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

Join Amy Del Medico, Vial’s Vice President of Ophthalmology, as she discusses how the Vial Ophthalmology CRO delivers faster, higher quality trials for biotech sponsors.

Hello, I’m Amy Del Medico. I am Vice President of Ophthalmology at Vial. Vial is a technology enabled CRO that’s been built from the ground up to service our biotechnology customers. Today, I’m gonna spend a few minutes telling you more about our CRO.

I have 20 years of industry experience and I come to Vial from IQVIA, where I spent 16 years. I have six years of ophthalmology experience, both in anterior segments and in retina clinical trials. I joined Vial because I was really excited about their innovative approach to clinical trial conduct.

Vial’s mission is to deliver fast and efficient clinical trials using Vial’s in-house technology.

Vial has raised over one hundred million dollars and is using part of these funds to continue to develop our clinical operations team. We partnered that team with top tech talent from the Silicon Valley.

We’re focusing on two key areas. Firstly, we’re building out our relationships with investigators across a number of different therapeutic areas. Secondly, we’re building and deploying our Vial technology platforms. These platforms are currently being used on multiple clinical studies at Vial, including studies in ophthalmology.

Our ophthalmology team has the backing of key opinion leaders with expertise, both in retina and in anterior segment clinical trials. Arshad, Paul and Raj will be well known to you, and they recognize the value of our innovative approach to conducting clinical trials. They are strong advocates of our CRO and they are on call to support us when needed.

We are strategically building our team of clinical operations professionals and pairing them with talent from the Silicon Valley.

This team develops and deploys our technology platforms for more efficient clinical study conduct. Today I’ll be providing an overview of those platforms, but we are always happy to provide demos if interested.

Our startup app has a goal to reduce site and clinical operations’ staff burden. It reduces the need for multiple email chains, managing attachments, and the potential loss of information. Sites are able to upload their documents directly into our startup app. They’re given reminders if there are documents that are missing, and then the Vial team is able to download these documents directly into our eTMF. We also recognize that working with vendors can sometimes be a bottleneck to startup. We’re currently working with our imaging vendor to integrate their platform.

Patient recruitment is proactively managed at Vial and study plans are put in place right at the beginning of the study in collaboration with our clients. We work proactively across multiple channels and are able to access 90% of EMRs. If sites are willing, they will sign a legal agreement with Vial and that will enable us to mine their databases for patients. Those patients are then handed to our call center where recruitment experts can handle pre-screening of patients to sites. Our goal is to minimize the burden on sites and to speed up patient recruitment. eSource and Vial EDC are being used on multiple clinical studies. ePRO, ECUR, and eConsent are also developed by our in-house team.

We’re also excited to launch our EBCVA worksheet. It has an intuitive user experience and user interface. It’s extremely important for keeping data clean when vision is a primary endpoint.

Our EDC is built in-house by leading engineers in collaboration with our clinical team. It’s managed by the team that built it and is fully compliant, for example, with HIPAA, and GDPR.

While we have features that many EDCs do not, there are also two important differences. Firstly, the initial build of a Vial EDC takes four to six weeks compared with the industry standard of 12 to 16 weeks. Secondly, we are able to quickly modify our EDC should the protocol require to be amended. It is our goal to have these modifications in place before sites have IRB approval for the Protocol amendment.

Using our technology, we’re able to be more efficient and therefore we can budget more competitively. We offer the opportunity for true partnering with fixed price budgeting and no change orders.

Our technology, our people, and our commitment to you is what sets Vial aside from other CROs. We’d appreciate the opportunity to work with you and thank you very much for your time.