Are you a sponsor looking to make your study training more efficient, engaging, and cost-effective? Read our case study about how we have been helping one of our clients do this since 2018.

The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – check out our latest eBook on virtual study training to learn more today.

The critical difference between these two study designs is whether the intervention occurs because it is a component of participation in a research protocol, or because a clinical decision was made that the intervention was the appropriate treatment option. In this paper, we will address how sponsors/investigators can design research protocols that clearly indicate whether the clinical intervention is occurring within, or outside of the context of the research, and why this distinction is critical in ensuring regulatory compliance.

During the last year, Toolbox Medical, Inc. has been exceptionally busy, helping clients develop COVID-19-related products. In fact, they launched at least six studies in January 2021 alone. As Toolbox’s client base and workload grows, it relies heavily on its long-time IRB partner, WCG IRB.

Paying participants for the essential role that they play in clinical trials is important, but the amount given, and how it is paid, require careful consideration. But how can sponsors strike the right balance between compensating research participants to achieve benefits, while minimizing the potential for the payments to have an undue influence on their behavior?

The growing gene therapy market presents a multitude of challenges that sponsors, CROs, institutions and their sites must consider when running these trials. To meet these challenges, all stakeholders need to understand the important roles of not only the IRB, but also the IBC—Institutional Biosafety Committee—in facilitating a safe and effective study. In this article, we share the four biggest takeaways for drug developers in this booming space.

The content of training required to conduct clinical trials can overlap significantly from study to study. A common frustration for clinical site teams is the required completion of training for a new trial that is identical, or nearly identical, to training they previously completed for another project. Check out this case study to learn more on how WCG Trifecta helped eliminate redundant training through a clinical qualification management system.

As on-demand clinical trial training and virtual investigator meetings become more common, Sponsors, CROs, and Sites have many questions on the subject. Here are answers to some of the most common questions we receive on virtual clinical trial training.

The use of virtual training through web-based meetings existed long before COVID-19, but the pandemic made web-based on-demand training the new norm. Check out this article to learn more on how virtual site training can help increase site participation, reduce redundancies, and cut costs.

Your sites are likely feeling pressure as they never have before due to COVID-19. Between mass staffing shortages, mounting financial constraints, and ever-increasing new study or trial registrations—the clinical research industry is experiencing a perfect storm. See how you can help your sites overcome this new reality.

New investigator participation is down 48% over the last 5 years while new trial registrations are up 44. Clinical trial growth is simply outpacing site capacity—and it's being exacerbated by the effects of COVID-19. Watching this :90 Insight video to learn more about how you can increase your sites’ bandwidth today.

Now more than ever, clinical trial sites are facing increased internal and external pressure due to COVID-19—an issue we are calling “Site Crunch.” With mass staffing shortages and average site revenue down 38% in 2020, how will this impact your sites' ability to conduct trials going forward?

Even during normal times, the usual approach to safety reporting places a heavy burden on sites. Sponsors inundate them with safety notifications, many of which are unnecessary. As a result, sites become overwhelmed and miss critical patient safety information, which become lost in a mountain of paperwork that includes unnecessary notices. Moreover, this practice is contrary to health authority and country-level rules and regulations. This article outlines many ways sponsors and sites can align for a more streamlined and efficient safety letter distribution process.

Institutions play an integral role in translating “bench” research into practical applications that advance human health. To do this, researchers need strong research infrastructure to function as an “engine” that can accelerate discoveries. Over the recent months since COVID-19 hit, we’ve gleaned some insights and best practices in working with institutions.

The struggle to fight disease has always been about the patient. It always will be. And in this era of COVID-19, suddenly everyone is getting a glimpse into the urgency that patients feel. The general public can now see what people with serious and life-threatening disorders have long known: that time is of the essence. We want to stop a disease quickly, before it harms. Yet the question still remains: How can we get the right medicines and care with the speed we need while keeping patients safe during a global crisis?

The COVID-19 pandemic has caused unprecedented disruptions to our lives and to clinical research, with many clinical trials pausing new enrollment on studies. By being proactive and engaging with your existing patients during this time, your site can prepare for when clinical trials begin screening patients again. Here are four actions your site can take to ensure recruitment readiness during the pandemic.

