FEATURED ARTICLES

• Risk-Based Study Training - Three Key Considerations

  In this article, learn about the three things you need to know to help you develop and deliver training that will help you mitigate study risks with an effective risk-based approach. 

• Overcoming Three Investigator Training Challenges For Clinical Trials

  The clinical trial landscape has changed in ways that we couldn't have imagined two years ago. It has also brought to light key investigator training challenges and helped our industry embrace technology-enabled innovation to help overcome those obstacles. In this blog, explore three training challenges that clinical study teams face, along with solutions provided by on-demand virtual training.

• Global CRO Embraces On-Demand Training And Achieves 100% Business Continuity During COVID-19

  Before the COVID-19 pandemic, a leading global CRO used on-demand investigator training services in addition a traditional, in-person training program until almost overnight, face-to-face training became impossible. This case study describes how this CRO embraced on-demand virtual training services and achieved 100% business continuity amid the COVID-19 pandemic.

• The Top Five Things You Need To Know About Hosting Virtual Investigator Training

  Before the COVID-19 pandemic, most investigator training was conducted in person. Today, many clinical trials are shifting to virtual training, and web-based on-demand training is quickly becoming the industry norm. Read this blog to learn about the five things you need to know to make your virtual investigator training more effective and engaging. 

• Why Web-Based Training Is The New Norm

  Over the past year, the clinical research industry has pivoted and learned to do things faster and more efficiently, including training. Virtual investigator training has helped to reduce costs, increase participation, and get sites enrolling faster. Check out the available article to learn why web-based training has become the new norm for clinical trials.

• Tailoring Site Support To Serve The Patient Experience

  Our subject matter expert, Sandy Smith, shares how WCG is assisting sites in overcoming challenges brought on by large numbers of layoffs and early retirements.

• Big Challenges For Small Sponsors: Competition In Oncology Research

  Trial growth has dramatically outpaced site capacity since 2015. At the same time, the number of new investigators participating in clinical trials has decreased by 48%. Those are just two reasons sponsors miss 80% of critical clinical trial milestones, but what are the implications for small biopharma companies?

• Do You Know Me?: The Subtle Distinction Between “Anonymous” And “De-Identified” Data In Clinical Research

  There is a subtle, but important distinction between research using anonymous datasets/biological samples and de-identified datasets/biological samples. For sponsors and clinical researchers, it is important to understand these terms and which status applies to data being collected or data that will be used in research, to ensure that the research is in compliance with the necessary regulations.

• Clinical Trials And Social Media: Friends Or Foes?

  For clinical trial participants, forming bonds with other participants online can increase the feeling of community, and enhance the sense of recognition for their contribution to the important science being conducted. These positive effects may improve study retention, but interactions between clinical trial participants can have potentially negative effects on the study as well.

• Making Clinical Research Inclusive: Strategies To Include The LGBTQIA+ Community In Research Trials

  Read about the importance of research in welcoming to and inclusive of people who are of all genders and sexual orientations. 

• Providing Research Participants With New Information – Is Re-Consent Always Necessary

  In an ever-changing clinical research landscape, it is critical that we are agile, flexible, and quick to adapt to change. But what if that change impacts currently enrolled study participants? How do we communicate changes to the study effectively and in line with regulatory guidance? This whitepaper provides tips and strategies for how to handle consent documentation with participants when new information becomes available.

• Parameters For IRB Review And Approval Of Electronic Consent Documents

  There are an increasing number of internet-based and electronic tools to assist in the conduct of research studies, but how do you ensure the format you’re delivering to patients clearly explains study changes and new procedures? Now, more than ever, there is a focused need on the design, conduct, and ethical challenges of trials involving eConsent platforms.

• Informed Consent And COVID-19: An IRB’s Perspective On Navigating The New Normal

  The pandemic has completed transformed the way patients, sites, sponsors, and CROs engage in clinical research and with each other. But what hasn’t changed is the number of questions surrounding informed consent and the participant’s ongoing willingness to participate in a trial. Learn the ways information is conveyed to study participants while adhering to regulations.

• Decentralized Clinical Trials – Best Practices In Moving Toward A Patient-Centric Research Model

  There has been a notable rise in the launch of “virtual” or “decentralized” clinical trials. COVID certainly plays a large part in this shift, but as does the need to move toward a more patient-centric research model. This paper examines the nature of decentralized clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining compliance.

• Improving Subject Selection And Endpoint Management In Alzheimer’s Trials

  The rapidly growing burden of Alzheimer’s disease worldwide, and the high attrition rate in trials of disease- modifying drugs for AD, call for better-designed clinical research, particularly in terms of selecting the right patients and making sure that endpoints are clear, transparent and well-supported.

• Expert Analysis Of Rater Discrepancies Allows Sponsor To Demonstrate Efficacy—Even With A Missing Endpoint

  A small neuroscience pharmaceutical company conducted a 28-day Phase II proof-of-concept clinical trial in 95 patients with a movement disorder. The company turned to WCG MedAvante-ProPhase for guidance and expertise, asking to re-analyze the primary endpoint data from all sources.

• Meeting Of The Minds: Exploring New And Old Worldviews On Depression

  In 2019, the treatment of depression changed forever, the result of decades of research by academia, industry and government agencies. What happened? The US FDA approved esketamine. It was a landmark moment: Approval of this new rapid-acting antidepressant formulated for intranasal use marked the beginning of a new era.

• Ensuring True Results And Bringing A New Therapy To Market

  Ensuring true results through accurate assessments, WCG MedAvante-ProPhase helped its client bring a post-partum depression therapy to market.

• Leading Pharma Enrolls 56% Faster With WCG Site Augmentation

  A leading sponsor initiated a time-critical and complex adult Staphylococcus vaccine study. Per the protocol design, this global study needed to address two key areas of support.

• Tailored, Dedicated Support Expedites COVID-19 Trial

  As COVID-19 spread around the world, the accompanying lockdowns and travel restrictions brought many challenges for clinical trials. At the same time, there was an urgent effort to develop and test vaccines and therapeutics. These endeavors required enrolling tens of thousands of trial participants as quickly as possible, creating a huge burden on clinical trial sites that were already trying to figure out how to continue work during a global health emergency.

• How WCG Statistics Collaborative Helped Breakthrough Therapy Obtain Regulatory Approval

  WCG Statistics Collaborative, Inc., provides guidance and statistical services to sponsors—including biotech firms with little or no in-house statistical capabilities. WCG Statistics Collaborative was involved in one of the most remarkable developments of this century: A first-of-its-kind therapy for a genetic condition.

• The Top 5 Benefits Of Outsourcing Expert Committee Management To An Independent Provider

  In this article you will see the top 5 benefits of utilizing an Independent Expert Committee.

• Don't Do It Alone: To De-Risk Your Next Trial, Seek Outside Expertise

  Whether the focus is endpoint adjudication, aggregate data monitoring or safety assessment, the clinical and device development industry clearly understands the value of establishing expert scientific committees to provide oversight on study data. What is less well understood, however, is the importance of independent expertise.

• A Successful DMC Requires A Productive, Early Organizational Meeting

  For a DMC, that first organizational meeting sets the stage for the DMC’s future data reviews. It should occur prior to recruitment and have a robust agenda. Explore this process in this blog post.

• FAQ’s About IBC Review Requirements

  WCG administers Institutional Biosafety Committees (IBCs) on behalf of over 400 institutions around the world. As partners working with a broad array of sponsors, CROs, and institutions WCG is frequently asked to help determine whether a clinical trial requires IBC review.