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Your one-stop-shop for regulatory, clinical, and quality insights, from whitepapers to webinars to how to guides. 

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SharePoint vs RIM: When to migrate to a Compliant RIM System

Are you a regulatory leader trying to meet tight submission deadlines with distributed teams and multiple vendors responsible for various content? You are not alone. Many sponsors are...

5 June 2023
5 min read

How to Choose an EDMS for Regulatory Information Management

In pharma and biotech, managing regulatory information effectively is crucial for compliance and success. An Electronic Document Management System (EDMS) provides a powerful solution to...

1 June 2023
5 min read

Conducting a TMF Audit for Inspection Preparedness

Conducting a Trial Master File (TMF) audit is an important aspect of maintaining the quality and integrity of clinical trial data, as well as preparing for inspections. In this article, we...

29 May 2023
4 min read

Considerations for moving an electronic clinical trial

Moving an electronic Trial Master File (eTMF) can be a complex process that requires careful planning, coordination, and execution. A TMF is a collection of essential documents that...

22 May 2023
3 min read

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...

27 April 2023
26 min read

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...

18 April 2023
3 min read

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...

23 March 2023
1 min read

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...

1 March 2023
3 min read

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...

15 February 2023
1 min read

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...

7 February 2023
3 min read

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...

18 January 2023
2 min read

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...

15 December 2022
23 min read