At the center of every clinical trial lies a maze of regulatory requirements, from FDA regulations to institutional review board (IRB) approvals, and improving compliance in clinical trials remains an imperative. For academic medical centers (AMCs), ensuring compliance with these regulations can be an overwhelming task, often requiring extensive paperwork, meticulous documentation, and stringent adherence to protocols. However, by centralizing regulatory documents, protocols, and approvals within a secure digital platform, eRegulatory solutions eliminate the need for cumbersome paper-based systems. eRegulatory is a purpose-built eClinical solution that organizes the regulatory process, strengthens compliance, enhances efficiency, and safeguards patient data. Staff can easily access and manage regulatory documentation, track protocol amendments, and ensure compliance in real-time, reducing the risk of errors and expediting approval processes.
As AMCs manage the increasing complexities of clinical trials, the importance of a best-in-class eRegulatory system becomes increasingly clear. For AMCs considering an upgrade or adoption of new eRegulatory solutions, here are the top five eRegulatory features to consider:
1. Centralized Document Management System
In clinical trials, effective data management is vital for ensuring and improving compliance with regulatory requirements, as well as maintaining data integrity throughout the trial process. Academic medical centers must implement robust systems for data collection, storage, and analysis while adhering to standards such as Good Clinical Practice (GCP). Additionally, AMCs deal with a vast amount of documentation that must be stored and easily retrievable for audits and reviews. Effective eRegulatory systems deliver robust document management features that support version control, secure storage, and easy retrieval. eRegulatory systems centralize all regulatory documents, protocols, and approvals within a secure digital platform, eliminating the reliance on paper-based systems. This centralization is crucial for AMCs as it provides a single source of truth for all regulatory-related information, greatly simplifying access and management of critical documents.
Look for document management features that offer:
- Drag-and-drop functionality for easy document uploading.
- Encryption and secure access controls to protect sensitive information.
- Automated version control to keep track of document revisions and history.
2. Integration Capabilities
Integration capability is vital for efficiency. The eRegulatory software should seamlessly integrate with other systems used by AMCs, such as Clinical Trial Management Systems (CTMS), and other research management tools. This integration eliminates redundant data entry, reduces errors, and ensures that all systems are up to date with the latest study data.
Key integration features include:
- Single sign-on (SSO) capabilities to streamline user access.
- API access that allows for custom integration with new or existing tools as needs evolve.
3. Audit Trails
Audit trails help demonstrate compliance and can significantly mitigate risks associated with regulatory inquiries. eRegulatory platforms include automated audit trails that meticulously record every action taken within the system, driving transparency and accountability. This feature drives greater accountability by providing a detailed log that can be invaluable during audits or inspections.
Essential aspects to consider:
- Look for systems that meticulously record every action taken within the system, providing a detailed log invaluable during audits or inspections.
- Features like advanced filtering, search capabilities, and proactive monitoring can enhance the effectiveness of the audit trail.
4. User-Friendly Interface
For technology to be embraced by its users, it must be user-friendly. Prioritize solutions with intuitive interfaces that reduce training time, accelerate user adoption, and minimize resistance among staff. Thus, the best eRegulatory software offers a clean, easy-to-navigate interface that makes complex tasks more manageable.
Essential aspects of a user-friendly interface include:
- Clear, logical navigation that aligns with user workflows.
- Mobile-friendly design that allows users to work effectively from any device.
- Dashboards that provide quick access to the most needed information and tasks.
5. Comprehensive Reporting and Analytics
To continually improve trial outcomes and operational efficiency, AMCs need access to detailed analytics and reporting capabilities. The ability to generate comprehensive reports on trial progress, compliance status, and operational efficiency helps AMCs make data-driven decisions.
A sophisticated eRegulatory software should include:
- Customizable report generators that can adapt to the specific needs of your institution
- Dashboards that provide at-a-glance insights into study status and compliance issues.
Strategic Benefits for Academic Medical Centers
By providing a centralized platform for communication, document sharing, and task management, eRegulatory solutions facilitate collaboration among researchers, sponsors, regulatory agencies, and healthcare providers. Real-time updates, automated notifications, and version control ensure that all stakeholders are aligned and informed, enabling smoother workflows and faster decision-making. Whether working across different departments or collaborating with external partners, academic medical centers can leverage eRegulatory solutions to streamline collaboration and drive greater efficiency in clinical trials.
Designed to significantly reduce paperwork and ease compliance burdens for AMCs, Complion’s electronic Investigator Site File (eISF) platform, a RealTime Software Solutions product, is a trusted eRegulatory solution that efficiently manages various document types, including logs and signatures, for diverse studies and departments. With Complion’s eRegulatory/eISF, AMCs can securely onboard various therapeutic divisions and departments. They benefit from immediate consistency and compliance thanks to efficient, standardized processes across the entire research portfolio. Moreover, the secure and comprehensive management of documents and data protects sensitive patient information, which further supports the integrity of the research data.
For AMCs considering an upgrade or the adoption of new eRegulatory solutions, the system’s advanced automation and centralization features further reduce the administrative burden on staff, allowing them to focus more on the clinical aspects of trials and less on administrative tasks. For instance, with Complion, staff members can reclaim up to 30% of their day thanks to the reduction in manual, tedious tasks.
Finally, choosing the right eRegulatory software is critical for AMCs looking for a strategic advantage in achieving better outcomes and improving compliance in clinical trials. With the right tools in place, AMCs can focus more on what they do best – advancing medical research and patient care. Schedule a demo to see the Complion eRegulatory/eISF platform in action.
About RealTime Software Solutions
RealTime Software Solutions, LLC stands at the forefront of the industry as a premier provider of cutting-edge eClinical solutions tailored to the needs of clinical research sites, site networks, sponsors, and CROs. Our comprehensive suite of products includes the Clinical Trial Management System (CTMS), eRegulatory document management (eDocs), electronic data capture for source documents (eSource), participant payments (SitePay/GlobalPay), participant engagement solutions (Text, eConsent, and MyStudyManager™ Participant Portal), Complion eRegulatory/eISF, and Devana for pipeline management, study start-up, and business intelligence.
With a proven track record of empowering research organizations, we are committed to delivering innovative, user-friendly interfaces that redefine clinical research for clinical trials. Through our solutions, we aim to revolutionize how research is conducted, providing unparalleled efficiency and effectiveness at every stage of the process.
