be effectively decentralized and to what degree. Fully virtual or decentralized clinical trials (DCTs) typically handle all enrollment processes and assessments in a patient’s home, enabled by end-to-end digital tools and involve the self-administration of medicines. This model is gradually migrating from smaller, early-phase and post-approval studies toward larger pivotal trials, such as Otsuka and Click Therapeutics’ landmark fully remote clinical trial to investigate the effectiveness of digital therapeutics in reducing symptoms in adults diagnosed with major depressive disorder (announced in Feb 2021).

In the near term, sponsors, investigators, and CROs expect fully virtual trials to remain limited to a narrow set of use cases, such as a well-characterized drug with few adverse events in a mild indication, with end points suited to remote measurement. Long-term, however, fully virtual trials will be more widespread—especially in certain therapeutic areas such as rare disease, mental health, central nervous system, neurodegenerative and others that require patient populations that can’t physically travel or don’t live near a site.

Ultimately, the therapeutic area alone shouldn’t determine a trial design. Rather, each trial should be designed for-purpose and centered on patients. The target patient population, treatment, and indication will primarily determine whether a trial is fully virtual, hybrid or a traditional site-based trial. Even so, there are defining patient population characteristics in many therapeutic areas that can make some studies more likely candidates for all-virtual research.

Here are five therapeutic areas that are particularly apt for an all-virtual research approach, and that can serve as an entry point for hesitant sponsors interested in exploring this growing DCT model.

Diabetes—More than one in 10 Americans have diabetes and one in three or 88 million adults are prediabetic. Given the disease’s prevalence and its widespread geographic reach including many rural areas, diabetes is ripe for fully virtual research. Blood glucose values can be monitored continuously with wearable devices attached to the patient’s skin and automatically uploaded to a central platform in the cloud for easy access by trial investigators, sponsors, and the patients themselves.

In addition, the propensity of patients with Type two diabetes to be elderly or struggle with obesity can make it difficult for patients to travel to trial sites. These patients often have vascular problems which also can also hinder mobility. Further, diabetes is rampant in certain demographics such as Native Americans who are twice as likely to have diabetes as whites and often live in remote rural areas far away from the nearest clinician. Virtual trials bring lifesaving treatment to these patients and further the development of treatments that reflect the unique needs of a more representative population.

Cardiovascular—With wearable devices, including Apple watches, that monitor increasingly more sophisticated and wider range of cardiovascular endpoints remotely, research focused on cardiovascular diseases are apt for a fully virtual trial design. These devices accurately monitor and measure cardiac events and catch issues, such as atrial fibrillation (a common type of sustained cardiac arrhythmia) and ventricular tachycardia (abnormally fast heart rate) to alert the patient and remote physician in real time. Even some clothing items, such as bras, have sewn-in heart monitors! There are other devices that can be worn continuously for months at a time to capture more sophisticated measurements and automatically send data into the cloud. The same is true when it comes to managing blood pressure.

Like diabetes, cardiac patients are in all corners of the world and often many hours from central research sites and—due to their condition—may have mobility challenges and concerns. Virtual trials extend access to the millions living with heart disease and high blood pressure. Further, the data gained from continuous and multiple-symptom monitoring of cardiac patients is dramatically more useful in comparison to the less-reliable, one-hour, single-symptom testing completed at a site once a month or every few months. Heart arrhythmia often occurs only intermittently so it may not be picked up at the occasional site visit. Today’s wearable devices monitor blood pressure, heart rate and rhythm, and oxygen saturation levels as well as activity level (steps taken) so researchers can superimpose different measurements depending on what endpoint is being studied or combine multiple measurements for more meaningful information.

Central nervous system (CNS) diseases—Parkinson’s Disease, Multiple Sclerosis, Alzheimer’s disease, and other CNS diseases may dramatically impact patients’ mobility as well as hamper caregivers’ ability to bring affected loved ones to frequent clinician visits. All-virtual trials open these patients up to potential opportunities they might not otherwise ever have for a treatment.

Like cardiac wearable devices, there are an increasing number of new technologies that allow researchers to measure novel endpoints of patients in the comfort of their own homes and in more realistic life settings outside of a doctor’s office. Devices can continuously measure number of hand tremors per minute, for example, so a novel endpoint could be the reduction of hand tremors which was not as easily studied in traditional trials.

An electroencephalogram (EEG) is a widely used non-invasive method for monitoring the brain but has historically been a large and bulky technology, restricted to the monitoring of subjects in a lab or clinic while they are stationary. Today, we can use a wearable EEG, which overcomes these limitations and allows the long-term, non-invasive recording of brain signals at home.