The COVID-19 pandemic suddenly changed the clinical trials environment with impacts on all stakeholders that at first are negative, but could be positive in the long term. There is talk of transformation that could last well beyond the crisis. Optimistic views include speculation that there could be wider adoption of practices that have languished in concept or startup mode until now. In this transformative time, independent sites may be faster to pivot to new ways of operating.

WIRB-Copernicus IRB has received questions from several research sponsors about the appropriate process for making changes to clinical studies in response to the current COVID-19 epidemic.

As the science behind therapeutic interventions has deepened and grown, the clinical trial designs through which those interventions can be best tested have evolved as well. To study therapies directed against specific abnormalities, in cancer for example, it may make sense to include anyone with the target abnormality in the trial population, regardless of the location of their cancer.

WCG, the world's leading provider of solutions that measurably improve the quality and efficiency of clinical trials, today announced that The Michael J. Fox Foundation for Parkinson’s Research (MJFF) is introducing a redesigned version of its Fox Trial Finder clinical study matching tool powered by WCG CenterWatch iConnect.

Infectious Disease "challenge" studies are ones in which healthy participants are intentionally infected with pathogens in order to investigate the cause, prevention, and treatment of infectious diseases- but are they ethical? These studies, while useful, pose ethical concerns, and numerous criteria must be met for an infectious challenge to be ethically permissible.

Patients and their advocates can--and do!--use their collective voice to promote transformation through the legislative process. It can be a protracted process, but it can yield dramatic changes in policy that speed drug development and enhance safety.

Meaningful collaboration between patients, sites, and sponsors can yield improved clinical trial outcomes. As part of that important collaboration, we see that effective patient input has the potential to increase patient participation rates in clinical trials. Incorporating patient insights into clinical trial design and execution is the first step.

Patient voice isn’t an accessory; it’s foundational. Patients are key to clinical trials, and relegating them to mere “subjects” diminishes their value. Including the patient voice in study design and development can make an enormous difference in recruitment, enrollment, and retention. Doing so also pleases regulators, who are increasingly putting a premium on patient-focused drug development. It doesn’t have to be difficult, but getting it wrong--or not doing it at all--can undermine a trial.

WCG (WIRB-Copernicus Group), the world's leading provider of solutions that measurably improve the quality and efficiency of clinical trials, today announced its acquisition of Statistics Collaborative, Inc. Based in Washington, DC, Statistics Collaborative has almost 30 years’ experience providing highly specialized biostatistical consulting services to developers of new drugs and biologics.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

Approximately 20% of cancer clinical trials will never be completed, because they fail to enroll enough participants to be able to answer the research question. Read this white paper to learn the impact that participant payments may play on clinical trial recruitment.

The WIRB-Copernicus Group® (WCG™) is pleased to announce the addition of several prominent executives to its Site Division and the expansion of its Global Research Network™ (GRN) of investigative sites. WCG is the leader in supporting clinical research sites in their critically important work of conducting clinical trials.

The WIRB-Copernicus Group®’s (WCG™) Clinical Services Division announces the acquisition of Analgesic Solutions, LLC, the global leader in the development of new pain medications and in the support of clinical trials in which pain is an indicator of an underlying condition.

How can researchers identify participants’ overall level of suggestibility and then focus on the minimization of this characteristic to solve the issue of suggestibility in clinical trial?

Genetic testing is making it easier to identify patients for clinical trials. However, genetic testing in the context of clinical trials raises raise important ethical issues, including ones related to informed consent and disclosure of results. Genetic counselors can play a crucial role in helping sponsors address these operational and ethical issues, making trials more efficient, more patient-centered and, ultimately, more successful.

Overall, the landscape of patient recruitment and enrollment have become highly specialized and data-driven. They demand a specialized, data-driven approach that nurtures potential participants and delivers bottom-line results, quickly and within budget. Read how an Enrollment Assistant can reduce the site’s workload, accelerate enrollment and make the entire recruitment process more efficient.

The WIRB-Copernicus Group’s (WCG) Clinical Services Division has acquired the Velos eResearch business line. Velos is a leading provider of clinical trial management solutions (CTMS) that increase the productivity and efficiency of clinical research.

