The Research Compliance Challenge

Navigating the complexities of research compliance demands precision and efficiency. With multiple departments and stakeholders involved, ensuring compliance often becomes time-consuming. Constant policy updates and heightened scrutiny further add to the challenge of research institutions and organizations.

Evolving Regulatory Landscape

Intense scrutiny and frequent policy changes require organizations to maintain constant vigilance and adaptation to compliance standards.

Administrative
Burden

Inefficient manual processes such as meeting management, agenda setting, proposal submissions, and document routing keep lean teams tied up in routine tasks, slowing down progress.

Complex IT and Data Maintenance

Research compliance touches multiple domains, each with unique requirements. Teams often struggle with system integration, data security, & legacy systems, slowing progress, increasing risk, & reducing efficiency.

Multi-stakeholder Coordination

With multiple stakeholders investigators, coordinators, reviewers, and compliance officers the IRB approval process becomes time-consuming and complex, leading to delays.

With eProtocol, you can overcome these challenges and convert compliance from a routine burden into a strategic, real-time advantage.

Why Choose Key Solutions IRB Automation Software

Our eProtocol software extends intelligent IRB workflows that automate manual processes involved in IRB protocol submission for accelerating approvals.

Intelligent Automation for Streamlined Compliance

Simplify protocol submissions and renewals with an intuitive platform, making compliance tasks faster and more efficient.
Reduce administrative burden on lean teams by automating IRB submission and approval workflows, freeing up time for higher-priority tasks.
Work with standardized IRB digital compliance workflows across all sites and subsidiaries.

Real-Time Monitoring

Centralized dashboards offer real-time visibility into key metrics and enable easy tracking of IRB approvals, renewals, and adverse event reports.
Automated protocol submission and review workflows streamline processes, reducing turnaround times.
Automated reminders for expiring approvals and alerts for renewals ensure no critical milestones are missed.

Centralized Access for Seamless Collaboration

Streamline document management by securely storing approvals, information, and supporting documents in a centralized and accessible location.
Built-in compliance documentation and audit-ready records facilitate hassle-free FDA inspections.
Integrate protocol data with clinical operations systems, aligning protocol approvals with trial activation for enhanced efficiency and smooth progression.

Data-Driven Insights for Research Excellence

AI-powered intelligent assistance automatically identifies compliance issues and errors.
Smart forms and automated workflows streamline the entire protocol lifecycle—from submission through approval—by eliminating manual data entry and automating routine administrative tasks that typically slow down the review process.

Stop managing compliance chaos - make the smart choice.

Backed by years of industry experience, Key Solutions is trusted by leading research institutions to accelerate IRB compliance. Experience faster reviews, enhanced collaboration, and unmatched regulatory adherence.

Frequently Asked Questions

1. How does the Key Solutions IRB system work?

The IRB system automates the management of research compliance involving human subjects. From protocol development and submission to tracking, review, approval, and audits, the entire process is digitally streamlined, offering flexibility while ensuring flawless compliance with regulations.

2. Will the software integrate with our existing research administration systems?

Yes, our eProtocol software is designed for seamless integration with popular research administration platforms, grant management systems, and institutional databases. Our technical team conducts a thorough assessment during the planning phase to ensure compatibility and smooth data flow across systems.

3. How long does it take to implement an IRB system?

Implementation of eProtocol IRB management software typically takes 4-8 weeks for most institutions, depending on complexity and customization requirements. This includes system configuration, data migration from existing systems, workflow setup, user training, and testing phases. Our implementation team works closely with your staff to ensure minimal disruption to ongoing research activities while maximizing the system's effectiveness for institution-specific needs.

4. How does the software stay current with changing federal regulations and institutional policies?

We continuously monitor federal agencies (FDA, OHRP, NIH) for policy updates and update our software accordingly, ensuring your protocols remain compliant as regulations evolve. In addition to this, we train our team on the new guidelines so they can help clients better.

5. Can Key Solutions IRB automation software handle multi-site compliance?

Yes, Key Solutions IRB automation software is designed to handle IRB compliance across multiple sites. It standardizes compliance workflows and ensures that all sites follow the same protocols, which enhances efficiency and consistency.

6. Can the IRB compliance system integrate with other systems?

Yes, the IRB software seamlessly integrates with other systems such as IBC, SCRO, RSC, CSC, and CS. Additionally, it can work in tandem with our Grants Management and Conflict of Interest modules, providing a fully unified and efficient compliance solution.

7. Can IRB software reduce audit preparation time?

Yes, IRB compliance software can reduce audit preparation time by 70-80% compared to manual systems. Automated systems maintain complete, time-stamped audit trails, generate standardized reports instantly, and ensure consistent documentation practices. With built-in audit ready documentation, everything is readily available in organized, searchable formats, eliminating the need for manual file compilation.

8. What are the costs of managing IRB compliance manually vs. using software?

Manual IRB compliance management typically costs institutions 3-5 times more than automated solutions when considering staff time, administrative overhead, error correction, and audit preparation costs. Manual processes require extensive staff hours for document management, meeting coordination, audit trail management, compliance tracking, etc. Most institutions using regulatory compliance software experience reduced administrative burden, faster review cycles, improved accuracy, and decreased audit preparation time.