Get a Demo

1 min read

Kivo eTMF Now Available

Featured Image

Kivo is excited to announce the release of Kivo eTMF – an eTMF solution for emerging life science companies built on the Kivo platform. Kivo eTMF provides companies with a simple path to compliance for managing Trial Master Files with investigator sites and through virtual inspections.

etmf2

The Intersection of Clinical and Regulatory

Kivo's powerful regulatory platform and EDMS create the perfect foundation for managing clinical documentation. All of Kivo's existing tools work seamlessly in the eTMF product.

Start writing content like the protocol from one of Kivo's document templates. Then, simultaneously edit the document with colleagues and use Kivo's powerful workflow to Review and Approve the document. The approved document can automatically appear in your eTMF. When you submit that protocol to regulators, Kivo will track it across dossiers and provide you with a transparent view of everywhere the document is used, whether you are viewing the document in the DMS, in the eTMF, or in an eCTD. Kivo provides 360-degree visibility into all of your content.

Clinical Document Management that just makes sense 

Documents are stored using the eTMF reference model, making navigating and managing content intuitive. With Kivo, you can manage a single authoring and review process and link relevant documents between Regulatory and Clinical in the eTMF and have those links automatically update if a new version is approved. 

Your eTMF can be built with placeholders for expected documents, as well as the ability to assign those documents to users and set dates on when they are expected. 

Virtual Inspections Made Easy

investigator

Kivo was designed from the ground up to support virtual inspections. Inspectors use a secure account that enables them to view relevant approved documents and understand when missing content is expected.  Allow inspectors to the view content without downloading, printing or copying content out of the system. 

Easily Manage Studies, Sites, and More

Kivo eTMF makes it easy to manage studies, control sites, and investigators. Our flexible permissions model enables you to quickly add users, expose the appropriate content, and set permissions. Enable partners and Sites to upload their deliverables but limit their permissions on other content. 

Part-11 Compliant, EMA CTIS-ready

Kivo is cloud-based, with nothing to install for Sponsors, Sites, or Investigators. Provided pre-validated, Kivo can be implemented and up and running within days without extensive professional services or configuration. 

Request a demo to learn how Kivo can transform your organizational processes and accelerate your time to approval.

 

The 7 Best Quality Management Systems (QMS) For Life Sciences

In regulated industries like pharma and MedTech, a Quality Management System (QMS) needs to do a lot more than check off a compliance checklist.

13 June 2025
7 min read

How To Choose The Right CAPA Management Software For Life Sciences

Corrective and Preventive Action (CAPA) processes are essential for any life sciences organization aiming to maintain product quality and regulatory compliance.

12 June 2025
6 min read

Unique Challenges & Solutions For Combination Product Development

Combination products represent some of the most innovative therapies in life sciences, but they're also some of the most complex to develop, manufacture, and bring to market.

11 June 2025
7 min read

The 7 Best Quality Management Systems (QMS) For Life Sciences

In regulated industries like pharma and MedTech, a Quality Management System (QMS) needs to do a lot more than check off a compliance checklist.

13 June 2025
7 min read

How To Choose The Right CAPA Management Software For Life Sciences

Corrective and Preventive Action (CAPA) processes are essential for any life sciences organization aiming to maintain product quality and regulatory compliance.

12 June 2025
6 min read

Unique Challenges & Solutions For Combination Product Development

Combination products represent some of the most innovative therapies in life sciences, but they're also some of the most complex to develop, manufacture, and bring to market.

11 June 2025
7 min read