Based on a Cardiac Safety Research Consortium Think Tank held in October 2017 on “Detection, Assessment, and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development, this article discusses emerging cardio-oncology nuances and the latest regulatory thinking on ways to manage risks.
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What You'll LearnMost Recent Flipbooks
Lack of Training Compromises Trial Results, Expert Says
At its very core, a clinical trial is a measurement system; yet, the industry has not focused enough on training for everyone involved, from investigators all the way down to the patient.
Q&A: The Role of Expert Committees and the Regulatory Landscape
Dr. Seltzer, president and founder of ACI Clinical, and chief scientific officer of WCG Clinical, shared his insights on expert committees during a recent conversation with Bill Stedman.
Q&A with Dr. Nathaniel Katz
Dr. Katz, Chief Science Officer and the founder of Analgesic Solutions, shared his insights during a recent conversation with Mark Opler, MD, PhD, Chief Research Officer at WCG’s MedAvante-ProPhase.
Optimizing SUSAR distribution in a connected– but unharmonized–world
Steven Beales and Joe O’Rourke, vice president, business development talk through some of the difficulties Sponsors face when it comes to safety letter distribution, and how to overcome them.
Quality First: Using Data to Inform Site Selection in CNS
WCG MedAvante-ProPhase espouses a rather simple philosophy: minimize variability, generate cleaner data.
Don’t Do It Alone: To De-Risk Your Next Trial, Seek Outside Expertise
Due to evolving practices and increased regulatory attention on expert committee operations, sponsors are turning more to independent providers with experience in managing expert committees.
Protecting Sponsors Against Bias and Variability
Applied Clinical Trials recently spoke with Mark Opler, PhD, MPH, chief research officer of WCG, MedAvante-ProPhase, to learn why placebo response is the leading cause of failed trials.
Social Media Company Matches Sponsors with Patients to Advise on Trial Design Evidence Program
Q&A with CNS Expert, Dr. Andrew Cutler
Dr. Cutler, a member of WCG’s Scientific Leadership Team, shared his insights during a recent conversation with Mark Opler, MD, PhD, chief research officer at WCG-MedAvante-ProPhase.
Q&A with CNS Expert, Dr. Philip Scheltens
Philip Scheltens, MD, PhD, a member of WCG’s Scientific Leadership Team, shared his insights during a recent conversation with Christopher Randolph, PhD, ABPP-CN, chief scientific officer...
SNAPSI: Bridging the Gap Between Research and Clinical Care in Mental Health
In the field of mental health, there is a discrepancy between how research is conducted and how care is delivered. MedAvante-ProPhase, a WCG company, is collaborating with leaders in health care to...
Q&A with Dr. Sofija Jovic
Increasingly, sponsors are turning to experts who have “been there, done that” to help them develop protocols for their CNS trials. In this wide-ranging interview, Sofija Jovic, PhD, MBA, of WCG...
Q&A with CNS Expert, Dr. Leo Verhagen Metman
Leo Verhagen Metman, a member of WCG’s Scientific Leadership Team, shared his insights during a recent conversation...
Bridging the Measurement Gap Between Research and Clinical Care in Schizophrenia
The aim of this paper is to discuss how the measurement gap between research and clinical care in schizophrenia can be closed.
A Developmental History of the Positive and Negative Syndrome Scale (PANSS)
In this review article, the authors explore the history of the most influential schizophrenia research tools that have been created over the past several decades.
Q&A with CNS Expert, Dr. Scott J. Hunter
Scott J. Hunter, PhD, a member of WCG’s Scientific Leadership Team, shared his insights during a recent conversation with...
Q&A with CNS Expert, Dr. Michael Liebowitz