FEATURED ARTICLES

• Using An IRB’s Site Relationships To Relieve “Site Crunch” And Reduce Trial Pressures

  Read this blog post to learn how IRB’s – by utilizing their vast site relationships – can be a strategy and conduit for expediting site startup and relieving staffing burdens.

• Decentralized Clinical Trials: Best Practices In Moving Toward A 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 regulatory and Institutional Review Board (IRB) compliance.

• 90-Second Insight: Increasing Site Enrollment Capacity

  Sites are experiencing more pressures to recruit and retain patients than ever before, so how do sponsors support their research sites to create an enrollment plan that meets reality? Find out more by watching this 90-second insight video.

• Overcoming Enrollment Challenges In Overcrowded Research Landscape

  The way that we conduct clinical research has been changing since the onset of the pandemic, but a growing number of factors are hindering clinical trial sites from adequately enrolling. Discover  the top challenges encountered at sites today and what solutions you can deploy to overcome them. 

• Why Web-Based Investigator Training Is The New Norm For Clinical Trials

  Virtual investigator training has helped to reduce costs, increase participation, and get sites enrolling faster - check out this article to learn why web-based training has become the new norm for clinical trials.

• Total Safety Solutions For Small And Emerging Biopharma

  Pharmacovigilance is an end-to-end biopharma consideration whose efficacy and cost-effectiveness are enhanced by utilizing solutions tailored specifically to your organization and product candidate.

• Protecting Patients, Protecting Your Study: The Benefits Of A Well-Run Data Monitoring Committee

  Data Monitoring Committees (DMCs) provide independent, unbiased recommendations to sponsors, thus enhancing trial integrity. A well-run DMC protects patient safety and ensures data integrity. A poorly run one puts patients—and the trial itself—at risk. This article discusses what goes into a well-run DMC, and the consequences that can happen with a poorly run DMC.

• The Need For Independent Insight And The Role Of Data Monitoring And Endpoint Adjudication Committees

  Data Monitoring Committees (DMCs) and Endpoint Adjudication Committees (EACs) provide crucial validation on clinical data as additional support for regulatory submissions and commercial strategy. Partnering with outside experts can lead to better-defined data gathering, earlier risk signal detection and, ultimately, a value-enhanced, streamlined approach to leveraging the intelligence gathered from clinical trials.

• The Top 5 Benefits Of Outsourcing Data Monitoring Committee Management To An Independent Specialty Provider

  Today’s clinical development landscape is seeing more and more clinical trial designs that include a specialized oversight component on accumulating data that utilizes medical and/or statistical experts who operate within a committee structure according to charter-defined rules and procedures.

• De-Risking Clinical Trials Through Analytic Supported, On-Demand Medical And Statistical Expertise From The World’s Leading Clinical Trial Experts

  In this article, we discuss ways in which companies small and large can access the expertise of the world’s most respected medical and statistical experts to systematically enable timely risk detection, generate actionable insights into drug benefits and challenges, and enhance the safety/competitive profile of drugs as they move down the clinical trial pathway.

• 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

  In order to appropriately include all communities in clinical research, and to answer important research questions that impact all communities, explore the importance of making sure that research is 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.