IN 2018 there were many changes, trends, regulations and priorities that shaped the direction of the clinical research and drug development fields. In this paper, WCG experts share what they anticipate in 2019, and what everyone should be prepared for as we approach another year of change.

Insights into the impact that the shutdown will have on the FDA and on the review of investigational products, including those reviews which were already in process at the time of the shutdown. 

As you evaluate clinical trial enrollment acceleration strategies, be sure to understand the root causes of slow enrollment and the reasons why traditional acceleration programs do not work. 

Study start-up delays have perplexed the best minds in the clinical trials industry for decades. Discover how advanced analytics and an intense focus on the four problem areas can help.

A breakdown of regulatory guidances and a clear picture of what the IRB needs to see.

Solutions to manage an overwhelming response to a media campaign.

Five characteristics to look for when finding the best-fit site for your study.

WCG™ (WIRB-Copernicus Group®) Clinical Services Division, the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research, recently announced the opening of the company’s new office in Tokyo, Japan.

WCG™ (WIRB-Copernicus Group®) Clinical Services Division, the world's leading provider of solutions that measurably improve the quality and efficiency of clinical research, today announced its acquisition of ACI Clinical, the top provider of Endpoint Adjudication and Data Monitoring Safety Committees.

What are the things that high-performing clinical research sites do that make sponsors return to them again and again?

How to bring efficiency back to the  review process and to ensure that investigators are spending their time where it matters most, with the study participants.

Although there are clear benefits with the first pill to include a digital sensor that tracks if and when it has been ingested brings, there are also questions regarding  patient privacy and choice.

Improving outcomes in clinical trials and reducing the trend toward high placebo response across different therapeutic areas requires the involvement of multiple stakeholders.

Six things that high-performing clinical research sites do that make sponsors return to them again and again.

In this paper, some of our thought-leaders provide their insights on what they are watching for and what they anticipate in 2018 in clinical trial technology, regulatory changes, and scientific developments.

Before 2020, most study training provided to clinical research sites relied heavily on monitors doing training at initiation visits, and web-based on-demand training was a novel concept used by only a few forward-thinking sponsors. When the COVID-19 pandemic hit, web-based on-demand training became a must-have, not a nice-to-have. Don't have time to watch the full Virtual Site Training webinar? Check out our 10-minute webinar highlight reel to learn more about the differences between in-person and on-demand training, and the benefits of virtual training.

Before 2020, most study training provided to clinical research sites relied heavily on monitors doing training at initiation visits, and web-based on-demand training was a novel concept used by only a few forward-thinking sponsors. When the COVID-19 pandemic hit, web-based on-demand training became a must-have, not a nice-to-have. In this on-demand webinar, learn how combining on-demand training with web-based meetings has become the new training best practice for clinical trials.

Can patients be trained to report their symptoms more accurately? With proper design and implementation, you can structure clinical trials, such as pain management studies, so that patients learn how to better report their symptoms. During COVID-19 sponsors have had the opportunity to examine ways to introduce new technologies, such as telehealth, to clinical trial operations and to use more science-based tools for evaluating the performance of clinical trials.

At 51, Jeffrey Borghoff was diagnosed with Alzheimer’s disease. What would devastate many people turned Borghoff into an advocate. The former software architect and developer is now a national spokesperson for the Alzheimer's Association and board member of the Greater New Jersey chapter. In this podcast, he talks about how the diagnosis forced him to reprioritize his life. “I've been pretty successful at that. I've been leading a very purposeful, engaging, joyful life.” With his care partner—his wife, Kimberly—he travels around the country making the case for research funding—and for clinical trial participation.

Remote assessments have become a necessity across CNS trials, but some areas are more complicated than others. Schizophrenia provides one such example; the risk of variability is high, and sponsors are concerned. PANSS—the gold standard rating scale for schizophrenia primary outcomes—is based largely on face-to-face interviews; it wasn’t developed for remote assessments. Is it still usable? The answer is addressed in this podcast.

