For Academic Medical Centers (AMCs), health systems, and site networks conducting clinical trials, regulatory compliance and document management are pivotal to success. Yet, many institutions are still using legacy eRegulatory/eISF platforms that lack the functionality and efficiency needed to keep up with today’s demanding regulatory expectations. Outdated systems can lead to slower workflows, limited integration with other clinical trial systems, and increased compliance risks, all of which can hinder trial timelines and productivity. As clinical trials become more complex and more superior solutions emerge, it may be time to evaluate whether your current regulatory system truly meets your needs. This post explores 5 signs that you’ve outgrown your legacy eRegulatory platform.
1. Limited Flexibility and Customization
The Problem
Legacy eRegulatory platforms can often feel restrictive, especially for AMCs, health systems, and site networks managing a wide range of complex studies. These older platforms may struggle to keep pace with the varying requirements of different trials, lacking the flexibility to adjust to unique workflows, regulatory demands, or sponsor-specific needs. For sites managing multiple therapeutic areas or studies across multiple locations, this inflexibility can become a significant barrier, requiring time-consuming workarounds that slow down progress.
Considerations
A modern solution offers customizable templates and workflows that allow teams to tailor their processes to suit the unique needs of each study. For instance, with RealTime–eReg/eISF, built by the pioneers of eDocs and Complion eISF, users can configure document storage, workflows, and access permissions according to site protocols or study sponsor requirements, making it easier to scale and adjust as new trials and regulations arise. By enabling a tailored approach, RealTime helps research teams avoid the rigidity and workarounds often associated with outdated systems.
2. Inefficient Document Management and Search Capabilities
The Problem
An eRegulatory platform should make document retrieval and storage a breeze, but legacy systems can fall short in this area, especially if they rely on clunky file structures or limited search capabilities. Finding a document quickly is essential during audits or when staff members need urgent access. In legacy systems, like SharePoint, lack of document tagging, filtering, and advanced search options can lead to significant time wasted sifting through files.
Considerations
RealTime–eReg/eISF addresses this issue with a centralized, intuitive platform that organizes documents for fast retrieval. Search filters, tagging options, and customizable folders make it easy for users to locate the documents they need in seconds. RealTime’s platform also allows for real-time access, so remote teams and stakeholders can review documents simultaneously, further improving efficiency and collaboration.
3. Compliance and Audit Readiness Challenges
The Problem
Compliance is non-negotiable in clinical trials and ensuring that all documents are audit-ready is a fundamental part of the start-up phase. Legacy platforms may lack the robust compliance features required to meet today’s regulatory standards, putting research sites at risk during inspections. Without features like version control, automated audit trails, and real-time monitoring, sites using outdated platforms or non-compliant platforms like SharePoint face additional compliance risks and preparation time for audits.
Considerations
RealTime’s eReg/eISF solution is designed with built-in compliance tools that make regulatory adherence seamless. The platform includes version tracking, automated audit trails, and electronic signatures that comply with FDA 21 CFR Part 11 and ICH GCP guidelines, ensuring that every document meets the highest standards. Real-time monitoring and activity logs further enable teams to demonstrate compliance easily and address any findings efficiently.
4. Lack of Integration with Other eClinical Systems
The Problem
In today’s modern and increasingly hybrid clinical research environment, interoperability between eClinical systems is essential to streamline operations. Legacy eRegulatory tools can be limited in integration capabilities, making it challenging to connect them with CTMS, eSource, or other eClinical solutions. This lack of connectivity results in data silos, duplicate data entry, and increased risk of errors.
Considerations
RealTime–eReg/eISF is designed to integrate seamlessly with other eClinical tools, creating a connected, streamlined environment for clinical operations. This integration eliminates redundancies, enabling sites to manage regulatory documents alongside study activities and data collection. With RealTime, sites can link eReg/eISF with CTMS and eSource platforms to automate workflows and sync data.
5. Slow Audit Prep and Monitor Access Delays
The Problem
One of the biggest pain points with legacy eReg systems, or worse, paper-based processes, is how long it takes to prepare for audits and inspections. When documents are scattered across folders, systems, or physical binders, re-using commonly required files like CVs, licenses, and training logs becomes a manual, time-consuming task. Sharing essential documents with monitors often involves back-and-forth emails, downloads, or even printing.
Considerations
RealTime-eReg/eISF platform eliminates these delays by enabling centralized document storage, automated re-use of shared files across studies, and seamless monitor access through secure portals. If audit readiness still feels like a scramble at your site, it may be time to consider a system designed for speed, visibility, and compliance from day one.
Final Thoughts: Making the Switch
If any of these challenges resonate with you, it may be time to consider upgrading to a more powerful, enterprise-grade eReg/eISF solution. RealTime eReg/eISF is designed with scalability in mind, unlike some legacy systems that struggle to accommodate large, multi-site studies. Our solution grows with your team, offering options to configure workflows, templates, and user access dynamically. This flexibility makes it simple to integrate new trials or adapt to evolving regulatory requirements, which can be challenging on more static, outdated platforms
Upgrading from a legacy system may seem like a daunting step, but the benefits in time saved, efficiency gained, and compliance maintained make it well worth the transition. RealTime’s world-class customer support team will guide you through the process, ensuring a smooth migration and rapid adoption so that your team can quickly experience the advantages of a modern eReg/eISF solution.
Is it time to make the switch? Explore the advantages of RealTime’s eReg/eISF platform and discover a more effective way to manage your regulatory documents.
About RealTime eReg/eISF
From the pioneers of eDocs and Complion eISF, our user-friendly electronic document management and regulatory systems are built for clinical research sites and academic medical centers. Eliminate paper clutter and simplify document storage, retrieval, and collaboration across site teams or departments.
Read More: The Pitfalls of Using SharePoint for Compliance and Document Management in Clinical Trials
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