CTIS Blog Series Part I: 3 Ways to Prepare your Organization
One of the primary goals of the new Clinical Trial Regulation (CTR), which went into effect in January 2022 and will become mandatory as of January 31st, 2023, is to streamline the process...
Webinar: CTIS Technical and Process Implications for Sponsors of EU Clinical Trials
In this webinar, Kivo CEO Toban Zolman and SVP of Clinical, Marion Mays outline the implications of the upcoming requirement to leverage the CTIS portland for all clinical trials taking...
Webinar: Compliance Meets Collaboration - TMF Inspection Readiness
In this webinar, Kivo CEO Toban Zolman and SVP of Clinical Marian Mays discuss the differences between an in-person inspection and the more recent virtual or hybrid inspections....
Whitepaper: Understanding CTIS Guidelines & Process Implications
In January of 2023, CTIS will become the required portal for all new and ongoing clinical trials in the European Union.
This whitepaper will cover these key topics:
- What is the CTIS...
Inspection Readiness: Is Your Trial Documentation Complete?
The Trial Master File (TMF) conveys a study's chronology, and regulatory agencies worldwide view the TMF as a barometer of study health and compliance with Good Clinical Practice (GCP). For...
Kivo Feature Release Round up
Last week we announced our new eTMF product. While that launch has stole the headlines and attention, the Kivo team has been hard at work over the fast few months rolling out a significant...
Kivo eTMF Now Available
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...
Whitepaper: 3 Ways to Fail TMF Inspection
TMF inspections have changed quite a bit in recent years. At the basic level, collaboration, preparation, maintenance, and inspection of the TMF is no longer a centralized effort –...
Submit documents faster with Kivo’s ICH authoring packages
Emerging life science organizations often deal with authoring processes that are lengthy and complicated. Documents are difficult to format and maintain, and users often spend the bulk of...
Webinar: Managing IND Submissions Using Lean Principles
In this webinar, Kivo CEO Toban Zolman and Director of Regulatory Theresa Pinnell discuss how to apply Lean methodologies to the regulatory submission process, focusing on an IND submission...
Kivo Announces Funding to Accelerate Development
Kivo, Inc., a provider of regulatory software, today announced it has closed a $3 million seed round of funding. Kivo will use the investment to scale engineering and sales to meet the...
Kivo is Here!
Kivo enables regulatory teams to accelerate regulatory approvals through improved collaboration and management.
The transition from Gemstone to Kivo is complete. Reimagined from the...