The switch to remote methodologies as a response to COVID-19 has had a profound effect on the conduct of psychiatric disorder trials. Supporting these remote trials requires new tools, sophisticated technology and, most important, deep scientific and clinical expertise. COVID-19 has forced everyone involved in psychiatric trials to reconsider not only the tools and technology they use, but the entire patient encounter.

Now, more than ever, the partnership between sites and sponsors is essential, as we all navigate the changing site environment and workflows necessitated by COVID-19. With its acclaimed “SMILE” (Sanofi Making Investigator Lives Easier) program, Sanofi led the industry in building up those critical partnerships in 2019.

The problem of the spread of scientific misinformation is very real. We’ve probably all seen stories on social media about COVID-19, or anonymous testimonies from alleged healthcare providers, some of which seem obviously untrue. This webinar considers how misinformation about clinical trials, treatments and vaccines can impact research progress.

The problem of the spread of scientific misinformation is very real. We’ve probably all seen stories on social media about COVID-19, or anonymous testimonies from alleged healthcare providers, some of which seem obviously untrue. This webinar considers how misinformation about clinical trials, treatments and vaccines can impact research progress.

COVID-19 and the effort to develop treatments and vaccines for COVID-19 have brought awareness of clinical trials into the public view like never before. What impact is that discussion having on the public’s understanding of clinical trials as part of the drug development process? In addition, there’s been extensive conversation about ensuring COVID-19 treatment studies include an appropriately representative population. How can we advance this important discussion to achieve diversity in research study enrollment?

As clinical trials shift quickly and necessarily from in-person to hybrid trials, remote visits, and virtual experiences and support, new opportunities and challenges emerge. While the industry figures out how to best navigate these new challenges, and much remains unresolved, we do know this: Sites and sponsors will be recalibrating everything, especially contract terms and budgets for either new components of trials or changes to clinical research. Site budgets for ongoing studies will need to be recalculated, amended and renegotiated, and contracts and budgets for new studies will have new considerations.

During this webinar, we highlight: the remdesivir development pathway and the experience of designing and conducting clinical trials in a brand-new disease without the benefit of medical guidance or regulatory precedent; The status and future of prophylactic vaccine development for COVID-19; The ethical issues of human challenge studies, which can speed vaccine development timelines but require careful consideration because they would intentionally expose study volunteers to COVID-19.

In this webinar, expert Ken Getz of Tufts CSDD, explores 3 facets of this transitional period: What the clinical research world was really like in 2019, by drawing from the rich data of the Tufts Center for the Study of Drug Development (CSDD); What the clinical research world may look like in 2021 and beyond, and the potential changes to the ways we design protocols, select clinical sites, and operationalize studies; Whether the public discussion of the development of COVID-19 therapies could potentially be a turning point in the public’s understanding, awareness and engagement with clinical trials.

In this podcast, Brian Loew, founder and CEO of online patient portal Inspire.com, talks about the value to patients and caregivers of providing a safe and trustworthy online social network — “peaceable kingdom,” as he calls it. Millions of patients representing 3,500 diseases — including many rare ones — come to Inspire.com for online community discussions focused on their own particular disease. The platform provides a place for meaningful conversations among patients and caregivers.

“Our research population should match our community population.” That’s one of the takeaways from Christopher Gantz’s podcast interview with WCG President of Patient Advocacy Steve Smith. He describes several programs that help connect researchers with minority communities to increase engagement and access enrollment in clinical trials. Listen to learn how the Sidney Kimmel Cancer Center’s success offers a model for other organizations to transform clinical trials.

This episode takes on a topic from recent headlines: namely, the racial disparity in COVID-19 cases and deaths. Edith P. Mitchell, MD, MACP, FCPP, shares her insights on the causes of these health disparities and how they relate to the coronavirus. Contributing factors include less access to testing, lack of insurance and paid time off, underlying health conditions, and the spread of misinformation about the virus.

In this podcast episode, WCG’s President of Patient Advocacy, Steve Smith, sits down for an interview with Dr. David Fajgenbaum, Assistant Professor of Medicine at the University of Pennsylvania and Author of Chasing My Cure: A Doctor’s Race to Turn Hope Into Action to discuss what it’s like to be a patient of a rare disease.

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.

Patient engagement solutions to expedite study recruitment.