Welcome to a new monthly newsletter from Kivo! We know you get lots of newsletters, so we want to ensure this is valuable for you! If you'd like to receive this newsletter in your inbox, subscribe via the form below.
What's inside:
- Biotech in Brief: Key news stories and regulatory updates
- Resources & Events: Helpful tips, upcoming events, podcasts, and more
- Kivo Feature of the Month: Auto-associate eCTD to docs
Let's dive in!
Biotech in Brief
Fickle Funding: VC investments in biopharma shrank 18.5% in 2023. Biopharma VCs invested $29.9B in 2023 compared to $36.7B in 2022. For emerging sponsors, getting your regulatory ducks in a row becomes essential as funding gets more competitive. Read the original report on Pitchbook.
Informed Information: FDA published draft guidance on how to present informed consent. The draft guidance also encourages sponsors, investigators, and IRBs to consider a variety of delivery methods for key information, such as written, oral, or media (illustrations or video) and electronic consent. Public comment is open until April 30th.
RWD OMG: EMA launches new HMA-EMA catalogue for Real World Data sources. The catalogue for RWD sources enhances and replaces the ENCePP Resources Database. The publication of the RWD catalogues brings the European medicines regulatory network closer to more data-driven regulation. Visit the catalogue here.
And a quick congrats to Kivo customer Artiva Therapeutics on their recent Fast Track Designation for AlloNK® in Lupus Nephritis 🎉
Resources & Events
🔥 March 20th: Join a panel discussion on TMF Management & Migration in 2024 hosted by Fierce Pharma and yours truly, featuring a case study from Kivo customer Elevar Therapeutics and insights from service provider Halloran Consulting Group. Watch the playback here.
TMF inspection in your future? Get a head start by conducting a TMF audit using this free audit checklist and uncover issues beforehand.
For a larger discussion of trends in document & process management for sponsors, check out this recent live conversation with Kivo CEO Toban Zolman on the Life Science Success Podcast.
Feature of the Month
Each month we highlight a Kivo GO feature that customers tell us they particularly appreciate. First one that came to mind is how we auto-associate documents from the eCTD to the correct doc in the DMS.
From the eCTD Viewer, you can click on "Association Report" to see all of the documents associated with your submission.
As you can see, many of the documents were automatically associated! You can override these associations manually, but automatic linking saves a ton of time.
And that's a wrap! To see more of Kivo's document management capabilities, check out our click-through demo. If your team or colleagues could benefit from a simple, cost-effective DMS solution, reach out to us at any time.
