Whitepaper: Building IND Regulatory Systems
This whitepaper covers these key topics:
Keeping critical operations in house and outsource commoditized tasks.
Simplifying and improving the hand-off processes to gain...
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...
Whitepaper: How to Partner with Your CRO for End-of-Study Transfer
When sponsors choose to outsource all or certain tasks of a clinical trial to a clinical research organization (CRO), the relationship becomes critical. Since CROs have their own...
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...
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 –...