Newsletter | May 13, 2020

05.13.20 -- COVID-19 Presents Unique Challenges For Oncology Trials

Featured Editorial
Industry Insights
COVID-19 FDA Response: Guidance Released For Conduct Of Ongoing Trials

Since the emergence of Coronavirus Disease 2019 (COVID-19) in the U.S., the FDA has released new guidance and information rapidly and continuously in a comprehensive response to the current pandemic. This blog discusses topics covered in the guidance and what they mean for sponsors, investigators, and institutional review boards (IRBs).

Five Frequently Asked Questions (And Answers) About eConsent During The COVID-19 Crisis

For the clinical research industry, COVID-19 poses both immediate and longer-term challenges. Sharing experiences is vital to our industry, now more than ever. Here I share the most frequently asked questions about eConsent technology, along with our responses, since it may be of value to your organization at this time.

Successful BYOD In Any Phase

The idea of bring your own device (BYOD) for use in clinical trials during any phase has historically been conceptualized as a futuristic alternative, rather than what it actually is — a viable option for many clinical trials. While there has typically been hesitance among sponsors and CROs to choose a BYOD model for their study, there is an increasing number of trials that have successfully deployed this model with great results.

Creating Patient-Centric Supply Chains With Just In Time Manufacturing

As sponsors adapt to the rapidly developing COVID-19 landscape, there is a need to ensure patients remain at the heart of supply chain operations. Learn how just in time manufacturing is one way sponsors can embrace patient-centricity, while effectively redesigning supply chains to respond to the additional challenges presented by the ongoing global pandemic.

Adaptive Design And Health Economic Analysis: Interview With Laura Flight

In this Q&A with Laura Flight, National Institute for Health Research (NIHR) doctoral fellow, we take a deep dive into the objectives of her recent paper A Review of Clinical Trials With an Adaptive Design and Health Economic Analysis. Learn more about the next steps for promoting better understanding in this area.

Dealing With the Unexpected: Surprisingly Fast Clinical Trial Enrollment

Faced with an unusual situation with patients rushing to enroll almost as soon as word of the study got out, this CRO quickly recognized the issue and ramped up staffing, right-sized other locations in the study, and collaborated effectively with all parties involved to deliver conclusive, positive results eight months ahead of time.

Experts From China Speak On Conducting Clinical Trials During The Pandemic

The first in our series of DIA DIRECT: COVID-19 Webinars. join us to hear from experts in China from across various healthcare product development functions on steps currently in place to ensure safety and efficacy of clinical trials continuing through this pandemic.


November 9 and 10, 2020 | San Diego, CA


Understanding Partner Options During The Uncertainty Of 2020

The vetting process for selecting outsourcing partners and service providers has been flipped on its head in 2020. That's OK, we're here to help. Clinical Leader’s new Sourcing Centers enable you to quickly browse the services and capabilities of a diverse group of suppliers who can help with your unique clinical research and trial needs.

Visit the Clinical Leader Sourcing Centers to ease your search.

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