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

Join Todd Kays, PhD, Vial’s Vice President of Dermatology, as he discusses how the Vial Dermatology CRO delivers faster, higher quality trials for biotech sponsors.

I’m Todd Kays Vice President of Dermatology at Vial Health Technologies. I’d like to take the next few minutes to talk to you about Vial health technology, a technology enabled CRO and how our technology can be employed to conduct your dermatology trials faster and at a more favorable price point.

I’ve been involved in pharmaceutical development for over 25 years, providing clinical regulatory guidance. In the design management and reporting of clinical programs for NDAs, ANDAs and BLE submissions having held senior positions in pharma and contract research organizations, leading clinical teams manning all phases of clinical development from proof of concept through large global registration trials in most geographic regions.

After spending a number of years on the pharma side, identifying, evaluating, and partnering with large and small CROs to assist in the management of clinical programs, I joined Vial in December of 2023 based on their commitment to improve efficiency and reduce the cost of running clinical trials.

Prior to joining Vial, I transferred a trial from an underperforming CRO to Vial and was immediately impressed with how they were able to employ the technology that they have developed in-house to quickly transition the study over and complete enrollment of the important first phase of the trial.

Vial is fully committed to technology and eliminating a number of issues frequently encountered with other, more traditional CROs. Since its founding, Vial has raised over $100 million, has assembled a team of leading experts from Silicon Valley and partnering them with top talent from leading CROs and industry veterans to become a leading full service CRO able to deliver your dermatology trials more efficiently and at a reduced economic burden. 

Over the next few slides, I’d like to provide insight into how Vial utilizes our internally developed technology and an experienced clinical operations team to accomplish these goals.

Vial is focused on two main areas to help deliver dermatology trials in a more efficient and cost effective manner. As previously mentioned, Vial has developed a technology-based platform that focuses on greatly increasing the efficiency of study startup, conduct and reporting; reducing both the time to completion and cost of dermatology trials. 

Coupled with this technology, Vial is continuously building relationships with key investigators and advisors in the dermatology space. Leveraging their experience and guidance in how we employ our technology to deliver quality trials faster and at a lower cost than traditional CROs. 

The next slide shows several of the scientific advisors that are supporting Vial’s activities in the dermatology area. There are interviews with these thought leaders on our website in which they detail pain points they have experienced working with other CROs and why they’re excited to be working with Vial to address and overcome these challenges using Vial technology to help bring new treatment options to their patients, sooner.

In order to maximize the impact of the technology platform on your dermatology trials, Vial has strategically built an experienced clinical operations team, recruiting top talent from other CROs and pharma companies, as well as experienced members of the team that have worked on the trial side of things. This combined experience together with Vial’s technology platform allows us to realize our goal of delivering more efficient trials. 

Over the next few slides, I would like to provide a high level overview of our technology platforms. We can, of course, arrange detailed demonstrations of any portion of our technology with the tech team’s responsible for the design and implementation on your clinical.

I’ll start with our site startup app. The goal of which is to eliminate the slow startup process that can be delayed by reliance on email communication and exchange of documents, and a requirement for manual completion updating and signing documents. Vial’s goal has been to go with the COD-based approach. Wherein site regulatory packages reside on our platform that automatically notifies the investigative sites when documents are available. The cloud-based system provides detailed guidance for completion and submission of requisite documents, enabling seamless onboarding of sites for your clinical trial. In addition, we’re able to quickly download those documents for inclusion into the trial master file.

The next major component of Vial’s technology platform targets recruitment utilizing multiple channels to expedite identification and screening of prospective patients, resulting in a more rapid enrollment on your dermatology trial. Each study has a recruitment playbook deployed at the start of the study. Rather than waiting for a lag in enrollment before developing a mitigation plan, the teams will sit down with the client and come up with a playbook. Identifying potential challenges and establishing strategies to meet these challenges to ensure enrollment is completed within the projected timelines. 

In addition to the recruitment playbook, file has developed electronic medical record integrations compatible with [00:05:00] most of the leading EMRs to assist the site in review of their patient database. If a selected site utilizes one of these, EMRs, with which we are integrated and they’re willing to allow us to support them, we can put a legal agreement in place that allows access to their EMR and facilitates mining of their database to identify prospective patients. When potential participants are identified Vial’s call center, and recruitment consultants are able to facilitate the scheduling of pre-screening calls and screening visits. The end goal is to ease the burden on the sites and reduce the time required to expedite study enrollment.

The last piece of the Vial technology platform I wanted to highlight is our eClinical suite. It was completely designed and built by in-house engineers to efficiently deliver high quality data through accurate data capture and review. We currently have Vial eSource, and Vial EDC rolled out on trials, and the team is continuing to develop other add-ons such as ePRO and E-consent. 

Vial’s EDC platform includes built-in data query and management flows with end-to-end audit logs and user permissions. This intuitive and user-friendly system is encrypted at 21 CFR part 11, HIPAA, and GDR compliant. Your data is encrypted, secured, and protected.

One of the things I wanted to highlight is our ability to complete the initial build within four to six weeks, where the competition is typically closer to 12 to 16 weeks, in my experience. This enables us to quickly deploy our EDC on the project, ensuring that this is not a rate limiting site-to- site activation. 

As you can see when compared to other leading EDCs, we’re ticking all the boxes in terms of what our capabilities are. One of the things I wanted to highlight is our ability to complete the initial build within four to six weeks. Which is significantly faster than what I’ve seen with other more traditional CROs, which is typically 12 to 16 weeks to build out your database. This enables us to deploy our EDC on the project ensuring that this is not rate limiting in site activation at achieving the first patient in within the projected date. 

Another key point in our EDC is that we’re able to quickly make updates during the study. In the event of a protocol amendment, our goal is to have the EDC updated by the time the sites received IRB approval of the amended protocol, and to avoid any delay in patient enrollment.

With our in-house developed technology and experience team, we feel confident in our ability to run your project more efficiently and at a more favorable price point than other CROs. Our goal is to have fixed price agreements on our projects with no change orders unless there’s a significant change in scope or a major protocol amendment impacting study designer enrollment. To accomplish this Vial will work closely with you at the beginning of the project to set realistic expectations through the development of strategies to efficiently meet anticipated challenges and throughout the trial to overcome unanticipated challenges and bring your trial in on time and within budget.

I hope this brief overview of Vial, including our people and technology, has provided insight as to how we are able to accomplish the goal of delivering your dermatology trials faster and at a better price point. 

Please feel free to reach out if you would like to schedule a meeting for a more detailed demonstration of Vial’s technology platforms, and to discuss how Vial can partner with you to complete your dermatology trials faster and more efficiently. Thank you.