FEATURED ARTICLES

• WCG Launches AIMS 4.1 Platform With Enhanced Endpoint Adjudication Capabilities To Facilitate Expert Review Of Clinical Trial Data

  WCG ACI Clinical, the leading specialty provider of independent endpoint adjudication and data monitoring committees for clinical trials, has launched the latest iteration of its proprietary AIMS® (Adjudication Information Management System) platform.

• Returning Study Results To Research Participants

  Studies show that most clinical trial participants want to know what was learned from their involvement. A growing number of sponsors are implementing plans to deliver plain language summaries to trial participants.  Read this white paper to learn about the current best practices for the content and preparation of plain language summaries, and the current guidance for how sponsors should work with Institutional Review Boards (IRBs) which have oversight of the clinical trials for which the summaries are provided.

• Virtual Clinical Trials Best Practices

  In recent years, alongside the increase in patient involvement in the design and conduct of research programs, there has been a notable increase in the idea of “virtual” or “decentralized” clinical trials.  This paper examines the nature of virtual clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance.

• Clinical Trial Recruitment Practices: The Evolution Of Ethical Considerations

  Recruitment practices for clinical trials have evolved significantly over the last few decades. Read this white paper to learn about the evolution of acceptable recruitment practices, and what IRB members typically look for when reviewing recruitment materials and practices.

• Best Practices In Site Feasibility Studies Can Set the Stage For A Healthy Trial

  Well-performed site feasibility can become the single most important factor in reducing costs and time spent in a clinical trial. With adoption of benchmarking and clinical trial tools, sponsors are able to know exactly how many sites they need in their trial, which makes site pre-identification essential for efficient study start-up.

• Preparing For Success: A Better Way To Manage The Feasibility Process

  Nearly 80% of clinical trials fail to meet their activation timelines. But why does the start-up process fail us this often? This question can be answered by implementing a Feasibility Maturity Model with six critical variables: data, process, technology, expertise, focus, and engagement.

• Finding New Solutions To A Current Unsustainable Model Of Clinical Trial Contracts & Budgets

  In a clinical trial, so much depends on contract execution and budget development; when they are not appropriately managed, progress across other study start up areas comes to a halt. Valuable time is waster, which costs dearly. By implementing three successful approaches to a new way of conducting contracting and budgeting, sponsors and CROs can see a 37% faster site contract execution timeline.

• Reducing Placebo Response & Measurement Error In Clinical Trials

  In this on-demand webcast, WCG experts Dr. Nathaniel Katz and Dr. Mark Opler illustrate why human error—including inaccurate symptom reporting—is driving placebo response and how proven, evidence-based interventions can be used to increase the overall chance of trial success. Hear their perspectives.

• How Calibrated Are Your Trial-Measurement Tools?

  Every person participating in a clinical trial creates inherent variability in the way they perform. A patient’s ability to report their symptoms accurately will impact trial data, as will a site staff’s verbal and non-verbal communication cues. But what if you could train people to reduce measurement error—and even decrease the placebo response? Read the article to find out how.

• WCG Introduces Velos eResearch eXpress

  The WIRB-Copernicus Group®’s (WCG™) Clinical Services Division introduces Velos eResearch eXpress™, an out-of-the-box, cloud-based solution that enables clinical research sites to centralize and manage their research activities on a single, automated technology platform.

• Independent Research Sites: Three Key Performance Metrics To Help You Increase Your Study Pipeline

  This article provides practical solutions for overcoming the biggest challenges independent clinical research sites face in data collection. Further, it highlights three key metrics that will help sites improve performance and drive success.

• To Mitigate Placebo Response, Test, Train And Control Expectations

  The placebo effect. It’s the curse of clinical trials across indications, but it’s a particularly thorny issue for pain researchers. In fact, along with the inability of many patients to accurately report symptoms, it may be the main challenge facing analgesic trials. Left unaddressed, these issues have contributed to the failure of many clinical trials.

• Identify And Rectify Data Problems Before It's Too Late

  In this blog post we discuss how central surveillance using statistical process control (SPC) and other analytical techniques-- combined with expert human analysis--maximizes assay and endpoint sensitivity, allowing sponsors to meet scientific and regulatory expectations for quality data in clinical trials.

• What You Don’t Know About Patient Recruitment Can Impede The Success Of Your Trial

  Recruitment is one of the things sites and sponsors just do. Everyone thinks they know what it means. But it’s so much more complicated than they imagine.

• Your 5 Questions About Enrollment Assistants Answered

  Enrollment assistants ease site burden and increase patient engagement. Following are answers to five common questions about the use of this on-the-ground recruitment support.

• Lessons Learned From 600+ Expert Committee Members

  Sponsors and CROs make increasing use of expert committees. Learn from members themselves on what it takes to have successful expert committee.

• WCG Acquires PharmaSeek, LLC

  The WIRB-Copernicus Group’s (WCG) Clinical Services Division announced the acquisition of PharmaSeek, LLC, including its wholly-owned subsidiaries PFS Clinical and PatientWise, leading providers of turn-key administrative, consulting, patient recruitment and training solutions for clinical research sites.

• Ask The IRB Experts

  Clinical research is complicated.  At WCG, we frequently get questions about the ethical conduct of research from clinical team members at biopharma companies and study sites. We know that for many of the questions we get, the person asking is not the only one struggling with that issue. Read the questions your peers are asking – and if you don’t see yours, submit one of your own.

• Not Like Everyone Else: Unique Challenges For Small And Emerging Biopharma Companies

  Small and emerging biopharma companies are conducting almost 50% of the clinical trials in the United States today. Unlike “big pharma”, small companies are usually working with lean teams, limited resources, and minimal infrastructure. In this paper, we explore some of the unique challenges for clinical development teams, and solutions that can reduce the pressure on teams and timelines.

• Compensating Participants In Clinical Research: Current Thinking

  New research on how people make decisions about research participation, and new approaches to the question of payments and compensation to participants, bring a new perspective; are payments to participants actually too low? This paper explores this question, and whether we should, in fact, worry much less about restricting compensation for research participants.