VIEW OUR UPCOMING VIRTUAL & IN-PERSON EVENTS
Case Study
How Akebia Therapeutics Built a Comprehensive Clinical Operations Ecosystem with Trial Interactive
About Akebia Therapeutics
Akebia Therapeutics is a biopharmaceutical company headquartered in Cambridge, Massachusetts, dedicated to bettering the lives of people affected by kidney disease. Since its founding in 2007, Akebia has grown into a commercial-stage company with two FDA-approved therapies, including Vafseo®, approved in 2024 for anemia due to chronic kidney disease.
As a lean organization that relies on a network of CRO and vendor partners to run its trials, Akebia places a premium on maintaining and clearly demonstrating sponsor oversight of its Trial Master File. Today, that oversight runs through a single, connected Trial Interactive platform spanning eTMF, eFeasibility, CTMS, LMS, and study start-up (SSU). The program is managed by Brandy Ward, Associate Director, Records Information Management and Head of TMF.
The Challenge
For years, Akebia relied on large third-party CROs to manage its Trial Master File. Over time, leadership recognized the challenges of maintaining consistent TMF quality and oversight across multiple partners.
Akebia worked with multiple CROs across its portfolio, each with its own TMF structure and naming conventions. As a result, content returned to Akebia wasn't always consistent or complete, a challenge compounded by an industry still straddling paper and electronic documentation.
Leadership drew a clear line: as sponsor and owner of its investigational product, TMF oversight was something Akebia needed to hold directly. But as a lean organization without a large internal document-processing team, it needed a true partner, not just software.
The Solution
Akebia ran a rigorous evaluation, building a detailed User Requirement Specification that mapped exactly how it needed its TMF to function. Trial Interactive emerged as the closest match, standing out for its price, flexibility, and ability to actively process documents on Akebia's behalf.
"Trial Interactive was the closest match to our needs, especially since it offers document processing and exceptional service post-implementation. We made the right choice."
– Brandy Ward, Akebia Therapeutics
The partnership proved itself during migration. Working closely with Trial Interactive's engineers, the Akebia team migrated roughly two million legacy documents, including several large pivotal studies, while mapping inconsistent naming conventions to the TMF Reference Model. What the team expected could take a year or more was substantially complete in three to six months.
Since then, Akebia has steadily expanded its footprint, adding eFeasibility, CTMS, LMS, and, most recently, the Study Start-Up module in late 2025.
"The SSU is a game changer," said Brandy Ward. "It met its intention by streamlining study start-up and essential document collection of the regulatory package for IP release.", says Brandy.
Beyond speeding up activation, SSU gives Akebia a structured way to exercise sponsor oversight of its CROs and vendors. An initial completeness review at the start of every study helps the team gauge timeliness and responsiveness from day one.
The Impact
- Inspection-ready, with minimal findings. Ahead of anticipated regulatory scrutiny of Vafseo®, Akebia ran a full mock inspection to pressure-test its TMF. "The TMF really did stand up…they treated it like the real thing: back room, front room, all the things, and there were very minimal findings. Even today, we're in really good shape."
- Faster, more connected site feasibility. eFeasibility replaced an ad hoc survey process almost overnight. Completed questionnaires now flow directly into the TMF, giving study teams instant access to feasibility data for faster, better-informed go/no-go decisions on sites and countries.
- Full visibility backed by hands-on support. Since rolling out CTMS, Akebia has been building centralized visibility into milestones, site performance, monitoring visits, and enrollment. This is supported by hands-on workshops and an ongoing monthly working session with its Trial Interactive Customer Success Manager.
- One home for training compliance. LMS gave Akebia a single home for study-specific training that had previously lived across multiple systems. Trial Interactive initially managed curriculum loading, user assignments, and sign-outs, with completed training flowing directly into the TMF. "We rely on Trial Interactive to do a lot of the heavy lifting for us during rollout and appreciate their support when we need it."
With eTMF, eFeasibility, CTMS, LMS, and SSU all on one platform, Akebia has replaced what could have been a patchwork of point solutions with a single connected ecosystem spanning study start-up through inspection readiness.