Investigative Sites

Findings from a Tufts study examining the effects of COVID-19 on clinical trials.

Lessons from six months of conducting clinical trials during the COVID-19 pandemic

Hassan Kadhim, Director, Global Head of Clinical Trial Business Capabilities, Clinical Innovation & Industry Collaborations at Bristol Myers Squibb, discusses his perspectives on how the pandemic has shifted clinical innovation.

Recognizing pre-pandemic pain points, such as patient engagement and protocol development, could lead to post-pandemic trial success.

Exploring effective strategies for sponsors and CROs to ensure both their CRAs and sites are supported for high levels of site acceptance and streamlined remote monitoring.

The pandemic has thus far disproportionally impacted minority populations, and our ongoing failure to adequately represent all patients regardless of demographic background has never been more important to remedy than it is today, writes ACRP Workforce Innovation Officer Beth Harper.

Creative approaches are needed to address the clinical research workforce “talent wars”

Exploring how clinical research sites are redefining their business models to be more flexible, collaborative, and customized.

A case study of the Parkinson’s Progression Markers Initiative.

Site selection is one of the most important and at the same time challenging problems in clinical trials planning. Poor site selection may cause enrollment delays, resource waste on low or zero enrollment, and even potentially compromise trial results.

In this article, Moe Alsumidaie will discuss how my study teams manage monitoring reports and offer a tracking tool to assist sites with the process.

Examining the practicality of implementing CM techniques to drive trial oversight efficiency while saving on-site monitoring resources and costs.

The last time the ICH GCP Guideline was updated, the process of conducting a clinical trial, including risk assessment and monitoring, was a largely paper-based affair. Since then clinical trials have evolved substantially as they’ve become more complex, costly, and global in scope.

In this interview, Christa Polidori, Clinical Trial Disclosure Manager at Bristol-Myers Squibb and a leader for the TransCelerate Clinical Research Access and Information Exchange Initiative, will discuss the TransCelerate proposal in greater detail.

This data analysis takes a look at how much experience US clinical investigators have.

A model to identify the services and resources sites need to conduct high-quality clinical trials.

Estimates of active US investigators range from about 20,000 to almost 150,000.

Published data indicate the size and complexity of these Phase III studies has hardly changed over the last few years.

Hugo Stephenson MD examines his longing for the past with the advances of today's technology in this blog focused around sites.

Survey uncovers key best practices that sponsors, CROs, and sites should consider when faced with patient enrollment challenges.

Survey uncovers key best practices that sponsors, CROs, and sites should consider when faced with patient enrollment challenges.

This article discusses best practices and benefits of keeping a trial top of mind at global sites, and measuring some of the qualitative and quantitative impacts it can have on a trial.

Tanya Bridges and Donna Benson, from two non-affiliated study sites, discuss the burdens of using paper source forms, and their impact on resources and trial execution at study sites.

The nascent and fragmented global community of investigators is showing signs of scaling and maturing.

A survey from the Avoca Group examines issues related to quality of clinical trials and trial participation from the patients' view.

Meghan McKenzie, Associate Director and Sr. Clinical Program Lead at Genentech, elaborates on her experiences in the field of patient centricity from the perspective of the sponsor.

The FDA’s Office of Regional Affairs will look to implement their much-anticipated Program Alignment initiative, thus reorganizing the FDA field force in 2017. This new program will alter bioresearch monitoring of clinical research operations.

New study finds that the long-strained relationship between sites and institutional review boards may finally be improving.

A patient-centric approach to a Phase IV trial for an MS treatment resulted in lessons that can be applied to future therapeutic studies for this and other rare diseases.

Work burden and performance hurt by technology incompatibility.