Join us for “Breaking Down Site Complexities and Start-Up Barriers in Clinical Trials” as we uncover the complexities of site management and the barriers to effective study start-ups. Discover the top issues impacting research sites and strategies to overcome them, including trial complexity, start-up hurdles, and long initiation timelines.  

Learn how effective communication, teamwork, and clear processes can drive success, and the importance of human connections and inclusivity in clinical research. Get practical advice for improving site readiness and trial efficiency from our expert guests.  

Don’t miss this essential episode on navigating the evolving clinical trial landscape at sites. 

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Traditional IBC processes can be deferentially slow, adding critical delays to clinical trial timelines. WCG’s IBC+ addresses this issue head-on by providing a streamlined, expert-driven solution that significantly reduces turnaround times—by up to 50%—without compromising the quality of biosafety evaluations. This means faster site activations and study start-ups, which ultimately brings life-saving treatments to patients sooner.

“IBC+ accelerates biosafety oversight in gene transfer studies,” said Sam Srivastava, chief executive officer, WCG. “By combining comprehensive oversight with expert support and efficient processes, we empower research teams to begin their trials faster while maintaining the highest standards of safety and compliance. This is another step forward in our commitment to accelerate clinical trials and deliver essential therapies to market more quickly.”

WCG’s IBC+ leverages the company’s ISO 9001 certified IBC and a dedicated team with more than 200 years of combined experience in gene transfer research. This ensures a high-quality review process that meets stringent biosafety standards, even on an accelerated timeline.

For sponsors and researchers, IBC+ offers several key advantages:

• Accelerated Timelines: Faster regulatory review processes that can reduce site activation and study start-up time by up to 50%, saving months on trial timelines.
• High-Quality Reviews: Streamlined processes that maintain rigorous biosafety compliance, ensuring the integrity and safety of the trials.
• Expert Support: A dedicated biosafety team well-versed in navigating complex regulatory frameworks, providing essential guidance and support throughout the trial process.

Combined with WCG’s IRB+, which reduces study timelines by months and lowers overall costs associated with clinical trial delays, IBC+ ensures that sponsors can achieve site activation and study start-up faster for trials involving genetically engineered products. This dual approach provides unparalleled efficiency and a streamlined pathway for both ethical and biosafety reviews.

“Our goal with IBC+ is to optimize the regulatory review process while upholding the highest levels of biosafety and ethics,” added Kelly FitzGerald, executive IRB chair and vice president, IBC Affairs. “This is crucial for the success of gene transfer studies and pivotal in advancing medical research efficiently. We’ve already seen great success in streamlining operations with IRB+, and we’re thrilled to bring those efficiencies to IBC as we strive to have the best-run ethical and biosafety review operations in the industry.” For more information on WCG’s IBC+ solution, visit www.wcgclinical.com/introducing-ibc-plus/.

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Navigating Recruitment and Retention with Ease

WCG ClinSphere™ Total Enrollment places the power of efficient recruitment and retention management into the hands of study teams. Here’s how it stands out:

1. Comprehensive Control and Configuration: Sponsor users can easily set up, manage, and deploy recruitment and retention programs. With configurable tools like optimized prequalification forms, ensuring that only the most suitable participants advance in the trial has never been easier.
2. Informed Decision-Making with Real-Time Insights: A significant advantage of Total Enrollment is its ability to provide real-time access to essential participant metrics. This instant data availability allows study teams to monitor progress, identify challenges, and implement proactive strategies to enhance the success of their studies.
3. Centralized Referral Activities: Total Enrollment enables centralized management and tracking of participant referrals, regardless of their source. This unified approach provides visibility into when and where additional referrals are necessary, ensuring no participant falls through the cracks.
4. Scalable Solutions for Any Study Size: Whether managing a small, localized trial or a large-scale, global study, Total Enrollment is designed to adapt and grow with the study’s needs. This scalability ensures that study teams have the tools they need at every stage, while maintaining flexibility and control.
5. Proven Success Across Diverse Studies: ClinSphere™ Total Enrollment is built from feedback from clinical sites and based on a proven methodology that has delivered measurable success across a range of studies and therapeutic areas.

