COVID-19 and mobile technology platforms, not to mention virtual trials, go hand-in-hand and Medable consequently is on a tear inking a strategic alliance with LabCorp (NYSE:LH), one of the world’s largest contract research organizations (CRO). Just recently, Medable signed another partnership arrangement with PPD. Now Covance, the drug development business of LabCorp, will expand more aggressively into decentralized trials, leveraging the technology capabilities developed by the Silicon Valley startup. To close two prominent CROs within a month or two means Medable is surely on to a significant trend.
TrialSite News break down this arrangement, based on publicly disclosed information, and delves into Medable to explore the potential for this relatively new digital clinical entrant. COVID-19 has transformed the clinical trials ecosystem. There will be a radical shift to embrace virtual, decentralized clinical trials as hundreds of studies have been stalled or suspended; lockdowns and partial lockdowns are still in effect in many locations and even as communities open back up, they will be careful—ready to have to shut back down again. Hence the clinical trials landscape is rapidly changing and trials need to be more accessible and more convenient for participants. In the press release, Medable proclaimed that this partnership leads to the first data-driven, decentralized trial system.
The large CRO subsidiary Covance seeks to expand its decentralized trials technology capabilities as the entire clinical trials landscape changes due to the COVID-19 pandemic. Moving forward, most in the industry project a rapid growth in the adoption of decentralized clinical trials, often known as hybrid or virtual clinical trials.
What does Covance have in mind with this new alliance in place?
Covance will capitalize on the mobile, smart-based app technology powered by Medable’s modular software platform, in order to offer patient and site app interfaces—hence supporting a more seamless move to decentralized trial access, engagement and collaboration.
What is a core benefit of offering patients and sites interfaces via the Medable modular software platform?
This will offer sites and patients access to applications that will allow patients to participate in decentralized clinical trials. Moreover, the platform supports data and system interoperability (e.g. via APIs/web services, and data standards) and facilitates remote data collection and engagement between patients, sites, and clinical investigators.
Wil LabCorp leverage its internal business line technology applications and surface them via the Medable modular software platform?
Yes. Bill Hanlon, PhD, present Enterprise Solutions, Covance declared in the recent press release that “Working together, we can apply the full capabilities of LabCorp Diagnostic business, Covance, and our technology ecosystem to extend patient access, improve the patient experience, and accelerate timelines for clinical development.”
Hanlon reminded the market that Covance, a full-service CRO, “will continue to play a critical role as aggregators and integrators to provide customers with the access, flexibility and scale necessary to enable global decentralized studies, and to rapidly innovative in ways that improve the patient experience and trial efficiency.”
Has LabCorp already embarked down the path of decentralized trials?
Yes. In 2019, the company announced its cohesive decentralized clinical trials solution integrating unique capabilities from across Covance and LabCorp Diagnostics. This included a patient-centric ecosystem of conveniently located resources, such as LabCorp’s U.S.-based Patient Service Centers and LabCorp at Walgreens locations, global partnerships with reputable retain pharmacies, as well as home health phlebotomy and nursing service providers, all connected via best-in-class technology platform.
What does the deal look like?
Nothing is disclosed. First and foremost, there is undoubtedly some payment structure—as Covance wins business, perhaps a revenue split is viable based on some pre-negotiated formulas. Moreover, there could be engineering fees, cloud hosting fees and more. This deal affords Medable the opportunity will penetrate the Covance client-based learning in more detail the “ins and outs” of conducting decentralized clinical trials and enable them to ”deepen patient engagement and reduce burden for trial participants,” reports Medable CEO Michelle Longmire, MD, which ultimately she declared “will accelerate timelines.”
Is there a description of the joint offering?
Yes, Covance has updated its website to include a description of hybrid and virtual trials with partner Medable.
What does Medable do?
They describe their mission as one to reduce clinical trials times by 50 percent. The company’s software platform replaces stagnant, siloed systems with integrated digital tools, data and interfaces to accelerate clinical trial execution. They work with patients, healthcare providers, biopharma sponsors and CROs to improve patient access and outcomes.
Business & Finance
Privately held, the company was founded in 2015 by James Sas, Michelle Longmire and Tim Smith. They have raised about $45 million. TrialSite News recently reported on their $25 million funding from early-stage health care and AI fund GSR Ventures, with an amount from PPD—a Covance competitor—as well. They recently had Sunny Kumar, MD, a GSR Ventures’ partner, join them.
What are the Medable products—the Solution?
They have developed a “data-driven” decentralized platform for clinical trials. In a way, Medable can be thought of as a turnkey mobile “middleware” in the cloud that serves as an intermediary or broker between (on the one hand) a myriad of different systems including 1) External Systems and 2) Medable Patient and Site Aps. For example, External Systems can include EDC systems, Real-World Data systems, EHR/EMR and Lab data, Claims data and more. While on the other hand, the Medable Patient and Site Apps include eCOA, ePRO and consent, connected devices, eSource, image capture and more.
The Integrated Data and Study Platform can consume all of the aforementioned data sources and offer a range of platform services and data processing services. Platform services include a) data visualization, b) APIs, c) Real-time analytics, d) AI, and e) machine leaning. While the Medable data processing services help the clients not only ingest all the data from External Systems and from Medable patient and site apps, they also curate, map, normalize and standardize the data. They claim that all of this occurs in a FDA, GcP, GDPR, HITECH/HIPAA Act complaint environment.
Many different competitors offer some or part of these solutions but few offer an end-to-end mobile-naive platform purpose-built for decentralized clinical trials. Regardless, different clinical technology vendors are working diligently to not only expand their offerings but also compete in the decentralized study site space. Classes of competitor include eClincial vendors (Bracket, ERT, CRF Health, software/cloud software company consolidator Oracle, Veeva, Dassault (Medidata), and decentralized clinical trials tech vendors (Science37), and CROs marketing end-to-end solutions (IQVIA, ICON, Syneos Health, Parexel, etc.). Note, dozens if not more smart phone-based apps have been developed, not to mention some considerable technology solutions out of major academic medical centers.
Moreover whole new disruptive models have emerged, some as research as a care option platforms (Elligo Health, Javara), research site network (TriNetX, Verily), and even more disruptive models, such as direct sponsor to patient DNA mining such as 23andMe. Many new entrants enter the market each year.
Challenges with Decentralization
Despite the fact that the clinical trials industry is moving rapidly into the world of decentralization, the industry is notoriously conservative, highly regulated, and dominated in some cases by a handful of vendors. What follows are some known challenges with the move to decentralization:
- Guidelines and compliance expectations for decentralized studies may still be lacking. Many large pharma, biotech and device companies must transform their internal policies, procedures, SOPs, training, etc. In some cases, old practices die hard—mix that with steep learning curves and change management challenges, and obstacles and roadblocks emerge.
- Rules, regulations, and laws can change by country and even by state in the U.S. No matter how nice and clean Medable can make it look, it isn’t easy integrating and harmonizing lots of data. Add highly regulated data such as IXRS and things get really tricky. Send investigator product to the patient and watch the chain of custody issues surface. Compliance and regulatory considerations and the need for new systems may arise in some cases.
- All technologies must be qualified and validated. What if some of the systems are difficult for traditional processes—are regulators and clinical quality assurance ready to truly let their guard down and mind open? And what happens to that critically important relationship involving the patient, principal investigator, coordinator and others? There is a human element that patients’ value.