Starting up a new site can be a challenging and time-consuming process, often filled with unforeseen hurdles and delays. According to a Study by the Tufts Center for the Study of Drug Development, the average time from site identification to study start-up completion is approximately 31.4 weeks for Phase II and Phase III studies. The study also found that 11% of sites are never activated, meaning resources spent on these sites are wasted. Despite the essential role of the Clinical research industry, initiating a clinical study at a new site often takes a considerable amount of time, which can postpone the overall timeline of the research. This article will delve deep into the reasons behind the lengthy site start-up time and shed light on viable strategies to accelerate this process, as well as the role technology plays in these solutions.

Understanding the Intricacies of Site Start-up

Initiating a new site involves several stages, each with its unique set of requirements and potential bottlenecks, as depicted in Figure 1. From site selection and contract negotiation to site training and patient recruitment, the process is extensive and can be impacted by any number of delays at each of these stages. Each of these stages requires substantial time and resources, which cumulatively contribute to the lengthy start-up time. Figure 2 provides a brief overview of the various delays which may occur during the study start-up phase.

Figure 1. Overview of key clinical trial milestones during start-up.

Figure 2. Examples of delays that contribute to longer clinical trial start-up times. Causes specific to a study type are indicated by a symbol, with the legend in the bottom right corner. †Biologic. ‡Device. §Drug. *Observational.

Site selection and assessment

Embarking on the journey of clinical research site start-up begins with the process of site selection and assessment. This initial phase involves the identification of potential sites, a thorough assessment of their capacity to undertake the research, and the negotiation of contracts. This evaluation is a meticulous process – it requires the careful examination of the site’s infrastructure, equipment, and human resources. It also involves evaluating the site’s ability to recruit and retain the required number of patients with specific demographics or disease conditions. Further, the site’s prior performance in terms of its track record in handling clinical research, adherence to protocol, and data quality is also taken into account.

However, the delay in site start-up during this phase can be reduced by using a standardized site assessment tool. Such a tool would streamline the evaluation process and reduce the time spent on this phase. Moreover, considering the potential for future studies during the initial site selection can also contribute to reducing the time taken. It will ensure that the chosen site has the capacity not just for the current study but also for potential future studies, thereby reducing the need for repeated site selection and assessment processes.

Regulatory and ethics approval

The next major step in the clinical research site start-up process involves obtaining the necessary approvals from regulatory bodies and ethics committees. This phase is inherently time-consuming because it requires a meticulous review of the study protocol to ensure that patient safety and rights are protected. The Ethics Committee critically evaluates the ethical aspects of the study to ensure that the rights, safety, and well-being of the trial subjects are protected. The process involves the submission of documents like the study protocol, investigator’s brochure, participant informed consent form, and participant recruitment procedures, among others. These documents are reviewed to ensure they are in compliance with ethical guidelines.

This step can be expedited by having a well-structured protocol and documentation, which is clear, concise, and comprehensive. This would make the review process easier and quicker. Furthermore, Krafcik et al. (2017) reported that shorter start-up times were associated specifically with the use of a centralized Institutional Review Board (IRB) versus a local IRB to reduce approval times, as shown in Figure 3. According to their results, the longer the time needed to obtain IRB approval, the more likely a study was to experience enrollment delays.

Figure 3. Comparison of the number of days to IRB approval when using a local versus centralized IRB. Bars represent the standard error for each mean value. Abbreviations: IRB, Institutional Review Board.

Site initiation and staff training

The final step in the start-up of a clinical research site is site initiation and staff training. This phase begins with setting up the site, which includes the installation and calibration of equipment, providing sufficient training to all site staff per Good Clinical Practice (GCP) guidelines, setting up data management systems, and ensuring all necessary supplies are in place. To reduce delays during this phase, having standardized procedures and training materials can be beneficial because they ensure consistency and efficiency in the way tasks are performed, thus reducing the likelihood of errors. Additionally, ensuring that the staff has prior experience in clinical research can significantly reduce the time needed for training.

The Role of Technology in Streamlining Processes

The advent of technology is revolutionizing the way site start-ups are managed. Tools like artificial intelligence and advanced analytics are being used to quickly identify suitable sites and predict their performance, reducing the time spent in the selection and assessment phase. Additionally, digital platforms are being used to streamline the submission and review of regulatory and ethics approval documents, reducing the process from weeks to days. Digital training platforms are also being used to train staff remotely, reducing the time and resources needed for on-site training. By integrating digital solutions, the clinical trial process can be significantly accelerated, leading to quicker availability of new treatments and therapies for patients.

Vial CRO’s Technology: A Game Changer in Site Start-up

According to a study by Lamberti et al. (2018), there is a significant difference between the site start-up times of sponsors and contract research organizations (CROs). The researchers found that the median site initiation time for sponsors was 10.3 weeks, while for CROs, it was 9.6 weeks. Based on these results, CROs are, on average, more likely to initiate sites faster than sponsors alone, primarily due to the specialized clinical trial start-up expertise and resources these organizations are designed to provide.

Vial is a leading CRO at the forefront of this technological revolution addressing delays associated with traditional approaches to clinical trial management. In an attempt to streamline these processes, Vial CRO has developed a technology platform that encompasses electronic data capture (EDC), electronic patient-reported outcomes (ePRO), electronic source (eSource), and the Onboarding App. In addition to its technology, Vial also offers comprehensive support and training to ensure that users can maximize the platform’s capabilities.

Electronic data capture (EDC)

Vial’s EDC system allows for quicker and more accurate data capture compared to traditional paper methods. It not only reduces data errors but also accelerates data validation, which can significantly reduce the time taken for site evaluation.

Electronic patient-reported outcomes (ePRO)

The ePRO technology from Vial allows for real-time capture of patient-reported outcomes, which are essential for not only expediting the approval process but also ensuring data accuracy and validity. Its real-time nature enhances the quality of the data and provides a solid ground for ethics committees and regulatory bodies to base their approvals on, reducing delays in regulatory approvals.

Electronic source (eSource)

Vial CRO’s eSource allows for the electronic collection of data in its original state, which can then be used for direct reference during the study. This accelerates the site initiation process by providing quick access to source data, reducing the need for physical document handling, and minimizing data discrepancies.

Onboarding App

The Onboarding App is another innovative tool by Vial CRO that is helping streamline the site initiation process by providing an interactive platform for staff training. The application provides a standardized set of training materials that ensures all staff receive the same information, reducing the likelihood of errors and the time needed for training. Furthermore, the app also streamlines the process of site customization, allowing for quick modifications to fit the study-specific needs.

Conclusion

The lengthy process of site start-up is a significant challenge in the industry. However, with the advent of technology, and specifically solutions like Vial’s onboarding platform, the future looks promising. By embracing these innovative solutions, organizations can not only reduce their site start-up time but also improve their operational efficiency and outcomes. As technology continues to evolve, it is imperative for businesses to stay ahead of the curve and leverage these tools for a more efficient site start-up process. By doing so, they can ensure a faster, smoother, and more efficient start-up process, setting the stage for sustained success for clinical trial sponsors.

Vial is a full-service CRO that also recognizes the role of technology in the future of clinical research and is paving the way for modernized trial management through digital innovation. Trusted by leading sponsors, our specialized teams deliver shorter study timelines, quality affordable services, and a clinical trial experience that puts you first. Contact a Vial representative today to discover how we can help!