Kivo, a Portland, Oregon-based provider of GxP-compliant document and process management software for life sciences teams, has reported growth of more than 200 per cent in the number of biotech sponsors keeping their trial master files (TMFs) and regulatory assets on its platform. The company said sponsors now manage more than 3,000 drug programmes in its system.
Kivo linked the increase to clinical-stage companies seeking to keep trial and regulatory records organised for investors, partners and acquirers in what it described as a more selective funding market.
Support across the drug development lifecycle
According to the company, its platform supports drug programmes from preclinical development through Phase 1, Phase 2 and Phase 3 clinical trials, and on towards regulatory approval, partnership or acquisition. Kivo said it brings Regulatory, Clinical and Quality operations together so that the data and documents surrounding an asset are ready for audits, inspections and due diligence.
The cloud platform, aimed at scaling pharmaceutical and biotech organisations, covers RIM, eTMF, QMS, controlled document management, submission assembly, eCTD lifecycle management, SOP management and training management. It also includes Part 11 compliant e-signatures and process automation.
Toban Zolman, CEO of Kivo, said: “Having more than 3,000 drug programs managed in Kivo represents a real shift in the industry. 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.”
Customers report more than $3 billion in investment
Kivo said its customers attracted more than $3 billion in investment capital in the last year. The company argued that, in the current investment climate, maintaining diligence-ready documents gives drug developers a distinct advantage.
According to Kivo, early-stage biotechs are increasingly choosing to manage their assets in a validated, GxP-compliant system from the outset, rather than storing and sharing preclinical documents and data rooms through file-sharing systems. The company said having documents, data and regulated processes organised helps teams move more quickly when investment rounds, partnership discussions, due diligence and acquisition opportunities arise.
Sponsors take ownership of trial master files
The company said more sponsors are bringing their trial master files into Kivo, either to manage active trials directly or to take custody of the TMF from their contract research organisation (CRO) at study close.
Alongside the need for inspection readiness, Kivo attributed the shift to the International Council for Harmonisation (ICH) E6(R3) Good Clinical Practice guideline, which it said was adopted by the US Food and Drug Administration last year. According to the company, the guideline reinforces that sponsors remain responsible for, and should maintain control of, their essential trial records and data.
Life Sciences Global News has previously examined regulators’ expectations of technology in clinical development, including how the FDA and EMA regulate AI in drug development.
Involvement in the TMF Reference Model standard
Kivo is a member of the Vendor Committee of CDISC, the clinical data standards organisation, and said it has participated in the development of the new TMF Reference Model standard.
The company will host a webinar on the TMF Reference Model, titled Unpacking TMF Standard Model V1, on Thursday 12 November.
Frequently asked questions
How much has Kivo’s biotech sponsor base grown?
Kivo reported more than 200 per cent growth in biotech sponsors keeping their trial master files and regulatory assets on its platform. The company said sponsors now manage more than 3,000 drug programmes in Kivo.
How much investment did Kivo customers raise?
Kivo said its customers attracted more than $3 billion in investment capital in the last year.
Why are sponsors taking control of their trial master files?
Kivo said the shift reflects the need for inspection readiness and the impact of the ICH E6(R3) Good Clinical Practice guideline, which it said reinforces that sponsors remain responsible for, and should maintain control of, their essential trial records and data.
What does the Kivo platform cover?
Kivo is a cloud platform for Regulatory, Clinical and Quality operations, covering RIM, eTMF, QMS, controlled document management, submission assembly, eCTD lifecycle management, SOP management and training management.
When is Kivo’s TMF Reference Model webinar?
Kivo will host a webinar titled Unpacking TMF Standard Model V1 on Thursday 12 November.
