Webinar: Accelerating Oncology Clinical Trials with Vial, the CRO for Biotech

Join Rich McCormick, Vial’s Executive Vice President of Clinical Strategy, as he discusses how the Vial Oncology CRO delivers faster, higher quality trials for biotech sponsors. See full transcript below:

Hi, I’d like to take the next few minutes to talk to you about Vial. We are a tech-enabled CRO that is built for biotech from the ground up, powered by our own technology.

My name is Rich McCormick. I’m the Executive Vice President of Clinical Strategy and the head of our oncology therapeutic area here at Vial. I’ve spent the last 20 years delivering complex oncology projects for small to mid-size biotechs. I joined Vial in October of 2022 because I was looking for an opportunity to be part of something different. I was looking for a CRO that was fully committed to technology and eliminating the problems that had been facing research for several years.

Vial has raised over a hundred million and is currently assembling a team of leading experts from Silicon Valley and partnering them with top talent from the leading CROs. Our mission is to deliver full service global projects more efficiently and at a cheaper rate. Over the next few slides, I’m going tell you how we do that.

Vial is currently focused on two main areas to help us deliver in a more efficient manner. We are building relationships with key investigators in the oncology space to leverage their experience and obtain their guidance as we work through this complicated research space. In addition, we’ve developed our vial platform. It is currently deployed on multiple projects in multiple therapeutic areas, including oncology.

Here you’ll see several of our scientific advisors that are supporting our vial oncology CRO. On our website, you can find one-to-one interviews with each. Throughout those interviews, they detail the pain points that they’ve experienced working with other CROs. They’re interested and excited at the opportunity that Vial is going to do things differently. We have the technology to make our projects more efficient and we can run projects at a quicker rate. Therefore, these investigators and many others will have treatment options available for their patients sooner.

Vial is strategically building a very experienced clinical operations team. We have hired top talent from other CROs, biotechs, and also from the site level. This combined experience, along with our technology platform allows us to hit our mission of delivering more efficient trials. 

Over the next few slides, I’m going to walk through the technology at a pretty high level, but know that you can request a detailed demo of any portion of our technology, and we’ll be able to schedule time to walk you through and let you see the technology in action.

I’ll start with our startup app. Our goal is to eliminate the slow startup process that tends to be bogged down by large email chains manually updating and attaching documents, and honestly just things going lost when sites or CROs or clients have turnover. Our goal was to go with a cloud-based approach. 

Our regulatory packets are loaded into our platform. Sites receive an alert that they can start working on their documents. We receive updates, questions along the way via the cloud, and at the end we’re able to download those documents and move them into our TMF. Sites, in addition to clients, are very excited at the opportunity to eliminate those email chains. 

The next piece of our technology is related to patient recruitment. Our goal is to work across multiple channels proactively to try and reduce the amount of time that it’s going to take to hit our enrollment goals. All projects have a recruitment playbook that’s created at the start of the study, so we work closely with the clients, and our project teams to make sure that we have mitigations in place should enrollment fall behind. 

Another feature that we currently offer is EMR integration. If a site is willing to allow us access to their EMR, we currently have technology set up with 90% the EMRs to allow for that to happen. Once the legal agreement is in place with the site, our recruitment team is able to mine their database looking for patients that potentially could be enrolled on projects. This is critical in this era where site staff is really limited and stretched due to resourcing issues. We’re able to potentially find patients and even go as far as scheduling patients for a screening visit.

The last piece of our technology I wanted to highlight is our eClinical suite. We currently have eSource and our Vial EDC running on multiple studies. The team continues to develop other add-ons such as ePRO, eCOA, and even eConsent. Our EDC was built in-house by leading engineers. The system is completely compliant, so that’s 21 CFR part 11, HIPAA, and GDPR compliant.[00:05:00] 

When our EDC is compared to other leading EDCs, you’ll see here that we’re ticking all the boxes in terms of our capabilities. Two things I wanted to highlight are our ability to build the initial build, which really for us is only taking about four to six weeks to where competition is probably pushing 12 to 16 weeks. Our team is able to quickly deploy our EDC on the project to make sure that’s not rate limiting and hitting that milestone of first site activated and first patient in. 

Another key point to our internal EDC is that we are able to quickly make updates throughout the study. In oncology, especially early phase oncology, we’re going to be able to make those EDC updates rather quickly when a protocol amendment comes out. Our goal is to have the EDC updated before a site can even get IRB approval of the protocol amendment.

As a result of our technology, we feel confident in our ability to run your project more efficiently than other CROs can offer. As a result, we are looking to have fixed price agreements on our projects. That means no change orders, unless there’s major protocol, amendments or redesign.

What we want to do at the beginning of that study is to really closely collaborate with you to come up with very realistic expectations for how we see that study running from start to finish. Ideally, we lock in that contract and never touch it until the study’s over.

Thank you for taking time to listen to the overview today. Hopefully, I was able to highlight the benefits of working with Vial, our technology, our people, and our commitment from a contracting standpoint. We want to partner with biotechs that are looking to run projects faster and more efficiently. I look forward to hearing from you in the future and speaking to you in our next meeting.