Empowering the Future of Clinical Trials

The key to transforming clinical trial operations lies in leveraging advanced technology to optimize participant management. WCG ClinSphere™ Total Enrollment offers a scalable, data-driven solution that keeps study teams well-informed and aligned. With real-time insights and centralized control, the solution helps ensure smoother execution and improved outcomes.

To learn more, visit wcgclinical.com/totalenrollment.

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Total Enrollment streamlines recruitment and retention programs, offering study teams unparalleled visibility and control over these workstreams. Powered by WCG’s ClinSphere technology platform, this solution is designed to simplify participant tracking and reporting with self-service tools and data-driven insights, enabling smarter decisions for more efficient trial management.

“Recruitment and retention have long been major pain points for clinical trials, contributing to costly delays and incomplete data,” said Sam Srivastava, chief executive officer, WCG. “Total Enrollment addresses these challenges head-on by providing study teams with a powerful, user-friendly solution to manage recruitment and retention efforts in real-time, improving trial outcomes and accelerating time to market for life-saving treatments.”

WCG ClinSphere Total Enrollment was developed with the needs of both sponsors and research sites in mind. For sponsors, the technology offers full visibility into recruitment metrics and retention rates, ensuring they can proactively manage enrollment timelines and address potential bottlenecks. For sites, it simplifies the complexity of tracking participants, providing automated tools that streamline communication, reporting, and participant management.

“Our goal is to equip both sponsors and sites with the tools they need to recruit participants more effectively and keep them engaged throughout the trial process,” said Paul Mancinelli, chief technology officer, WCG. “Total Enrollment not only helps accelerate recruitment but also enhances retention by maintaining participant engagement long after enrollment, which is crucial for study success.”

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How do primary investigators (PIs) report promptly reportable information (PRI) in a blinded* study? How can they report unblinded information without unblinding themselves?

*While in ophthalmology studies the term “masked” is used, blinded will be used here as it is the most commonly used terminology.

Answer

For WCG’s Institutional Review Board (IRB), reporting protocol deviations are required if the deviation harmed a participant or placed a participant at risk of harm. You can review our list of events that require reporting, when disclosing through our portal, on our Promptly Reportable Information Form (HRP-204) or in our Guide for Researchers.

When reporting PRI in a blinded study, there are two issues to consider:

1. Unblinding the participant to see the randomization, e.g., whether they were assigned a placebo or the investigational product (IP).
2. Unblinding a blinded clinical study team member as a result of reporting the participant’s clinical information as a PRI.

For the first issue, WCG’s IRB doesn’t require universal unblinded reporting. In most cases, sufficient information is available without unblinding to allow the IRB to determine if the issue requires further follow up and action. If insufficient information is provided, we will follow up and ask for specifics. If unblinding is required, we will request that information with a rationale. For example, if an overdose occurs, unblinding is not necessary for reporting as the issue is the overdose. Overdosing is a problem because it’s the process that led to the overdose that is the risk. In this case, the most important information to provide is the Corrective and Preventive Action (CAPA) plan that identify and address the root causes of noncompliance and prevent future occurrences.

Unblinding the participant to manage an adverse event would only be necessary if the clinical information is required for corrective actions to address the immediate problem. If the participant or staff were unblinded, WCG’s IRB would need to be informed of this.

Out of respect for persons and to encourage trust through transparency in research, we believe it is important to inform participants about research errors. That does not require you to unblind to inform the participant. For example, if the site is aware that a participant in a double-blind, randomized study received the IP that was intended for another participant, unblinding isn’t necessary to tell the participant that they received the study drug intended for another participant. Instead, inform them of the importance of blinding to address the reason for not providing more detail.

For the second point, the issue is unblinding blinded study staff. This could occur either because of a blinded study team member being unblinded or unblinding themselves, or this could be due to the reporting of an event where the details or data included in the report could unblind a staff member. In the case where a staff member is unblinded, the act of unblinding them wouldn’t have to be reported unless the unblinding put a participant at risk or met one of the other reportable categories. If in doubt, the event can be reported that a blinded study staff was unblinded, without the specific data that would unblind others.

In the case where the reporting of the event details might unblind staff, this is best managed through reporting events in a way that doesn’t include the specifics which would unblind. There are very few and limited circumstances in which the site or sponsor would need to report an event to the IRB that would unblind the site where the site wasn’t already needing to be unblinded.  