Neuromuscular trials—Like patients with CNS disorders, patients struggling with neuromuscular diseases, including Duchene Muscular Dystrophy may have severe mobility challenges that make it difficult to make regular clinician visits. Fortunately, there are advanced activity monitors that do not interfere with movement on these patients such as ankle bracelets that can record various measurements continuously to, say, show how much activity a person takes part in over a period. Red Nucleus Clinical’s iTakeControl platform is a clinically approved solution that enables HIPAA-compliant video assessments of patients, live video research visits and audio recording to provide richer audio/visual data that is also auditable for compliance purposes.

Decentralized Clinical Trials Poised to Expand Their Reach

Oct 19, 2021
Dave Hanaman

An understanding of human nature suggests that in a post-COVID-19 era for clinical trials, the pendulum may temporarily swing away from the increased adoption of decentralized clinical trials (DCTs) and hybrid approaches that we’ve been witnessing and revert to something more closely resembling the traditional, in-person trial conduct practitioners and patients had been used to before 2020. However, Dave Hanaman, chief commercial officer for Curavait Clinical Research, sees “steep continued growth” in the years to come for new technologies and approaches that he believes can significantly advance the quality and reach of clinical trials.

“DCTs present a new opportunity to meet patients wherever they are,” says Hanaman. The approach they offer represents “an effective way to bring the trial to the patients,” he adds.

Acknowledging some industry “growing pains” as hybrid trials and DCTs have begun to take hold, Hanaman warns that some hybrid approaches are “the worst of both worlds,” with too heavy a physical footprint and overuse of technology.

However, Hanaman sees “strong levels of adoption” for hybrid trials in the next five to 10 years. “Much of the resistance has dropped,” he explains. “I think their use will be taken for granted” in the years to come, he says.

Hanaman is excited, too, about how hybrid trials and DCTs can expand the reach of clinical trials. In addition to traditionally underserved patient populations like African Americans and Hispanics, Hanaman notes the new technology and approach could improve trial access for native American and rural white populations. “Native American populations are often very far away from physical research sites,” he notes.

Further, internet coverage, long an obstacle to increased use of telehealth and DCTs, has improved in many of even the most geographically remote parts of the United States, Hanaman says.

DCTs and hybrid trials represent “a tremendous opportunity for patients and science,” he says. “I see so much more enthusiasm for [such approaches] to be included in trial design, and [they] will help us better reach the patients we’ve been missing.”

Meet The Disruptors: Dave Hanaman Of Curavit Clinical Research On The Three Things You Need To Shake Up Your Industry

Oct 11, 2021
Dave Hanaman

As

Thank you so much for doing this with us! Before we dig in, our readers would like to get to know you a bit more. Can you tell us a bit about your “backstory”? What led you to this particular career path?

At my previous company, my co-founder, Joel Morse, and I spent 20 years at the intersection of clinical research and digital health technology, working with the world’s leading pharmaceutical companies. We became very interested in the ways that these technologies and processes could benefit patients, researchers, and healthcare organizations. I am very happy to be working with him and several other former colleagues now at Curavit, which launched in 2019.

Can you tell our readers what it is about the work you’re doing that’s disruptive?

At Curavit, we are designing and executing decentralized, or “virtual,” clinical trials, which are the application of digital technologies, wearable devices, internet-of-things, innovative trial design, and supportive regulation to increase the speed and fidelity of clinical research, while simultaneously attracting previously undeserved patient populations.

Can you share a story about the funniest mistake you made when you were first starting? Can you tell us what lesson you learned from that?

While not exactly a “funny” story, I have one that was completely unexpected. We announced Curavit at a major clinical research conference in January of 2020, when the industry was breathlessly predicting that 10% of all trials would be “virtual” in ten years. No one foresaw the impact of the pandemic and the unprecedented forced adoption of decentralized trials within months. We found ourselves suddenly accelerating toward our goals with massive tailwinds, but also buffeted by lots of noise and turbulence from the hype. We again learned the lesson that “the first casualty of battle is the plan,” and that you have to stay committed to the outcome while adapting to the things you can’t control.

We all need a little help along the journey. Who have been some of your mentors? Can you share a story about how they made an impact?

I learned so much from the men and women I served with in the Navy. From my Marine drill instructor, to the commanding officers I worked for, to my squadron mates and colleagues, they continue to inspire and motivate me every day. And of course my family; I have always enjoyed the full support of my wife and sons through the good, bad, and most of all uncertain times associated with being an entrepreneur.

In today’s parlance, being disruptive is usually a positive adjective. But is disrupting always good? When do we say the converse, that a system or structure has ‘withstood the test of time’? Can you articulate to our readers when disrupting an industry is positive, and when disrupting an industry is ‘not so positive’? Can you share some examples of what you mean?

I believe that “disruption” is a neutral word and that in practice it usually results in both positive and negative outcomes, depending on one’s perspective. For decentralized clinical trials (DCT), a good example might be the impact on sites. Are DCT’s “site-less” trials? Sometimes. Does that mean that some sites are negatively impacted by DCTs? Yes. But the flip-side of that may be reducing patient burden and increasing diverse enrollment, and those are positives. Furthermore, as with most disruption, it won’t be that simple. In this example, I believe some sites will prosper by embracing DCT technologies and processes, benefiting themselves as well as patients.

