The Benefits of eRegulatory for Academic Medical Centers 

As of March 2024, there are almost 150,000 clinical studies registered in the United States, with Academic Medical Centers (AMCs) overseeing a staggering volume of clinical trials annually across various therapeutic areas. At the forefront of medical innovation, patient care, and medical education, AMCs drive advancements in healthcare while nurturing the next generation of medical professionals. Researchers at AMCs have played a pivotal role in countless major medical advancements and have earned a reputation as primary healthcare destinations, ranking as the preferred choice for state patients, with 60% of patients favoring these facilities for their healthcare needs. 

Amidst their pivotal roles, AMCs navigate a complex and rapidly evolving healthcare environment. This necessitates stringent regulatory compliance to safeguard patient safety, preserve research integrity, and uphold institutional reputation. In this blog, “The Benefits of eRegulatory for Academic Medical Centers,” we’ll explore the unparalleled advantages that the adoption of eRegulatory platforms bring to AMCs.  

What is eRegulatory in Clinical Trials?

eRegulatory in clinical trials refers to the electronic management of regulatory and essential documents associated with the conduct of clinical research. This modern regulatory document management approach has gained prominence for its efficiency, accuracy, and streamlining of compliance in clinical trials.

The Unique Demands at Academic Medical Centers

AMCs have distinct needs, given their academic and research-oriented settings, which often include a combination of investigator-initiated and industry-sponsored trials. To maintain their high standards and contribute to cutting-edge research, AMCs are increasingly adopting eRegulatory platforms for improved compliance and patient safety. eRegulatory solutions that are specifically designed for the complexities of AMCs can offer integrated protocol management, enhanced document tracking, and streamlined collaboration tools. These capabilities lead to better data integrity, quicker study start-up times, and improved stakeholder engagement.   

The Benefits of eRegulatory for Academic Medical Centers

Standardize Compliance Across Departments

One of the primary goals of regulatory compliance at AMCs is to ensure patient safety. Standardizing compliance across departments is essential for maintaining regulatory integrity and ensuring seamless operations within an AMC. For instance, with RealTime’s eRegulatory platform, Complion eISF, AMCs can onboard various therapeutic divisions and departments at their own pace. This flexible approach allows for the implementation of efficient and standardized processes across the entire research portfolio. This leads to immediate consistency and compliance. By leveraging Complion eISF, AMCs can streamline regulatory workflows, enhance collaboration, and ultimately elevate the quality of research conducted across all departments.

Enhanced Data Integrity and Accuracy

In addition to ensuring patient safety, eRegulatory systems play a crucial role in enhancing data integrity and accuracy within AMCs. Traditional paper-based systems are prone to errors such as illegible handwriting, misplaced documents, and incomplete records. These inconsistencies can compromise the integrity of clinical trial data. Transitioning to electronic document management minimizes risks and ensures research data accuracy and completeness for AMCs. eRegulatory platforms offer features such as electronic signatures, version control, and audit trails, which provide a secure and traceable record of all regulatory activities. This not only improves data accuracy but also facilitates regulatory inspections and audits, saving time and resources for AMCs. 

Streamlined Collaboration and Communication

AMCs often involve multiple stakeholders, including principal investigators, research coordinators, regulatory affairs staff, and institutional review boards (IRBs). Coordinating the activities of these diverse teams can be challenging, particularly when using traditional paper-based systems. eRegulatory platforms offer a solution by providing centralized document repositories, task management tools, and communication channels that facilitate collaboration among stakeholders. This enables real-time access to regulatory documents, streamlined review and approval processes, and enhanced communication between team members. As a result, AMCs can accelerate study start-up timelines, improve operational efficiency, and ensure compliance with regulatory requirements. For instance, organizations using Complion eRegulatory experience twice the rate of study starts and fivefold faster inspection readiness. 

Efficient Study Start-Up and Maintenance

Timely study start-up is critical for the success of clinical trials. Delays can impact patient recruitment, data collection, and overall study timelines. eRegulatory systems streamline the study start-up process by automating routine tasks, such as document routing, signature collection, and protocol amendments. This reduces administrative burden, minimizes manual errors, and accelerates regulatory approval timelines. Additionally, eRegulatory platforms offer centralized dashboards and reporting tools that provide real-time visibility into study progress, compliance status, and potential bottlenecks. This enables proactive risk management and decision-making, ensuring that studies remain on track and within budget. Furthermore, eRegulatory systems facilitate ongoing study maintenance by providing tools for document updates, protocol deviations, and adverse event reporting. This ensures that AMCs can maintain compliance throughout the study and respond promptly to regulatory inquiries or audits. 

Why AMCs Prefer eRegulatory

eRegulatory systems offer numerous benefits for AMCs seeking to enhance their regulatory compliance, streamline operations, and improve patient safety. But not all eRegulatory platforms are created equal. Complion eRegulatory is tailored to address the unique complexities and stringent regulatory requirements inherent in AMCs. Unlike non-purpose-built platforms, Complion eRegulatory is designed to accommodate the high volume and diversity of clinical trials conducted within these AMCs. The system offers features such as customizable workflows, comprehensive document management capabilities, and integration with existing systems specific to academic research settings.  

By adopting electronic document management solutions, AMCs can achieve greater data integrity, streamline collaboration, and accelerate study start-up timelines. As the healthcare landscape continues to evolve, eRegulatory systems will play an increasingly important role in supporting the mission of AMCs to advance medical research, improve patient care, and drive innovation in healthcare.