The Role of Virtual Data Rooms in Drug & Device Development
In biotech, the term "virtual data room" often conjures images of fundraising diligence: a static folder of key documents used to satisfy investors or legal teams during a transaction. But...
Drug Development Trends for 2025 and Beyond
As we look ahead to 2025, there’s no doubt that we’re at a transformative moment in the life sciences industry. The pace of change is accelerating, driven by groundbreaking advancements in...
Kivo GO Feature Round Up: Clinical Updates
Rounding out our Feature Round Up series, this article will showcase some of the new clinical capabilities of our eTMF. To read more about the overall features of Kivo GO, our new Quality...
Kivo GO Feature Round Up: Regulatory Updates
Alongside the launch of our QMS, we’ve also made some big improvements to our regulatory management capabilities. In this article, we’ll outline what’s new and how those changes can...
Announcing Kivo for Quality: A QMS for Pharma and Med Device Teams
As discussed in our previous post, Kivo GO represents a huge step forward for collaboration across Regulatory, Clinical, and Quality functions. Obviously, this wouldn’t be possible without...
Kivo Feature Round Up
Now that the dust has settled from the official launch (including our company retreat and two back-to-back conferences - whew!) we’re finally able to put pen to paper on what makes Kivo GO...
Webinar: Best Practices for End of Study TMF Transfer
Do you have a plan for receiving your TMF from your CRO soon? Have you mapped out your strategy and how you will ensure you are maintaining the chain of custody for what is one of...
Best Practices for End of Study TMF Transfer
In the context of clinical trials, the end of study transfer is a crucial process that involves the transfer of various study-related documents, data, and materials from the sponsor or...
CTIS Part III: Adapting Your Organization to CTR/CTIS requirements
With CTIS now mandatory, it is imperative for sponsors planning a clinical trial submission in the EU to take all the necessary steps to maintain CTR compliance. Now is the time to make...
CTIS Part II: Document Management Best Practices for CTR Compliance
As highlighted in our previous blog, sponsors submitting trials in the EU will have to adopt a more integrated and collaborative workflow to meet the new submission requirements of EU...
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...