Can you share 3 of the best words of advice you’ve gotten along your journey? Please give a story or example for each.

One of our sales people once said, “If you’re explaining, you’re losing!” This means your value to your customers has to be clear and compelling.

An early advisor to my first company said, “Sometimes, you gotta tell ’em the baby is ugly.” In other words, don’t be afraid to see and speak the truth.

And recently, one of our current investors (and an advisor to our company) reminded me that my ultimate job is to detach and put myself in our customers’ shoes. Our success depends on our ability to meet and exceed customer needs and expectations over the long term.

We are sure you aren’t done. How are you going to shake things up next?

Curavit is my “next” right now. We are in our formative stage and are building out our team. We have an opportunity to do a lot of great work for the next few years and help shape the future of clinical research. That’s plenty for now, so no clear plans for a “next thing” just yet!

Do you have a book, podcast, or talk that’s had a deep impact on your thinking? Can you share a story with us? Can you explain why it was so resonant with you?

I usually read fiction or philosophy every night, even if only for a few minutes. In the gym or the car, I’ll listen to podcasts and audiobooks on a broad (and non-business-specific) array of topics often touching on history, exploration, geopolitics, and leadership. Right now I’m listening to the audio book “A Hunter Gatherer’s Guide to the 21st Century,” and just finished a 9/11 retrospective podcast series on Michael Morell’s  podcast. Apropos of this interview, a keynote presentation that still resonates with me was one I heard years ago by Dr. Clayton Christensen on his seminal book, “The Innovator’s Dilemma.” That talk still informs my thinking around our strategy at Curavit today.

Can you please give us your favorite “Life Lesson Quote”? Can you share how that was relevant to you in your life?

I love quotes, and keep a list of my favorites. In this context, I’ll pick Theodore Roosevelt’s famous words found in “Man in the Arena.”

“It is not the critic who counts, not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. The credit belongs to the man in the arena, whose face is marred by dust and sweat and blood, who strives valiantly…who knows the great enthusiasms, the great devotions, who spends himself in a worthy cause, who at the best knows in the end the triumph of high achievement, and who at the worst, if he fails, at least fails while daring greatly, so that his place shall never be with those cold and timid souls who have never known neither victory nor defeat.” — Teddy Roosevelt

The most rewarding aspect of being an entrepreneur for me is commitment in the face of adversity and uncertainty which TR captures so well in that speech.

You are a person of great influence. If you could inspire a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger. 🙂

It would simply be to encourage people who are considering a different path to take the risk of engaging in a new venture. Of course we should plan and prepare, but eventually one simply has to make a leap of faith.

How can our readers follow you online?

You can find me and the rest of the Curavit team and follow our progress at https://www.linkedin.com/company/curavit/ and https://www.linkedin.com/in/davehanaman/.

This was very inspiring. Thank you so much for joining us!

 

Curavit joins decentralized trials group, predicts demand will keep growing

Oct 5, 2021
Curavit joins decentralized trials group, predicts demand will keep growing

Curavit has joined the Decentralized Trials & Research Alliance, an industry-backed non-profit organization focused on the promotion of remote studies.

Membership of the group will see Curavit take part in the development of the fast growing the decentralized clinical trials market according to co-founder, president and chief commercial officer, Dave Hanaman.

“DTRA provides a broader platform for Curavit to discuss the innovations and research improvements that we are driving for our clients. Curavit will also have the benefit of collaborating with other innovators to solve new or emerging challenges in a way that is meaningful for the entire industry.”

Demand for decentralized trials has increased significantly in recent years – particularly since the pandemic – Hanaman told Clinical insider and predicted demand would continue.

“Curavit sees demand for DCTs daily in the form of customer feedback. Clients are developing long-term plans to leverage decentralized components in most of their trials. COVID-19 changed the industry’s approach, impacting everything from long-range planning to execution and it doesn’t seem like we are going back to traditional methods.”

He added, “Today, most trial designs have at least on decentralized component included and every large pharmaceutical company Curavit has spoken to over the last year has established a DCT group or team – often referenced as innovation team, trial optimization group, digital team or other similar nomenclature denoting DCTs.”

Curavit was established in 2020 in a bid to tap this growing section of the market. Last month the CRO expanded its sales team in a bid to broaden its service.

Hanaman said, “Curavit is a new company and establishing its sales force from scratch, so we need team members to support the demand. Prior, just Curavit founders have been managing client inquiries and working with clients to ensure long-term satisfaction and responsiveness.

“With our growth, that is not sustainable, as the Curavit leadership also need to devote time to helping to develop unique therapeutic-area-specific solutions for our clients.”

Image: Stock Photo Secrets

 

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