Vial Streamlines Collaboration in Biotech Trials with Egnyte

"Egnyte’s eTMF is a fast, secure, CFR Part 11 compliant solution that’s perfect for the small to mid-sized biotechs we work with. It allows us to empower our clients with the best technology for their early-phase trials."

Andrew Brackin

Co-Founder • Vial

For a contract research organization (CRO), effective external collaboration depends on one thing: efficiency. The faster a CRO can prepare files, approve them, and send them to a sponsor, the better they’ll be able to deliver the low clinical trial costs and timelines their clients depend on.

Vial, a CRO serving small to mid-sized biotechs, understands that efficiency can be hard to come by. “If you look at some of the biggest CROs in the business, you’ll see that many of them still do everything on paper,” said Andrew Brackin, co-founder of Vial. “They use paper source documents, paper onboarding documents, paper everywhere. This really slows things down. So our goal was to build a technology-driven system that would bring down trial costs and timelines and yield the best possible outcomes for our clients.”

Vial found the foundation for this system in Egnyte. Since integrating Egnyte’s eTMF into its technology stack, the CRO has delivered faster, more cost-effective clinical trials, maintained full regulatory compliance, and stood out from the pack as a top-tier partner for biotech organizations.

Challenge: Build a System That Enables Efficient Collaboration

Brackin knew that delivering next-level efficiency to Vial’s clients would require a strong investment in technology – particularly in eTMF. As Vial developed their technology platform, they discovered a need for a centralized digital content repository to offer internal and external stakeholders easy and prompt access to content.

But as they evaluated eTMF vendors, they found most were designed for large biotechs running late-phase trials. “We mostly run early-phase trials for small to mid-sized biotechs, and for trials like these, you need a system that’s easy to use, flexible, and that keeps costs and timelines in control,” said Brackin. “But the solutions we were finding were big and clunky and didn’t meet our needs.”

The team started considering building an in-house eTMF system. “We wanted to build a tech platform that’s just as good as any enterprise tool,” said Brackin. “But the idea of building a native eTMF that could compete with the market leaders in ease of use, security, and compliance was daunting. That’s when we discovered Egnyte.”

Solution: Integrate with Egnyte to Unlock Collaboration Efficiencies

The team evaluated Egnyte's eTMF and found it easy to use due to its cloud-based infrastructure, allowing for real-time file sharing and centralized content lifecycle management. After verifying Egnyte's compliance with CFR part 11 and its support for the TMF Reference Model, Vial integrated it into their tech stack and used it as a central collaboration point for key content.

Luke Bogus, Product Manager at Vial, led the implementation and found the process much faster and easier than similar platforms he’d previously used or evaluated. “Egnyte has a great API, and it was really easy to integrate their eTMF with our native products. Our team has found the platform intuitive and easy to use, which was not the case with other systems,” Bogus explained. “Egnyte also expedited our onboarding and implementation by two weeks so we could get up and running in time for an upcoming trial. All of this made us much more productive.”

Once the team started using Egnyte for content collaboration, the positive impact on their workflows was immediately apparent. The eTMF drove efficient collaboration in two key areas:

• Document approval
  Before a CRO can approve a clinical trial document, they must run through extensive QC processes. “Each time I received a document from a site, I would have to cross-reference it with another document, make sure all the content was correct, sign both documents and store them. This involved tons of time-consuming manual processes and documents that were easy to lose track of,” said Bogus. “Egnyte’s eTMF unified these workflows into one cloud-based environment. When we receive a document, we can automatically assign the correct user. The user can go straight to the document, complete their tasks, and sign off, all within Egnyte and in an auditable, visible way.”
• Storing communications
  Regulations required Vial to store all sponsor-site communications within their eTMF – a much easier process thanks to Egnyte’s seamless integration with Gmail. “With other eTMF products, each time I needed to store an email thread, I would have to download the thread from Gmail as a PDF, rename the file, manually upload it into the eTMF, and do the QC work,” said Bogus. “With Egnyte’s Gmail integration, we can link threads directly into the eTMF and vice-versa.”

"Egnyte’s eTMF unified these workflows into one cloud-based environment. When we receive a document, we can automatically assign the correct user. The user can go straight to the document, complete their tasks, and sign off, all within Egnyte and in an auditable, visible way."

Luke Bogus

Product Manager • Vial

Benefits: Fast, Cost-Effective, and Compliant Services for Sponsors

The efficiencies Vial has unlocked with Egnyte have yielded unprecedented time savings. “We’re able to manage each document much more efficiently, and when you multiply those efficiencies by the thousands of documents in a typical trial, it adds up,” Bogus explained. “We now move 30% faster on key tasks like storing documents, quality checks, reporting, and many others.”

Unifying their content management into Egnyte’s eTMF improved efficiency and created a clear and simple audit trail. “When using paper, it was hard to see who had viewed, modified, or exchanged documents, and when,” said Bogus. “All of that is now saved automatically in Egnyte. Combined with Egnyte’s full CFR-Part 11 compliance, this allows us to assure our clients that the content they receive from us has been handled in a fully compliant manner.”

Egnyte has empowered Vial to fulfill their fundamental obligation as a partner in biotech trials: to submit high-quality, ALCOA-plus-adhering, auditable content to their clients faster than ever. And with time savings come reductions in trial costs: “The total cost of ownership of Egnyte is one of the biggest benefits,” said Brackin. “Time is money in clinical research, and by accelerating our processes, digital technology like this enables us to reduce trial costs by around 50% – certainly a great return on investment.”

Looking ahead, the Vial team sees a long and fruitful partnership with Egnyte. “Our plan now is to get all of our trials into Egnyte,” said Brackin. “It’s a really great, secure, CFR Part 11 compliant solution that’s perfect for the small to mid-sized biotechs we work with. It allows us to empower our clients with the best technology for their early-phase trials.”