Peer-Reviewed Articles

Enrollment Cycle Times Can and Should Be Optimized

By Valerie Legagneur, Jonathan Peachey, Karen Correa, PhD, Gen Li, PhD

Case study shows that site activation is a key driver in determining patient enrollment cycle time, which can be minimized by identifying the "sweet spot" of sites to deploy for a clinical trial.

Mitigating Risk in Implementing Multi-Regional Trials in Multiple Sclerosis

By Marie Trad, MD, Cathy Vanbelle, Benjamin Moody, PhD, Amy Del Medico, Olja Tanjga, MD, Sam Khinda, Lynne Hughes, PhD

Examining the main challenges in designing and executing MS clinical trials and proposing mitigation strategies that may help alleviate these burdens.

Specialized Safety and Regulatory Needs for Small and Medium Biopharma Companies

By Chitra Lele, PhD

Outsourcing safety responsibilities to functional service providers (FSPs) during clinical trials and post-approval can help small-to-medium-sized enterprises balance their workload and maintain best-practice operations.

Comply with ICH E6 (R2)

The ICH E6 (R2) GCP Guideline became final in November 2016. As noted in the Guideline, since the original ICH E6 (R1) was released, clinical trials were performed in a largely paper-based process. E6 (R2) was developed to address the increased scale, complexity, and cost of clinical trials, and to include the advances that have been made in electronic data recording and reporting technologies, as well as the implementation of other approaches and, in fact, encourages the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
 

The articles can help ensure your GCP is up to par in the areas included in the ICH E6 (R2).
 

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Data Analysis

Non-Commercial Clinical Trial: An Underappreciated Source of Clinical Investigators

With the pharmaceutical industry looking for new investigators, a non-commercial clinical trial has become an under appreciated source.

Hospitals and Private Practice: US Clinical Trial Locations

A data analysis focusing on where US investigators conduct clinical trials.

US Clinical Investigator Experience

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

ACT TV

Events

Clinical Data Disclosure and Transparency

January 30 - 31, 2018
Philadelphia, Pennsylvania

EFGCP Annual Conference 2018

February 20 - 21, 2018
Hotel Renaissance, Brussels, Belgium

Clinical Trial Budgeting & Forecasting

February 22, 2018
Philadelphia, Pennsylvania

Blogs

Janssen Develops Analytical Vendor Oversight Model

By Moe Alsumidaie

Kristy Galante, Director Process and Infrastructure of External Alliances at Janssen, recently spoke about a novel vendor oversight model at ExL’s 8th Clinical Quality Oversight Forum, and will expand on the model in this interview.

TransCelerate Focuses on Improving Information Exchange Along the Entirety of the Patient’s Clinical Trial Journey

By Moe Alsumidaie

In this interview, Julie Dietrich will provide more information regarding this Clinical Research Access & Information Exchange Initiative and how it is expected to benefit patients and the industry.

TransCelerate: Perspectives for Addressing Patient-Clinical Trial Access Opportunities

By Moe Alsumidaie

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.

Noteworthy

Considering Sex as a Variable in Clinical Trials

By Nicole C. Woitowich, PhD, Cathleen Dohrn, PhD

A sex-bias that significantly impacts the advancement of women’s health exists in both preclinical and clinical research.

Sponsors Ask: Is Our Trial Plan Realistic? Toward a Data-Driven Feasibility Assessment

By Otis Johnson, PhD, Dominique Muszinski

Today, a data-driven approach to feasibility assessment can help ensure that a sponsor’s clinical research plan is designed to enroll the right patients, rely on the right investigators, and take place in the right countries for success.

Metabolomics: Improving the Route from Early Drug Discovery through Clinical Development

By John Ryals, PhD

Metabolomics can make a positive impact from early drug discovery through clinical development and beyond.

eBooks

Clinical Trials for Rare Diseases

This eBook will focus on advancing research, drug development, and trial management in rare diseases. Articles cover considerations from virtual trials and eCOA to the case for highly-skilled CRAs.

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