Pratia, purported to be the largest network of clinical research sites in Europe, has inked a partnership with VirTrial to complete their Virtual Trial Capable training and establishing them as the first site network in Europe trained and certified as “Virtual Trial Capable” and ready to conduct decentralized clinical trials (DCT).

What is the VirTrial Training?

Their training program includes four modules that clinical research professionals complete to demonstrate competency in general telemedicine etiquette and guidelines, as well as how to utilize the VirTrial platform. Apparently, once the Site participants pass the training, they are able to receive a “Virtual Trial Capable” certificate and badge to highlight to sponsors and CROs that they are prepared to conduct hybrid decentralized clinical trials.

Who is VirTrial?

Founded in 2018 and based in Scottsdale, Arizona, VirTrial is a technology company that leverages an existing telehealth platform to transform the clinical trials industry. TrialSite News suspects they have in-licensed an established telemedicine system.

The platform offers a patient management program that combines video, text and email, offering pharmaceutical companies and CROs the ability to create patient-centric trials by replacing some study visits with virtual visits.

Their vision is to seek to transform the industry to move toward at least 25-50% of sites visits to a remote/virtual “hybrid model.” A small venture of under 10 employees (according to LinkedIn), their CEO Mark Hanley was CEO of CRO Radiant Research. Their VP of Business Development Amanda Rangel also founded a clinical research site network.

VirTrial was formed in August of 2019. Their core management team (Kim Kundert, Amanda Rangel and Mark Hanley) all came from Radiant Research/Synexus (largest site network in the US/largest site network in the world).

In their tenure at Radiant and Synexus, they were involved in >10,000 clinical trials. Therefore, they have extensive knowledge of patients/patient needs as well as sites/site needs.

Their model has always been a hybrid approach (combining in-clinic visits with a portion of remote visits via telemedicine) to reduce patient burden (decrease the number of times a patient has to go to the clinic) and create efficiencies for research sites at the same time. They understand how important research sites are to clinical trials, and technology cannot replace the human element of connections.

Coming from the site side of things, they understand how things (ie, technology- example- edc and e-diaries when they first came out) are normally pushed down to the sites without any input from the end users- sites and patients.

Starting just a few months ago in August 2019, they have pivoted toward a virtual certification and training-based company and perhaps virtual clinical trial consultancy that can then lead to greater brand recognition, differentiation and positioning and ultimately springboard for greater revenue generating opportunity.

The Move to Certification as a Path to Win Convert Sites & Attract Sponsors?

In August, 2019, VirTrial attended the Society for Clinical Research Sites (SCRS) annual conference and announced a new training and certificate program to help research sites prepare for hybrid clinical trials. which include a combination of virtual and in-person visits. They made an offer undoubtedly many couldn’t refuse: the certification was free to all SCRS member sites in the U.S. and abroad.

The training and certification offering included the already announced four modules—hoping to prepare sites to become “certified as Virtual Trial Capable” and secure the Virtual Trial Capable Certificate and badge, which they tout can be used to essentially convince sponsors and CROs as to their capabilities involving virtual clinical trials. In fact in their SCRS press release CEO Hanley noted “As a Circle of Sustainability Partner with SCRS, VirTrial is committed to research site sustainability and that requires the use of technology to augment traditional studies.” He noted that “Most future protocols will include a telemedicine component, and we want to help ensure sites are prepared to handle that. Our target is to have 30,000 members and 9,000 sites trained on virtual trials.”

The HyperCORE Deal

The HyperCORE clinical research network was covered by TrialSite News back in April 2019. They are a network model, meaning the various sites don’t have any legal ties other than an agreement to collaborate. Well, it turns out they were the first ones to sign up for the VirTrial training and certification. Was it a marketing play or does HyperCORE in fact see a number of hybrid protocols on the horizon? We suspect it could have started as the former but become the latter.

In the press release, CEO Hanley noted VirTrial was “taking a grass-roots approach to decentralized clinical trials by aligning with sites and helping them prepare for the shift to traditional hybrid trials where some visits are in person and some are remote.”

ACRP Offering

The Scottsdale group also offered the Association of Clinical Research Professionals (ACRP) members, the option to become trained and certified. After all, many of their members work at clinical investigational sites.