In either situation, good communication with the IRB is important. If you have any questions, please don’t hesitate to contact us. Our experts are always ready to assist you with your questions. Whether you have additional questions about reporting PRI in a blinded study or other IRB inquiries, our team is here to provide the guidance you need. Submit your questions to our IRB experts here.

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Leveraging WCG’s extensive expertise, the report identifies five pivotal focus areas for 2025: 

1. AI and Machine Learning – Enhancing operational efficiency by revolutionizing trial design, participant recruitment, and site performance. 

2. Site Preparedness for Future Clinical Trials – Elevating infrastructure, training, and collaboration to drive site success and participant engagement. 

3. Regulatory Innovation and Single IRB Models – Streamlining review processes to reduce redundancy and accelerate multi-site study start-up times. 

4. Precision Oncology and Biomarker-Driven Trials – Delivering a new gold standard in personalized medicine with targeted, biomarker-based approaches. 

5. Diversity in Clinical Trials – Breaking barriers to representation through innovative recruitment models and community engagement strategies, ensuring equitable access to life-changing therapies. 

“The 2025 WCG Trends and Insights Report encapsulates the innovation and personalization that define the future of clinical research,” said Sam Srivastava, chief executive officer of WCG. “At WCG, we are committed to empowering stakeholders across the research ecosystem with actionable insights that improve outcomes, accelerate trials, and ultimately, improve patient care. This year’s report is both a roadmap and a call to action for advancing clinical trials with purpose and precision.” 

With these key themes, the report equips sponsors, CROs, sites, and regulators with the valuable insights needed to effectively navigate an evolving landscape, from the rise of artificial intelligence to the imperative need to foster diversity in clinical trials. Successfully addressing these areas will ultimately lead to better clinical outcomes in our industry, enhancing participant care and ensuring the delivery of more efficient and effective therapies to patients worldwide. 

The 2025 WCG Trends and Insights Report is now available. To access the report, visit wcgclinical.com. 

The post WCG Unveils 2025 Trends and Insights Report: Driving Innovation and Excellence in Clinical Research appeared first on WCG.

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Diversity in Clinical Trials 

In recent years, diversity, equity, and inclusion (DEI) have become essential focus areas in clinical trials, with a primary goal of increasing participant diversity. However, the push for inclusivity extends far beyond enrollment numbers. According to WCG data, participant diversity has improved significantly, with minority representation in trials increasing by 25% from 2018 to 2022. Gender representation has also seen a positive shift, with women now constituting 52% of trial participants, a notable increase from 45% in 2018. Additionally, our data indicates that the geographical reach of our clinical sites has expanded, with principal investigator (PI) locations now covering more diverse regions, enabling greater participation from varied demographic groups. 

To address the evolving DEI practices, clinical trials are now designed to account for genetic, lifestyle, and environmental factors unique to different demographic groups. This approach aims to build a foundation for treatment decisions that better serve all patients, reducing healthcare disparities and fostering broader public trust. Data from WCG shows that trials incorporating these inclusive designs report a 30% higher retention rate among diverse populations. 

As we progress, focusing on equitable data representation is critical to producing results that truly represent the global patient population, helping sponsors, regulators, and clinicians make informed, inclusive healthcare decisions.  

Discover WCG’s expert perspectives on advancing DEI in data for the next generation of clinical trials:

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Site Preparedness for Future Clinical Trials

The ability of clinical trial sites to operate efficiently and adapt quickly to sponsor needs is crucial for successful trial execution. According to WCG’s 2024 Clinical Research Site Challenges Report, a common hurdle is the need for improved communication and streamlined collaboration between sponsors and sites. Addressing these challenges requires building a framework that supports better site readiness, including enhanced training, real-time data access, and clear communication pathways. 

The report highlights that 78% of sites experience delays due to poor communication, and 65% of sites identify the lack of real-time data access as a significant barrier. Additionally, 72% of sponsors believe that enhanced training would substantially improve site performance. When sponsors work closely with sites to align on protocols, timelines, and resources, the likelihood of avoiding delays and mitigating site-level challenges increases significantly. As we look to future trials, empowering sites with the necessary tools and support is key to ensuring streamlined operations, timely participant recruitment, and high-quality data collection, ultimately setting a strong foundation for trial success. 

