Miguel Willis headshot

Medical Devices Research in Latin America

Latin America comprises the region stretching from the southern border of the United States all the way south to Antarctica (see Figure 1*). Anyone who travels the territory will encounter a great range of idiosyncratic diversity, but also cultural and linguistic similarities. Spanish (spoken in most of the region’s countries) and Portuguese (especially prevalent in […]

Linda Behar-Horenstein headshot

A Mixed Method Approach to Assessing Good Clinical Practice Computerized Online Learning

PEER REVIEWED Clinical research translation requires a trained, well-prepared workforce of clinical research professionals who can effectively conduct critical testing in clinical trials.1 However, trials funded by industry and governmental sources have been criticized for inconsistencies in the design, execution, analysis, and reporting of clinical trial activity,2 even as development of new drugs, devices, and […]

Nadina Jose, MD headshot

Blind Spot in Clinical Trial Operations: Who is Watching?

Who is watching when clinical trial stakeholders—the sponsors, contract research organizations (CROs), and sites involved—are spread out doing simultaneous business on multiple trials across the globe? Who is watching to make sure that every individual clinical trial project is proceeding through its milestones with every possible issue and risk properly identified and responded to? The […]

Jan Peterson, Senior Regulatory Affairs Manager and Project Director, Emmes Corporation

Getting on Board with ICH GCP E6(R2): Impact on Study Quality and Operations

It took 20 years for the International Council for Harmonization’s (ICH’s) 1996 ICH E6(R1) Guideline for Good Clinical Practice (GCP) to reach the maturity needed for significant amendment. An earlier attempt by the U.S. Food and Drug Administration (FDA) in 1977 to institute similar provisions by regulation was basically unsuccessful, but lessons learned help develop […]

Madeleine Kennedy headshot

ICH in Focus: ICH E6(R2): What Does Third-Party Oversight Mean for Investigators, Sponsors, and CROs?

Over the past 20 years, the outsourcing of research and development (R&D) has become increasingly prevalent. The regulatory impact of this trend is reflected in the ICH Guideline E6(R2) from the International Council for Harmonization, in that several addenda have been made under the “Investigator” and “Sponsor” sections of the guideline. In this column, we […]