Tag: Virtual trials

BioClinica and ERT to Merge: Perspectives on Potential Synergies | Blog

On December 10, 2020, ERT, a clinical end-point data solutions company, announced its merger with BioClinica, a clinical trial management and imaging solutions company. The goal of the resulting enterprise will be to integrate the best of both worlds – ERT’s expertise in electronic Clinical Outcomes Assessment (eCOA), therapeutic expertise in cardiac safety and respiratory, and clinical endpoint measurement through wearables, with BioClinica’s expertise in imaging and clinical trial management solutions. The merger will equip the combined company to deliver data analytics, insights, business intelligence, virtual patient visits, and technology solutions to its clients.

In analyzing this development, we’ve taken a look at the hottest topics in the life sciences industry right now – decentralized and virtual clinical trials.

Virtual clinical trials – a revolution catalyzed by the pandemic

A virtual clinical trial is one in which certain parts of the clinical trial are conducted outside a clinical site, such as patient consent capture, trial data capture, or patient monitoring through sensors or wearables. The benefits to the pharmaceutical company include cost savings, better patient recruitment and retention, and improved data quality.

Earlier this year, we published a blog predicting that the 2020s would be the decade of virtual trials. It seems we were way off the mark – by about nine years. The year 2020 has already seen its fair share of virtual trials, as clinical trials that were put on pause due to lockdown restrictions were rescued by being converted to fully virtual or hybrid trials, such as cases in which clinical experts visited patients at their residences to collect vitals or samples, reducing delays.

#NoGoingBack

The virtual trial momentum isn’t temporary, and there’s increasing focus on virtual trials, even among investors. Not only this, many in the industry have pledged to preserve the progress they’ve made in clinical research due to the pandemic, including virtual trials.

On the same day the news of the merger was announced, the Decentralized Trials & Research Alliance (DTRA) was formed to unite stakeholders with a mission to make clinical trial participation widely accessible by advancing policies, research practices, and new technologies in decentralized patient-focused clinical research. Companies that are part of this alliance include technology vendors such as Medidata Solutions and Oracle Health Sciences, pharma companies such as Pfizer and Roche, CROs such as Parexel and Syneos Health, and others such as Amazon and the US Food and Drug Administration.

M&A and investment activity has increased, too. For example, Medable and Science 37 each received funding during the pandemic to advance their virtual trial offerings. And in November 2020, VirTrial, a telehealth platform for managing decentralized and virtual clinical trials, was acquired by Signant Health, a Clinical Trial Management System (CTMS) vendor, thus augmenting its virtual trial capabilities.

Clearly, virtual trials are a ripe area for M&A and investment activity given their disruptive capabilities and benefits. And we continue to expect more acquisitions, funding, and collaboration in this space in the near future.

What this all means for the merger

Our recently concluded PEAK Matrix assessment on clinical development platforms pointed out that BioClinica’s Cloud platform for clinical development does not have the capability to support virtual trials; we said it needed to invest in remote monitoring and eCOA capabilities to deliver on virtual trials. However, the solution does have a broad set of capabilities in the clinical, regulatory, and safety value chains.

As a result of the merger, however, BioClinica will be able to offer virtual trial capabilities to clients. ERT is one of the leading eCOA providers and through its wearable and sensor data capture capabilities, it is well positioned to conduct virtual trials in certain therapy areas. And it will be able to use the BioClinica Cloud offering to give clients a holistic clinical development experience, a win-win-win for ERT, BioClinica, and their clients.

Exhibit 1 shows the combined solution landscape.

Exhibit 1: The merger synergies

bioclinica

The merged entity will be able to showcase an end-to-end clinical development platform with enabling layers for virtual trial conduct. This move is definitely the right direction, at the most opportune time, and is just another sign of increasing interest in decentralized and virtual trials.

What are your views on this merger? Let us know your thoughts at [email protected] and [email protected].

The 2020s Will be the Decade of Virtual Clinical Trials | Blog

Virtual clinical trials – wherein trial data is collected through sensors or remote monitoring devices carried by the patient – can deliver many benefits to pharmaceutical companies, including cost savings, better patient recruitment and retention, and improved data quality.

In 2011, Pfizer conducted the first-ever randomized clinical study that managed participants using mobile phones and the internet. Over the next few years, the virtual approach waned because of limited success stories and the considerable upfront capital investment required for sensors and platforms.

However, with recent technological advances, the proliferation of wearables (smartwatch shipments have doubled in the past several years), and the FDA’s urging clinical trial sponsors to keep their research ongoing via telemedicine in the wake of the COVID-19 situation, the clinical trial landscape is ripe for disruption by virtual trials.

Indeed, as a bellwether of growing viability, the first virtual trial conference was conducted in December 2019. During the two-day event, the key discussion points were understanding the decentralized model, regulatory challenges for virtual trials, and ensuring compliance for such trials.

Enter technology companies and Big Tech

To build momentum and drive synergies, pharma companies have started to partner with technology companies to test the virtual trials model. For example, in 2018, Novartis, Sanofi, and UCB individually partnered with Science37, a tech company focused on patient-centric models for clinical research, on patient-friendly clinical trials at home. Boehringer Ingelheim followed suit in 2019.

Numerous startups that address some aspect of virtual trial requirements have emerged. For example, VirTrial, a telehealth platform that allows pharmaceutical companies and Contract Research Organizations (CROs) to create patient-centric trials by replacing some in-person visits with virtual visits, was founded in 2018. Since then, it has ramped up its capabilities and expanded internationally across 31 countries. Also in 2018, IQVIA, a leading CRO, enhanced its portfolio by launching virtual research solutions aimed at patient-centric trial design and execution. And today, numerous companies, including Clinpal, Covance, Medidata, ObvioHealth, PRA Life Sciences, and Transparency Life Sciences, boast their own virtual trial platforms.

Not wanting to be left out of this highly lucrative market, the Big Tech players are also exploring additional opportunities. For example, Apple, Best Buy, and J&J recently collaborated to launch a virtual study to gauge whether the Apple Watch could help reduce a person’s risk of stroke. Apple has also been involved in this space through its ResearchKit, an opensource software tool for medical researchers, doctors, and scientists to collect data on people suffering from diseases. Similarly, Verily, a Google sister company, has teamed up with pharma majors to modernize clinical trials and improve patient engagement and recruitment, and aggregate data from wearable devices.

Technological advances

Of course, much of virtual clinical trials’ success lies in the strength, viability, and rigor of the technologies that support them. The picture below shows the technologic interventions that enable the virtualization of a clinical trial.

Technologies that enable the virtualization of clinical trials

And fortunately, the above technological interventions speed up patient recruitment, improve patient adherence and monitoring, and eliminate data siloes by having a single source of truth in the cloud – ultimately enabling a smooth and virtual experience during a trial.

The road ahead

Delivery model and technological advances and co-innovation among stakeholder organizations have set the stage for trials to transition from traditional to virtual. Technology players are more capable, risk-tolerant, and knowledgeable than before, leading to increased trust and synergies with pharma companies. While pharma companies are resorting to the motto of “fail fast, win cheap,” virtual trials hold great promise to revolutionize the trial landscape. And what better time than now, when the field is ready, and the fruit is ripe?

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