Rethinking the Clinical Trial Patient and Site Experience as a Result of COVID-19: Webinar Insights and Q&A Recap

The earlier days of the surging pandemic seem like it was both yesterday and forever ago. Given that COVID-19 has impacted everyone around the globe, I’m guessing that many of you reading this may feel the same way.

Throughout the pandemic, I’ve been working remotely, separated from colleagues, friends and family, and empathizing with folks who are on the front lines each day. How can I help, or in the case of Greenphire, how can we help? How can we do our part right now?

We recently conducted a webinar that recapped just that – how the industry has been impacted by COVID-19 and how Greenphire can help. In this blog, I recap recent our recent site survey, new solution enhancements as well as had an interactive Q&A session.

Invoking the Site Voice

At Greenphire, we build solutions that help people in life science research do their jobs effectively. To focus our internal resources on solving the right problems, we needed to really understand the extent and impact of the issues at hand. The most important next step was to talk to as many sites as possible and  understand what they felt was their biggest struggles and challenges right now, and so we could use that information to focus our resources on solving the right problems to provide real value.  We quickly pulled together the most meaningful survey that we could, with enough targeted questions to identify some real issues yet without hopefully overwhelming the responder.

Within 24 hours, our survey amassed responses from more than 1,700 sites around the globe.  At a high level, I would summarize the responses into two broad categories:

• Patient Convenience: There was a clearly expressed need for more constant communication with patients, a need to really find ways to continue engagements with patients, even in the face of new reality which is that in many cases, the patient cannot leave their home.
• Site Solvency: It is no secret that many sites have faced cash flow constraints for years, well before this pandemic struck, but the current events are really amplifying the operating cash constraints that sites are facing internationally.

We created this infographic on the survey statistics.

The remainder of the webinar recapped deeper survey data expressing patient and site needs as well as how Greenphire rallied in a very short amount of time to reprioritize our IT innovation roadmap to deliver new solutions to continue clinical trials in the face of COVID-10. There are several enhancements still in development, but on the webinar we announced these exciting product updates:

• ConneX Patient Direct: New service allows clinical trial sites around the world to safely transport medications, equipment, and healthcare professionals to patients’ homes, ensuring needed patient support and enabling clinical trials to continue
• ClinCard Direct: We can now offer direct-to-patient card shipments – essentially removing burden from the site staff from having to travel to the site or mail cards from home. In addition, we have the ability to “trigger” a payment from another data source such as eCOA, ePRO and more.

We closed the webinar with a quick survey, and I also thought you’d be interested in this response:

• 86% of those who answered our closing survey said that they thought that “the clinical trial industry will be more likely to continue using telehealth and digital technology once the COVID-19 pandemic subsides.”

If you’re interested in checking out the full webinar replay, you can access it here. 

Q&A Session

There was also a robust Q&A session at the end of the webinar, and I’d like to take this opportunity to address some of the questions regarding new Greenphire solutions posed by attendees of the webinar.

ConneX Patient Direct

Q.  What type of vehicles are available for this service?

• There are different sizes of non-medical vehicles (vans, SUVs, sedans) as well as various medical vehicles – such as NEMT (Non-emergency medical transport).

Q.  What type of documentation is needed?

• If there is restricted movement in certain geographic location, the driver may need to be provided with official documentation from the site or other entity, to make sure that the medicine, equipment or personnel can get to and from the patient’s home.

Q.  Are there availability restrictions for or cause for concern on availability across the globe?

• To date, our network of global suppliers has not experienced any availability issues.  There is a recommended lead time of five days prior to delivery to help ensure availability.

Q.  Regarding the initiation phase, is the site contact access via telephone only with the Greenphire local agent, or can arrangements also be made electronically, via e.g. electronic request form?

• or via email, in addition to a call.

Q.  Could one driver do multiple drop-offs / deliveries in the same trip?

• Each delivery is required to be a separate request to ensure product control during delivery (right medicine/dose to right patient)

Q.  Is ConneX Patient Direct available for sites?

• At this time, ConneX Patient Direct is available for sponsors and CROs to implement for global studies. We would recommend a Site discuss with the Sponsor the ConneX offering, if it is not already being used, to see if the Sponsor is willing and interested in pursuing this service. Also, if you are in need of a local patient transportation service, Greenphire offers a ground transportation through our ClinCard Lyft integration.

Q.  Patient Direct: Are the drivers wearing face masks?

• Drivers are wearing them with increasing frequency, especially in areas where they are now required by local governments. If any Site needs to ensure that is also a part of the request (in regard to personnel traveling), it should just be noted in the request. I am not sure if a face mask is as much of a requirement for a medical package or delivery of IP (meds), but they can adopt it as needed.

ClinCard (Data Triggered Payments / Direct to Home Card Shipments)

Q.  What types of tech providers are you able to integrate with?

• We can integrate with any data provider that has an event-driven scenario (EDC, IRX, CTMS, ePRO, ECOA, etc.)

Q.  How quickly can we start using these services – for example, data driven payments, direct to patient card shipments?

• New ClinCard enhancements are available now. Features such as data-driven payments and direct-to-patient were recently announced in this press release and you can contact your Greenphire representative or request a demo now.

Q.  How do we mail cards directly to participants?

• This is a newly enhanced service available through ClinCard. Contact your Greenphire representative to get started.

Q.  What is the estimated time frame of the virtual cards?

• This is actively being pursued with Greenphire’s banking partners, and is expected to be available in the second half of 2020.  In the interim, ClinCards may be used today for patient reimbursements and we have also introduced direct-to-patient card shipments as well as data-driven payments (API integran for systems such as eCOA, ePRO, etc.)

Q.  With implementation of Greenphire’s new process recently implemented for direct remote access to payments, how is Greenphire handling circumstances when the research participant uses rideshare services (Uber, Lyft), for which the subject typically doesn’t receive a paper receipt?

• If patients utilize a rideshare service, these electronic receipts may be uploaded into the ClinCard portal by the study coordinator for retention and reimbursement.

Q.  How are you seeing Sponsors handling the need for additional payment requests/needs for patients when patient stipends need to be on informed consent and IRB/EC approval is needed?  This is not something that can happen quickly.

• Each scenario is different, but it is our understanding that the regulatory groups are expediting approvals, where possible.

Q.  In the event that a study visit requires a blood draw / nurse visit, does ClinCard have contracts with home health/ phlebotomists so that sponsor can be billed without going through a contract directly with these services?

• At this time we have relationships with travel providers that offer companion services, but this doesn’t include phlebotomists. It is an area that we are actively investigating.

eClinicalGPS

Q.  Study agreements usually include tasks sites are to submit invoices for payment (e.g., start-up). How does Greenphire interact with sites to ensure timely submission of invoices? Has this process changed with the pandemic?

• Greenphire enables sites to request payments within the eClinicalGPS portal. In addition, we can support payment execution that falls outside of the contracted terms if allowed by the sponsor/CRO (e.g., if a site requests a payment within the portal and the sponsor is willing to pay right away, we can generate an invoice and execute the payment at the time of request)