Learn more from WCG’s experts on advancing site readiness for future clinical trials:

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Artificial Intelligence and Machine Learning in Clinical Trials

According to recent studies from the Tufts Center for the Study of Drug Development, the integration of artificial intelligence and machine learning in clinical trials can reduce study timelines by up to 30% and cut costs by as much as 20%. Predictive models powered by AI can analyze vast datasets, identifying potential delays and risks before they arise. This proactive approach allows sponsors and CROs to allocate resources effectively, cut down on trial duration, and reduce costs. 

In addition to operational efficiency, AI-driven analytics are enhancing the precision of patient recruitment and retention, and endpoint tracking, ensuring that trials stay on course to meet their objectives. By leveraging these technologies, clinical research is becoming more adaptive, agile, and cost-effective, opening the door to an era of more dynamic and efficient clinical trials. 

Read on to explore how WCG’s thought leaders are driving AI innovation in clinical trial operations:

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Precision Oncology and Biomarker-Driven Trials  

The global market for precision oncology is on track to reach $98 billion by this year, highlighting the growing investment and interest in this field. This surge in personalized medicine is underscored by the rise of basket and umbrella trials, which enable the concurrent testing of multiple targeted therapies across various cancer types or genetic mutations. 

Precision oncology is swiftly revolutionizing cancer treatment by emphasizing biomarker-driven trials that target specific genetic and molecular profiles. Biomarkers, which are measurable indicators of biological processes, pathogenic processes, or responses to an exposure or intervention, are not limited to oncology but play a pivotal role across a range of medical fields. These markers help guide researchers in identifying which patients are most likely to benefit from specific therapies, thereby personalizing treatment approaches. 

As our comprehension of cancer genomics expands, clinical trials are increasingly tailored to individual patients, often based on the unique biology of their tumors. Biomarkers play a crucial role, guiding researchers in identifying which patients are most likely to benefit from specific therapies. 

This targeted methodology not only enhances the effectiveness of treatments but also reduces unnecessary exposure to ineffective therapies, thereby improving patient safety. The shift towards biomarker-driven trials in oncology and other therapeutic areas like CNS signifies a move toward a more personalized, data-driven approach to treatment, which holds great promise for improving patient outcomes. 

Discover WCG’s expert perspectives on the future of precision oncology and the design of biomarker-driven trials:

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Advancing Precision Medicine in Oncology: From One-Size-Fits-All to Biomarker-Driven Treatments

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Regulatory Innovation  

In an era where clinical research is more complex than ever, regulatory innovation is essential to streamline processes and safeguard participants’ rights while accelerating the development of life-saving treatments. As the research landscape continues to evolve, regulatory bodies like the U.S. Food and Drug Administration (FDA) are taking significant steps to modernize and harmonize regulations, making it easier for sponsors, institutions, and investigators to conduct trials that meet high standards of rigor and efficiency.  

One major focus of regulatory modernization is the push for single IRB (sIRB) review in cooperative research. This approach, already mandated by the Common Rule for federally funded studies, requires only one Institutional Review Board to oversee research involving multiple institutions, reducing duplicative reviews and expediting study initiation.  

The FDA’s proposed rule to mandate single IRB review in FDA-regulated research marks a critical alignment with the Common Rule, signaling a step toward consistency across regulatory frameworks. While the proposed rule would streamline oversight and reduce administrative burdens, the FDA has outlined specific exceptions for cases where local expertise is crucial, or where product-specific regulatory pathways apply.  

Though many sponsors have already adopted single IRB practices voluntarily, FDA’s formalization of this requirement will necessitate changes for some institutions and investigators. Adjustments to standard operating procedures (SOPs) and resource allocation will be necessary, particularly for those who have not yet transitioned to this model. With the final rule anticipated this year, stakeholders have an opportunity to align processes in anticipation of this shift.  

The following provide deeper insights on single IRB (sIRB) review, including an analysis of the FDA’s proposed rule and an overview of the rulemaking process. Together, these perspectives illustrate how regulatory innovation is reshaping the clinical trial landscape and advancing research efficiency for all stakeholders.  

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The post Clinical Trial Trends & Insights for 2025 appeared first on WCG.

The following Insight is a featured article from WCG’s 2025 Trends & Insights Report. If you would like to read more insights from this report, please click here.

