The Challenge
Like many sponsor teams, Elevar's work with multiple CROs left them with completed studies scattered across different systems and former partners. In their case, 19 studies were being stored in various locations, at a significant cost. And since studies must remain housed and available for inspection for 25 years, these costs were only going to grow.
Simultaneously, a PDUFA date was around the corner. To prepare for inspection, they began to examine their TMF data, discovering how difficult it was to track down and harmonize it all. And their existing systems did not have the ability to structure data according to the TMF Reference Model. Spearheaded by their IT leader, Matthew Webb, they began to explore solutions that would unite their data in a single system, while simultaneously reducing storage costs.
The Solution
Matt discovered Kivo while researching possible solutions, and was immediately impressed by Kivo’s nimble approach. “We are a SaaS-first organization,” says Matt, “Our group is too small to build up a bunch of servers, load operating systems, install applications, etc. That is just a non-starter for small organizations like us. Kivo understood the challenges of the emerging biotech space, and they showed that in spades from our first engagement.”
"Kivo understood the challenges of the emerging biotech space, and they showed that in spades from our first engagement."
To begin, Kivo worked with Elevar to plan the migrations, based on Kivo’s Part 11-compliant Document Migration Process. Once the process was fully defined, Kivo worked directly with Elevar’s partners to gather to study content, documents, files, records, metadata, and audit trails. The incoming data was mapped using Kivo’s proprietary Import Tool which, once configured, can import an entire study in just a matter of hours. Kivo then performed manual quality checks on the migrated documents, checking metadata, content, and audit trail accuracy. Kivo’s migration tool allowed the team to complete the migration of all 19 studies in 72 days (or 50 business days) from the time the data was received.
Kivo’s data import capabilities are unparalleled in the document management space. Says CEO Toban Zolman, “We invested significant resources to ensure getting data in and out of Kivo is exceedingly simple. We have a highly flexible database that lets us store everything - and I literally mean everything - and at any point in the future promote that data to metadata.”
The flexibility of Kivo’s model gave Elevar confidence that the newly migrated data could be accessed as needed by inspectors and other stakeholders. And should they need to move the data in the future, Kivo allows for that as well.
"If a customer is pushing data into or out of another system, they can do that quickly, seamlessly, and in a compliant manner. It further aligns us to the needs of our customers, and the work we completed with Elevar is living proof of that.” - Toban Zolman, CEO of Kivo
Zolman continues, “Unrestricted import/export is extremely novel in drug development, as is the fact that we have made our data models public. If a customer is pushing data into or out of another system, they can do that quickly, seamlessly, and in a compliant manner. It further aligns us to the needs of our customers, and the work we completed with Elevar is living proof of that.”
The Results
After gaining trial access to the Kivo platform, Matt and his team were surprised by how user-friendly Kivo was. “The ease of use is so refreshing. The complexity of traditional Part 11 Compliant systems is nonsensical. They were designed by and for large organizations. But Kivo makes it so easy.”
“The ease of use is so refreshing. The complexity of traditional Part 11 Compliant systems is nonsensical. They were designed by and for large organizations. But Kivo makes it so easy.”
Kivo also checked the necessary boxes from a technical and economical perspective. “Part 11 Compliant is table stakes of course. Having responsive design that works on both Macs and PCs, it’s economical and meets our price points. And it solved the challenges of virtual inspection. If an inspector comes to us and asks for data, I don’t have to go to a fireproof safe, pull out a USB, load it somewhere, and try to print a file. I can just grant an inspector access to the platform with controls and permissions already in place.”
Elevar has saved significantly on storage costs by consolidating into Kivo, and is currently using Kivo to manage multiple active trials.
