WEBINAR
Compliant Trial Master File Management & Migration in 2024
For small & mid-size Clinical teams, the TMF struggle is real. It’s 2024. There are better approaches to manage your trial master file. Learn leading industry best practices from Halloran Consulting Group, as well as a real-world case study from Elevar Therapeutics.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.