The FDA’s draft guidance on Diversity Action Plans brings a renewed focus and attention to initiatives that will assist in recruiting more diverse populations in clinical research studies. Its final guidance is anticipated to be released this year. Including populations in research who are most likely to use the study drug or device once it’s on the market can lead to more effective treatments and a better understanding of potential adverse events. This guidance will increase the confidence of those healthcare providers prescribing the newly approved products.  

The draft guidance may prompt stakeholders to implement solutions from various angles, but they could overlook the most crucial aspect. Focusing solely on numerical targets for diversity action plans rather than addressing the human element involved in recruiting diverse populations misses the broader objective. A concerted effort is required within communities to raise awareness of clinical research, the sites conducting that research, and the sponsors involved. This effort can increase trust in the clinical research process in more communities, thereby recruiting more participants from more diverse backgrounds. It is also crucial to treat every potential participant with respect and dignity. This includes fully informing them about the studies for which they are eligible and emphasizing the benefits for the participants, not just for the sponsor or site.

On-site study interactions are also critical. According to the Tufts Center for Drug Development Impact Report issued in November/December 2024, discriminatory behaviors from study staff harm trust and patient enrollment diversity. Tufts reported that potential participants of color who cite that study staff devalue their pain or medical symptoms or display impatience when asked about medical procedures are less trusting of study outcomes and less willing to participate in future trials.  

A recent Research America National Survey on Clinical Trials found that while 49% of those surveyed were willing to participate in a clinical trial, only 26% reported that they or someone in their family has actually participated. Additionally, the top reasons for not wanting to participate included distrust, adverse side effects, and lack of awareness or information. If the clinical research industry can come together to alleviate the distrust and inform potential participants about the clinical research process, it can increase the number and diversity of study participants globally. While the trust-building phase allows a minimal margin for error, the effort yields significant rewards: improved treatments for everyone.  

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The post Diversity in Clinical Research: Every Participant Counts appeared first on WCG.

The following Insight is a featured article from WCG’s 2025 Trends & Insights Report. If you would like to read more insights from this report, please click here.

Diversity in clinical trials is not just a matter of fairness— it is a scientific imperative. Historically, clinical studies have underrepresented certain populations, which has led to gaps in our understanding of how different groups respond to medical treatments. A 2020 FDA report showed that 75% of participants in clinical trials for new molecular entities were white, while only 11% were Hispanic or Latino, 8% were Black or African American, and 6% were Asian. But the disparities can often go beyond race, traced to gender, age, socio-economic representation, and even sexual orientation. This lack of diversity can result in disparities in health outcomes, as treatments may not be as effective or safe for all population segments.  

The FDA Guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies is expected to be released this year and represents a significant step forward in addressing these disparities. This guidance emphasizes the necessity of incorporating Diversity Action Plans (DAPs) in the planning and execution of clinical trials. By mandating that researchers proactively include participants from diverse backgrounds, the FDA aims to ensure that clinical trial results are more generalizable and applicable to the broader public.  

Moreover, participant engagement is expected to see significant improvements. With a focus on diversity, trial designs can be more inclusive, addressing potential barriers such as language, cultural sensitivities, and logistical challenges. Engaging community leaders and leveraging local resources can also enhance participation rates and retention. As sponsors look to understand the impacts their trials have on all types of diversity, there are dual-sided benefits, in that sponsor companies are educated on the public’s perception of clinical trials, specifically from diverse participants, and the public is educated more on the actual clinical trial process. By prioritizing the inclusion of diverse populations, educational initiatives can be tailored to raise awareness and understanding about the importance of clinical trial participation among underrepresented groups. This can lead to better engagement and trust in the medical research process.  

Site identification is another critical area where the FDA’s guidance will play a pivotal role. Identifying trial sites in areas that serve underrepresented populations will be imperative to enrolling more representative trial populations. This strategic approach can enhance the study findings’ relevance and foster equity in clinical research.  

The benefits of this guidance are profound. For the scientific community, it means more robust and reliable data, leading to better-informed decisions about the efficacy and safety of treatments across diverse populations. For public health, it translates to more personalized and effective healthcare interventions, ultimately contributing to reduced health disparities and improved outcomes for all. The upcoming finalization of the FDA Guidance on Diversity Action Plans is a crucial development that promises to enhance the inclusiveness and relevance of clinical trials. By fostering diversity, we move a tiny step closer to achieving equitable healthcare and advancing public health for everyone.  

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