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In the ever-evolving landscape of clinical research, the ability to manage complex studies efficiently and effectively is paramount. Last Friday, I had the pleasure of speaking with Emma, a seasoned Systems Analyst at Riverbend Health, a leading Site Management Organization (SMO). Emma’s extensive experience in clinical research, spanning over a decade, has seen her work with an array of systems, including Advarra OnCore CTMS, REDCap, Florence eBinders, Veeva SiteVault eTMF, Medidata Rave CTMS, and more. Our discussion not only shed light on the current state of research systems but also highlighted some of the critical challenges and opportunities facing SMOs today.
The Struggles of Reporting with Advarra OnCore CTMS
One of the most pressing issues Emma shared was the limitations of Advarra OnCore’s CTMS, particularly regarding its reporting capabilities. According to Emma, the system’s inability to provide adequate built-in reporting tools has forced Riverbend Health to rely on external software like Power BI and Tableau. While these tools are powerful, the process of extracting data from OnCore and manipulating it in these platforms is both time-consuming and cumbersome. For a research institution managing multiple studies, this inefficiency can lead to delays and increased operational costs. Emma pointed out that this is how Riverbend Health currently conducts its reporting, underscoring a significant area for improvement.
How Cloudbyz eClinical Solutions Address This:
Cloudbyz eClinical solutions offer robust, built-in reporting capabilities that allow users to generate real-time insights without the need for external tools. Our platform provides customizable dashboards and reports that can be tailored to meet the specific needs of each study or site. This not only streamlines the reporting process but also ensures that study teams have access to accurate and timely data, enabling better decision-making and reducing the operational burden on research staff.
The Frustration of Managing Tasks Across Multiple Systems
Another major challenge Emma discussed was the frustration experienced by study teams and research administrators in managing tasks across multiple systems. This fragmentation is a common pain point in the SMO world, where different systems are often used for various aspects of study management, such as data capture, regulatory documentation, and participant tracking. The lack of integration between these systems not only complicates workflow management but also increases the likelihood of errors and delays. For study teams already stretched thin, the burden of juggling multiple platforms is a significant obstacle to efficiency and productivity.
How Cloudbyz eClinical Solutions Address This:
Cloudbyz offers a unified eClinical platform that integrates all aspects of clinical trial management into a single system. From CTMS and eTMF to EDC and Safety & Pharmacovigilance, our platform provides a seamless experience that eliminates the need to switch between multiple systems. This unified approach not only simplifies task management but also enhances collaboration across study teams, reducing errors and improving overall efficiency. By centralizing operations, Cloudbyz ensures that all stakeholders have access to the same real-time data, fostering better communication and more streamlined processes.
The Impact of Limited Customization and the Aging Workforce
The conversation also touched on the changes Advarra made to OnCore after acquiring Forte, specifically the restrictions placed on customization capabilities. Emma noted that these changes have led to dissatisfaction among users who previously relied on in-house programmers to tailor the system to their specific needs. With many of these programmers nearing retirement and the positions proving difficult to fill, sites like Riverbend Health find themselves increasingly vulnerable. The challenge of maintaining and adapting OnCore to meet evolving needs without the necessary expertise on hand is a growing concern, one that could have significant implications for the future of research site management.
How Cloudbyz eClinical Solutions Address This:
Cloudbyz eClinical solutions are designed with flexibility and ease of use in mind, reducing the reliance on specialized IT staff. Our platform is highly configurable, allowing users to adapt it to their specific needs without requiring extensive programming skills. This empowers research sites to make necessary adjustments and customizations in-house, mitigating the risks associated with an aging workforce and difficult-to-fill positions. Additionally, Cloudbyz provides continuous support and training to ensure that users can maximize the platform’s capabilities, even as their needs evolve.
Hesitation to Switch Despite Recognized Limitations
Despite the frustrations with OnCore, Emma mentioned that some sites remain hesitant to switch systems. This reluctance stems from the perceived complexity of transitioning to a new platform, even when the limitations of the current system are well recognized. The fear of disruption, coupled with the challenges of training staff on a new system, often outweighs the potential benefits of switching. For institutions with limited budgets, the prospect of a costly and complex migration is daunting, leading many to stick with a less-than-ideal solution.
How Cloudbyz eClinical Solutions Address This:
Cloudbyz understands the challenges associated with system transitions, which is why our platform is designed for ease of adoption. We offer comprehensive implementation support, including data migration services and user training, to ensure a smooth transition with minimal disruption. Our intuitive user interface reduces the learning curve, allowing staff to quickly become proficient with the new system. Moreover, Cloudbyz’s scalable pricing model ensures that institutions of all sizes can benefit from our solutions without breaking their budgets, making the switch to Cloudbyz a smart and accessible choice.
The Need for User-Friendly, Budget-Conscious Solutions
The demand for a more user-friendly system that does not require specialized staff is growing, particularly among institutions with tight budgets. Emma emphasized the importance of finding solutions that are not only easy to use but also affordable, allowing SMOs to focus on their core mission of advancing clinical research without being bogged down by technological challenges. This need is especially pressing in today’s environment, where the pandemic has accelerated the shift toward decentralized trials, challenging the traditional site-based trial model.
How Cloudbyz eClinical Solutions Address This:
Cloudbyz eClinical solutions are designed to be user-friendly and accessible to all levels of staff. Our platform simplifies complex processes, enabling research teams to manage studies more effectively without needing specialized technical expertise. We also offer flexible pricing options that cater to institutions with varying budget constraints, ensuring that even smaller sites can access the tools they need to succeed. Additionally, Cloudbyz’s support for decentralized trial models empowers sites to adapt to the evolving landscape of clinical research, ensuring they remain competitive and viable in a post-pandemic world.
The Cost of OnCore and the Future of Decentralized Trials
Finally, we discussed the cost implications of using OnCore, with Emma noting that the basic application costs approximately $200K to $300K annually, with many features being offered a la carte. This pricing model adds to the financial strain on institutions, particularly when combined with the other challenges discussed. Emma expressed concern about the long-term viability of sites that do not adapt to the new realities of decentralized trials, a trend that has only been accelerated by the pandemic. As SMOs navigate this shift, the need for cost-effective, integrated systems that can support decentralized trial models is more critical than ever.
How Cloudbyz eClinical Solutions Address This:
Cloudbyz offers an all-in-one solution that includes essential features without the need for costly add-ons. Our platform’s comprehensive suite of tools supports the full lifecycle of clinical trials, from study planning to post-market surveillance, at a fraction of the cost of traditional systems. This makes Cloudbyz an ideal choice for institutions looking to optimize their operations while managing their budgets effectively. Moreover, Cloudbyz’s support for decentralized trial models ensures that research sites can stay ahead of industry trends, maintaining their relevance and competitiveness in an increasingly digital world.
Conclusion
My conversation with Emma from Riverbend Health provided valuable insights into the current challenges and opportunities facing SMOs and research sites. From the limitations of existing systems like Advarra OnCore to the growing demand for user-friendly, budget-conscious solutions, it is clear that the landscape of clinical research management is at a crossroads. As the industry continues to evolve, the ability to adapt to new models and technologies will be crucial for the success of SMOs and the advancement of clinical research as a whole. At Cloudbyz, we are committed to developing solutions that address these challenges head-on, empowering research institutions to thrive in an increasingly complex environment. With Cloudbyz eClinical solutions, research sites can overcome the obstacles they face today and pave the way for a more efficient, effective, and adaptable future in clinical research.
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