In a more selective funding market, drug development teams are keeping their trial and regulatory records organized for investors, partners, and acquirers
PORTLAND, Ore. (November 06, 2026) - Kivo, the GxP-compliant document and process management platform for life sciences teams, today announced over 200 percent growth in biotech sponsors keeping their trial master files (TMFs) and regulatory assets on its platform, as more clinical-stage companies adopt its GxP-compliant solution to increase attractiveness to investors and acquirers. Sponsors now manage more than 3,000 drug programs in Kivo.
Kivo supports drug programs throughout their journey, from preclinical development through Phase 1, Phase 2, and Phase 3 clinical trials and ultimately toward regulatory approval, partnership, or acquisition. By bringing Regulatory, Clinical, and Quality operations together, Kivo helps ensure that the data and documents surrounding an asset are always ready for audits, inspections, and due diligence.
“Having more than 3,000 drug programs managed in Kivo represents a real shift in the industry,” said Toban Zolman, CEO of Kivo. “Guiding drugs through testing and approval is hard enough. The systems behind it shouldn’t make it harder. Our job is to remove the friction from GxP compliance so teams can focus on advancing great science and getting it closer to patients.”
Kivo Customers Landed $3 Billion in Investment in the Last Year
In today's investment climate, maintaining
diligence-ready documents creates a distinct advantage. Early-stage biotechs
are increasingly choosing to manage their assets in a validated, GxP-compliant
system from the start, rather than trying to store and share their pre-clinical
documents and data rooms from a file-sharing system.
In the last year alone, customers of Kivo
attracted more than $3 billion in investment capital, citing this as one of
their reasons for growth.
This reinforces the importance of keeping a
drug program ready throughout its lifecycle, as investment rounds, partnership
discussions, due diligence, and acquisition opportunities arise. Having the
underlying documents, data, and regulated processes organized and ready helps
teams move more quickly in these circumstances.
More Sponsors are Using Kivo to Take
Ownership of the TMF
More sponsors are also bringing their TMFs
into Kivo, either to manage active trials directly or to take custody of the
TMF from their CRO at study close. In addition to the need for inspection
readiness, the shift also reflects the impact of the ICH E6(R3) Good Clinical
Practice guideline, adopted by the FDA last year, which reinforces that
sponsors remain responsible for, and should maintain control of, their
essential trial records and data.
As a member of the CDISC Vendor Committee,
Kivo has also participated in the development of the new TMF Reference Model
standard. Kivo will host a webinar on the TMF Reference Model on Thursday,
November 12. Register here to attend: Unpacking TMF Standard Model V1.
See what's behind the momentum with a
self-guided tour of the Kivo platform.
About Kivo Kivo is building the next generation of
infrastructure for AI-driven drug development by partnering with life sciences
teams to simplify Regulatory, Clinical, and Quality operations through a
unified cloud platform. Designed for scaling pharmaceutical and biotech
organizations, Kivo supports RIM, eTMF, QMS, controlled document management,
submission assembly, eCTD lifecycle management, inspection readiness, SOP
management, and training management within a single seamless environment.
Unlike legacy vendors that rely on disconnected applications and lengthy
implementations, Kivo offers compliant, audit-ready, continuous validation
assurance – which avoids significant IT costs – both upfront and ongoing. With
Part 11 compliant e-signatures, process automation, and modern cloud
architecture, Kivo helps life sciences teams reduce operational friction across
the drug development lifecycle. For more information, visit: https://kivo.io/.
Media Contact
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