The Most Recent Pratia Deal

Now Pratia has signed up to achieve the certification and serve its “Mission to facilitate access to healthcare to improve the quality of life and the sense of security of our patients. Embracing telehealth technologies that enable larger patient population to participate supports our goal and we’re proud to be the first network in Europe to offer this benefit to sponsors,” reported Malgorzata Gerjatowicz-Osmanska, Managing Director of Pratia. Ms. Gerjatowicz-Osmanska continued, “Our network is expanding across Europe and we plan to maintain 100% Virtual Trial Capable status with VirTrial to best serve our patients and phrama sponsors.”

Pratia, established in 2012 in Poland, has grown steadily by unifying the best research sites in Europe. By 2014. they were acquired by Polish health-centric corporate roll-up venture NEUCA Capital Group, which offered financial stability—something many independent clinical investigator sites struggle with.

The First Public Sponsor Deal

Just this month, VirTrial was awarded an FDA approved decentralized clinical trial with Hope Biosciences. Apparently, the FDA approved the “hybrid decentralized clinical trial (DCT)” with the sponsor. The study involves the sponsor’s autologous, adipose-derived, culture-expanded mesenchymal stem cells (HB-adMSCs) for the treatment of spinal cord injury/disorder (SCI/D). Apparently the study protocol incorporates remote visits via the VirTrial telehealth platform.

They noted in their recent press release that hybrid DCTs can eliminate barriers to participation for SCI/D patients who have limited access to travel or suffer from the physical toll travel takes on them. They also noted that remote visits limit the demand for all visits to be done in-person. At remote visits, a registered nurse visits the patient in their home and in conjunction with the physician, who is connected via the telehealth platform, conducts a physical exam. Once the physician gives the approval, the RN can administer the stem cell infusion to the patient in their home. TrialSite News hoped the actual study identification number or title would be identified for review.

Certification Becomes Building Block for VirTrial to Revenue Model?

We believe VirTrial has made an interesting and, ultimately, a gutsy move to build a bigger long term business. Why not create a certification program and certify a whole industry!?

A certification program is a defined set of components or training programs offered by an organization for members to prove they have achieved a measured level of knowledge within a designated timeline. Apparently, any organization can set up a certification program. In fact, according to one resource, the key benefits to a certification program include 1) Build Brand Awareness 2) Cultivate a Community 3) Create another Revenue Stream 4) Build Authority and Thought Leadership and 5) Validation (for employees).

What are Telehealth Platforms doing with Clinical Trials?

Many telehealth platforms exist in the clinical trials space. For example, Science37’s platform is built around telehealth. TrialSite News discussed the movement started by Science37 and touched on some of their significant issues including too much cost. Key vendors out there tout their wares for clinical trials such as American Well.

Some Final Thoughts

First, we cannot be certain if the principals at VirTrial have the depth and breadth of expertise in telehealth technologies to successfully role out an authoritative certification to an entire industry worldwide. They are a very small start-up with what we believe to be less than ten people. We doubt that they generate any substantial revenue at this point and they have not exhibited any considerable growth as measured by significant headcount growth. Moreover, there are other sophisticated operators out in the market such as Science37 that have done significant business with big pharma and have built their solutions on telehealth platforms.

On the other hand they have incorporated the kind of out-of-the-box, big thinking that is required of successful entrepreneurs. First, their small core group possess quite a bit of deep clinical trial domain expertise. Second, they have a track record in industry and keep a considerable contact base for business partnerships and deals. Third, they are addressing a fundamental need. In fact, on this point TrialSite News CEO & Publisher Daniel O’Connor has presented to two Society of Clinical Research Associates (SOCRA) about coming waves of technology that site coordinators (and investigators) need to prepare for and understand—included in the talks was a focus on telehealth technologies. Fourth, they are thinking big—establishing a framework for an industry wide certification that prepares sites to engage with sponsors; fifth, in less than a year they have engaged and inked significant partnerships—albeit they are probably free or at cost; and sixth, they have announced a direct industry sponsor deal with Hope Biosciences.

From experience, TrialSite News principals can attest it is challenging to build a new venture inclusive of a new underlying model serving a conservative, risk averse industry such as drug development space. Undoubtedly, there is a challenging path ahead toward a sustainable, breakout business model. But TrialSite News offers words of encouragement that sites should take them up on their offer and sponsors should consider reviewing their offering to consider their telehealth-enabled hybrid strategies for decentralized clinical trials.

Call to Action: If you are a site, why not see if you can cash in on the free offer with VirTrial for a Virtual Trial Capable training and associated certification? Sponsors, why not consider VirTrial as a new study vendor?

Source: VirTrial

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