According to a review from the National Library of Medicine, clinical trials can fail for many reasons. Among the top five pain points include problems with (i) patient recruitment; (ii) enrollment; (iii) retention; (iv) safety issues; and (v) failing to maintain protocols or FDA guidance. However, from mitigating FDA audit risks to managing patient recruitment and engagement, there is a range of site enablement solutions that effectively address these pain points for sites and site networks, head-on.
In this blog, we’ll explore five critical pain points for clinical research sites and how a Site Operations Management System (SOMS) – a total eClinical package – effectively addresses these challenges. Realtime-SOMS is a software bundle solution that includes CTMS, ENGAGE! (patient portal + eCONSENT), eSOURCE, eDOCS, SitePAY and TEXT – the perfect toolkit to expand your site management operations.
Pain Point #1: Accelerating growth and streamlining workflows for site management operations.
Solution: Scale site operations faster with a comprehensive Clinical Trial Management System (CTMS) for recruitment, finances, site management, and more.
A best-in-class CTMS allows sites to significantly expand their patient database by employing data-driven recruitment strategies that maximize enrollment. Combined with advanced custom reporting capabilities, sites gain invaluable insights into study performance and improve contract management, budgets, and accounting.
RealTime-CTMS is designed to seamlessly streamline participant visit tracking, scheduling, and participant communications, while automating many routine administrative tasks, such as document management, task assignment, and reporting. These features work together to reduce the administrative burden on research teams and accelerate the study start-up process. With automated processes in place, sites can avoid missing billing opportunities and ensure simplified financial workflows. Stakeholders can monitor financial data across all sites, from anywhere at any time, and make adjustments to improve performance as needed.
Site staff can easily get started with RealTime-CTMS almost immediately after acquisition. The system is highly customizable with built-in templates and workflows that simplify common clinical trial processes. This standardization ensures consistency and reduces the risk of errors during study start-up.
Pain Point #2: Patient retention alongside managing traditional consent processes and different versions of consent forms can be a logistical nightmare.
Solution: Manage all your studies at the site level with an integrated participant portal + eCONSENT.
Studies have shown that patients who are have the skills, ability, and willingness to manage their own health and health care tend to achieve better health outcomes. Addressing participant needs with convenience and transparency are further instrumental in retaining participants throughout a clinical trial. ENGAGE!, an integrated patient portal + eCONSENT solution, is uniquely designed to improve patient recruitment and retention. With ENGAGE!, participants are more likely to stay engaged with a study because their study information, including stipends and notifications, is readily accessible in both mobile and online applications.
Serving as a central hub for study participants is MyStudyManager™, a site-based participant portal within ENGAGE! MyStudyManager™, empowers participants to easily enroll in a study, manage their participation, and foster better engagement with site staff. Patients can access their specific study-related information, schedules, and even communicate securely with the site team through the portal. With features like notifications, study calendars and virtual visits, sites can significantly increase engagement and enhance the overall participant experience. Combined with RealTime’s TEXT feature, patient retention rates improve with consistent, streamlined communications.
Additionally, ENGAGE! offers eCONSENT capabilities which supports hybrid trials and expedites the consent process by allowing participants to digitally provide informed consent. This ensures that patients have easy access to study information, which in turn promotes a higher level of patient engagement and understanding. RealTime-eCONSENT also offers version control, assuring that participants are always signing the most current document.
Pain Point #3: Inefficiency, challenges and fraud risks associated with managing participant payments.
Solution: Boost patient satisfaction and eliminate fraud risk with SitePAY, a rapid, secure payment process.
A secure payment system boosts the overall participant experience and mitigates the risk of fraud. SitePAY enables the prompt distribution of stipends or reimbursements while retaining control and supervision through delegated user privileges for payment access.
Using SitePAY, sites can eliminate paper checks, cash handling, and reduce currency touch points with a rapid, secure payment process. Sites can also simplify reporting tasks with the convenience of 1099 reporting, which compiles a comprehensive report encompassing all the necessary data for electronic 1099 filing.
Pain Point #4: Error-prone paper processes that lead to inefficiencies and delays in data analysis. This can increase the risk of FDA audit findings.
Solution: eSOURCE enables real-time data collection and processing which enforces protocol compliance, significantly reduces errors, and enables remote monitoring.
eSOURCE stands as a powerful, 21 CFR Part 11 compliant solution that improves data quality and enforces protocol compliance. By replacing unreliable paper processes, eSOURCE significantly contributes to reducing FDA audit risk with more efficient, accurate, and cost-effective data capture management.
To facilitate collaboration and reduce errors, RealTime-eSOURCE allows users to create reminders for doctors and staff to make certain that critical actions are taken promptly. The system enables quick and efficient review, assessment, and signing of procedures, laboratory reports, and other critical documents. This in turn streamlines safety assessments and ensures timely responses to safety concerns.
RealTime-eSOURCE extends its benefits beyond data collection by also facilitating remote data access for sponsors and monitors. With the ability to review study data in real-time, eSOURCE eliminates the necessity for frequent on-site visits and labor-intensive manual data verification processes for sponsors. This functionality fosters improved oversight while simultaneously reducing costs linked to on-site monitoring.
Pain Point #5: Meeting regulatory requirements, including those from the FDA, is critical for sites. However, ensuring compliance can be resource-intensive and prone to human error.
Solution: eDOCS, an eRegulatory solution, seamlessly weaves compliance checks and reminders into site workflows.
A significant volume of data, documentation, and correspondence is created during a clinical trial. Organizing these records in a manner that ensures easy accessibility and adherence to regulations can be overwhelming. Historically, this process involved sorting through extensive paper documents, handling multiple spreadsheets, and managing numerous emails. As clinical trials become increasingly complex and the use of electronic data continues to surge, a more efficient and structured approach becomes essential.
eDOCS facilitates real-time access to essential regulatory documentation, thereby simplifying the complex task of maintaining compliance and ensuring that sites remain audit-ready. An invaluable addition to eDOCS is the Online Monitor Portal which allows both on-site and remote access for monitors, auditors, and inspectors.
Additionally, eDOCS introduces a standardized and customizable role system across various studies, enabling easy delegation of tasks. Moreover, the system expedites the collection of signatures from staff and investigators and offers a streamlined process for authorizing and managing all additions and changes to the delegation log.
Finally, RealTime-eDOCS leverages automated notifications to actively drive and maintain compliance, further fortifying its role as an indispensable system for sites.
Conducting clinical trials at your clinical research site comes with its fair share of challenges. RealTime-SOMS is built to address these pain points. SOMS, an eClinical bundle solution that includes CTMS, ENGAGE!, eSOURCE, eDOCS, SitePAY and TEXT, is the essential eClinical toolkit to modernize and grow your site operations. By providing real-time data management, patient engagement, compliance support, and a streamlined approval process, altogether, these solutions empower clinical research sites to conduct more efficient and effective clinical trials. As a result, you can expect to see faster breakthroughs and better outcomes.
Explore SOMS: See how RealTime helped one customer grow their revenue by 500% in this case study, Site Network Grows Revenue 500% with Realtime’s Comprehensive Solutions.