Newsletter | June 29, 2020

06.29.20 -- Inside Novo Nordisk's Patient Advisory Board Meetings

 
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Clinical Data Transparency And Public Disclosures: Overcoming Challenges With Prospective Writing

If a prospective approach is applied while preparing one document, it can support the creation of the other documents at a later stage. In this paper we will discuss the development of document connections while preparing material for internationally regulated disclosure and how to apply this information.

COVID-19 Regulatory Developments Impacting Technology Use In Clinical Trials

In light of the recent disruptions and challenges posed by COVID-19, there has been an increase in activity in promoting the use of technology in clinical trials. This blog reviews recent statements from the FDA (U.S. regulator), MHRA Inspectorate (U.K. regulator), various institutional review boards (IRBs), and ACRO (Association of Clinical Research Organizations) regarding the current situation.

Quality Metrics: How To Add Value And Meet The FDA's Expectations

Quality metrics have been widely used in the pharma industry to monitor quality systems, operational processes, and to promote continuous improvement initiatives in drug manufacturing. 

What Is ICH E6(R2)?

ICH E6(R2) is an addendum to the International Council for Harmonisation E6(R1) that provides good clinical practice (GCP) guidance. Regulatory bodies can issue major or critical findings for noncompliance; therefore, it is important to understand sponsors’ regulatory responsibilities in outsourced trials.

eRegulatory Binder Checklist: What Does The FDA Require?

eRegulatory binders help clinical sites organize and digitize the regulatory process. In this post, we take a brief look at what every FDA-regulated binder needs to have.

Navigating The Changing Clinical Trial Landscape

The only way to map a course to a better future is to understand the reality of the current landscape and what perpetuates the status quo. To do this, insight was gathered from those involved in clinical trials. The output of this research reveals the challenges and priorities that will shape the journey to the future of clinical research.

Clinical Supply Optimization: Building Trust To Ensure Patient Safety

With just one compound in the pipeline, a company was in trouble because its previous vendor made drug supply errors that compromised patient safety in Phase 2. Not only was the clinical team navigating the ethics investigation triggered by this violation of trust, the legal team was fending off lawsuits from investors.

Translating Clinical Trials Into Clinical Benefit

Co-editors Dr. Gary Kelloff and Dr. David Parkinson discuss topics raised in the translational science series of articles in the 2019 Global Forum and their implications in 2020 and beyond.

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