ABOUT WCG

WCG is the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. Comprised of two segments, Ethical Review and Clinical Trials Solutions (CTS), WCG enables biopharmaceutical companies, CROs, and institutions to advance the delivery of new treatments and therapies to patients, while maintaining the highest standards of human participant protection.

ETHICAL REVIEW

WCG IRB is rooted in an ongoing commitment to exceptional service, uncompromising integrity, unmatched industry expertise, and tireless innovation. We are proud to empower our clients in their mission to advancing health – then, now, and always.

Since 2000, WCG has provided personalized Institutional Biosafety Committee (IBC) services and streamlined processes to over 800 institutions comprising hundreds of actives sites around the world.

CLINICAL TRIAL SOLUTIONS

With WCG's Study Fast Start Solution, we can help you reduce your overall study start-up timelines by 35%, speed site enrollment by 30%, and cut site training costs by 50%.

WCG's flexible, on-demand solutions help sites reduce their study start-up timelines by 37%, boost financial results by 21%, and increase enrollment by 39%.

Site Augmentation services help ensure that study teams have the support they need to mitigate site staffing shortages and constraints. We work to understand your exact study, indication, molecule, or full therapeutic portfolio needs and then deploy a team of trained clinical research professionals to solve your capacity constraints.

WCG's Safety Services helps clients drive efficiencies beyond traditional approaches to achieve high-quality trusted data, exceeding regulatory requirements, and increasing the likelihood of approval.

WCG’s technology-enabled safety solution measurably improves the safety distribution process through leveraging global expertise and proprietary technology, while addressing the three main sources of sponsor frustration.

Sponsors and CROs continue to face extreme challenges and high risks in the design and execution of clinical trials in support of new CNS therapies. WCG has built a global cohort of expert clinicians, proprietary cognitive assessments, targeted interventions, and supporting technology to reduce the risk of trial failure for the most complex and subjective indications.

Cell & Gene Therapy from WCG will help your teams navigate this ever-changing regulatory space and set your trials up for success.

CONTACT INFORMATION

WCG

212 Carnegie Center

Princeton, NJ 08540

UNITED STATES

Phone: 609-945-0120

Contact: Lauren Ozmore

FEATURED ARTICLES

  • 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. 

  • 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.

  • 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.

  • 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. 

  • 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.

  • 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.

  • 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?

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.