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Kivo Resources

Enhance clinical and regulatory document submission knowledge at your organization with industry-leading resources.

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WEBINAR

Establishing Quality Programs: A Practical Guide

Starting a quality management program from scratch can be daunting. Learn where to start, how to iterate over time without slowing down business operations, and how to select the right QMS in this on-demand webinar.

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CASE STUDY

Doubling Programs in 2 Years: Hyloris Case Study

Case Study: How Hyloris Pharmaceuticals scaled Regulatory, Clinical, and Quality Operations with Kivo GO. With over 28 submissions and 1 IND, Hyloris leveraged Kivo to double their pipeline in just 2 years.

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PRODUCT

Kivo GO Launch Demo: First Look

Relive the launch of Kivo GO, our flagship platform and document management system. CEO Toban Zolman walks through our new quality management system, active trial management, project management functionality, and more

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WEBINAR

IT Best Practices for Receiving eTMFs from CROs

Not all information technology professionals are aware of requirements specific to the electronic trial master file (eTMF) transfer. Ensure your trial data remains compliant during a transfer by listening to this on-demand session.

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ARTICLE

7 Questions to Ask your CRO about your TMF

Asking these 7 questions of your CRO to help uncover any gaps in their data management processes, and thus reduce your risk of data loss or inspection issues down the line.

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PRODUCT

Kivo Demo: TMF Transfer, Inspection and Storage

Learn how Kivo handles TMF transfers, inspections, and long-term data storage in this product demonstration by CEO Toban Zolman. Highlights include an automatic import tool, inspector access licenses, quarterly data integrity checks.

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WEBINAR

Inspection Preparedness After CRO Transfer

Hear Marion Mays, Clinical expert, and CEO Toban Zolman outline best practices for inspection preparedness, including preparing your team, your electronic systems, and your processes.

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WHITEPAPER

How to Conduct a TMF Audit

Conducting a TMF audit prior to your inspection day can reveal potential issues in advance, giving your team time to resolve them. This guide includes an example audit roadmap you can implement in your organization.

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WEBINAR

Managing the End-of-Study TMF Transfer

Do you know what happens to your TMF at the end-of-study? If you are working with a CRO, you may need to take possession of your trial data. Plan ahead for this transition with this webinar.

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WHITEPAPER

TMF Transfer Best Practices from CRO to Sponsor

Dive into regulations around TMF ownership and management, learn about the TMF Transfer process, and cover the 3 critical questions to answer when planning your transfer.

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WHITEPAPER

Building IND Regulatory Systems: Aligning People, Process, and Tools

Utilizing company resources wisely will help your team stay the course when facing tight deadlines and rigid submission criteria. Learn the framework in this free guide.

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PRODUCT DEMO

Kivo Q1 2023 Product Demo

Watch Kivo's quarterly product update to discover our latest features and innovations, including support for blinded and unblinded data and TMF import functionality.

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WHITEPAPER

Maximizing Resources throughout the eTMF Lifecycle

Discuss three key areas to consider when managing data in a resource-heavy environment to improve clinical efficiency.

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WEBINAR

Collaborating with your CRO for Study Compliance

Learn how to collaborate effectively with your CRO at each stage of the trial lifecycle, from defining your operating model, study oversight, document management, and end-of-study transfer.

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Whitepaper

3 Ways Organizations Fail TMF Virtual Inspections

Build eTMF inspection-readiness into your process and sail through your next inspection by following the best practices outlined in this free whitepaper.

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WHITEPAPER

How to Partner with your CRO for a Successful End-of-Study Transfer

The CRO <> Sponsor relationship is essential to clinical trial success. Learn how to create a cohesive partnership with your CRO for the entire trial lifecycle.

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WHITEPAPER

Navigating CTIS for EU Clinical Trials (Whitepaper)

As of January 31st 2022, CTIS is now mandatory for all clinical trials in Europe. Learn how to align your organization to the EMA's new submission system prior to your next European trial.

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WEBINAR

Navigating CTIS for EU Clinical Trials (Webinar)

Dive deeper into the CTIS format, now mandatory for all clinical trial submissions in Europe. Clinical expert Marion Mays and Toban Zolman outline the key changes and overall impact to sponsors in this webinar.

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WEBINAR

Compliance Meets Collaboration

SVP of Clinical, Marion Mays and CEO Toban Zolman discuss how to collaborate with inspectors, particularly during virtual inspections, to maximize your chances of a success inspection outcome.

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WEBINAR

eTMF Virtual Inspection Readiness

Watch Kivo's CEO, Toban Zolman and Clinical Expert, Marion Mays, take an in-depth look at virtual inspection trends and best practices in this on-demand webinar.

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WEBINAR

Managing IND Submissions Using Lean Principles

In this webinar, Director of Regulatory Theresa Pinnell and Kivo CEO Toban Zolman discuss how you can apply lean principles to your IND Submission processes, to keep your submission on time and complete.