Newsletter | March 19, 2025

03.19.25 -- Lessons Learned From Vivani Medical's Study Of GLP-1 Implant

SPONSOR

Webinar: Inspection Readiness for Decentralized Trials: Lessons from FDA Inspection of Pivotal DCT study

DCTs enhance accessibility by reducing participant burdens like travel and costs. Join us for an overview of a study using DCTs, focusing on the central and local Principal Investigator (PI) roles. Delve into preparations for inspections, including BIMO checklist references, PI interview guidelines, record-keeping requirements, and inspection process details such as agendas, oversight, and follow-up expectations. Click here to learn more.

TRIAL MANAGEMENT

Lessons Learned From Vivani Medical's Study Of GLP-1 Implant

Guest Column | A conversation with Vivani Medical's, Adam Mendelsohn, Ph.D.

Vivani Medical Cofounder and CEO Adam Mendelsohn, Ph.D. discusses the company’s first application of the NanoPortal, including its upsides for patient adherence, its optimized trial design,  and its reception among sites and patients.

Treating Deficiencies In Employee Training And Mentorship

Article | By Jenny Minigh, inSeption Group

Investing in employee training and development is not just beneficial for the employees. It also contributes significantly to the organization’s success and competitive advantage.

8 Critical Questions To Ask Your IRB

Article | BRANY

This article outlines eight essential questions to ask a potential IRB partner to assess their ability to help you navigate complex regulatory requirements while avoiding delays.

Clinical Trials, Meet Adaptive Design

Article | Veristat, Inc.

Learn about adaptive design (AD) trials that reduce clinical trial time and cost while enhancing patient safety by minimizing exposure to unsafe or ineffective treatments.

Must-Have Tools For Complex Clinical Trials: An Essential Guide

e-book | Medidata, a Dassault Systemes company

From adaptive designs to real-world data integration, explore expert insights on the technology investments necessary to meet evolving study demands.

Hazard Communications In Studies Involving Genetic Engineering

Article | By Scott Swindle, Advarra

How can effective hazard communication and SOPs from institutional biosafety committees enhance safety in clinical trials involving rDNA technologies and genetically modified biological agents?

Strategic Protocols And Partnerships In Clinical Trials

Article | 20/20 Onsite

By integrating patient feedback early in the design phase, trials can enhance recruitment and retention rates, ensuring both regulatory compliance and participant well-being.

SPONSOR

With the rise of more and more site networks, the power dynamic is shifting in clinical research. Join Clinical Leader Live on March 27th to learn how to build strong site-sponsor partnerships essential for trial success. Discover key responsibilities, hear real-world anecdotes, and find out what strategies work—and what don’t—in today’s evolving clinical research landscape. Registration is free thanks to the support of MRN, Advarra, and IQVIA.

DECENTRALIZED TRIALS

Social Media And A Site-Less Model Led This Trial To Pandemic-Era Success

Guest Column | A conversation with Geneoscopy's, Erica Barnell, MD, Ph.D.

Genescopy's Chief Science and Medical Officer Erica Barnell, MD, Ph.D. explains how social media recruiting and a site-less trial design helped the company's CRC-PREVENT Phase 3 trial succeed.

How Digital Devices Enable Safety Monitoring At Home

Video | By Clinical Leader Live

To ensure that patient voices are heard throughout the company, Sanofi has adopted a Patient Informed Research And Development model.

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