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/.
