Executive Summary
According to a comprehensive study, Principal Investigators report that 44.3% of their research time dedicated to federally funded projects is consumed by compliance tasks and administrative requirements, leaving less time for actual research.
Many institutions still rely on siloed systems to manage IRB, IACUC, or IBC compliance. But what specifically makes these systems burdensome? Research shows that the administrative burden comes from:
- Fragmented workflows: Separate systems for each committee force researchers to log into multiple platforms, re-enter the same information repeatedly, and manually coordinate between systems.
- Manual tracking requirements: Researchers must use spreadsheets to track approval statuses, training certifications, and protocol amendments because systems don't provide integrated visibility.
- Poor system performance and reliability: Slow processing of information by central servers, frequent system failures, and connection issues that force researchers to restart tasks and lose work.
- Non-optimized user interfaces: Confusing navigation, incomprehensible administrative terminology and coding systems, and interfaces that require multiple clicks to accomplish simple tasks.
These system design problems—not researcher capability—create the administrative burden that consumes nearly half of PI research time.
The Modern Alternative
The intelligent platform like Key Solutions’s eProtocol addresses these specific pain points:
- Unified platform: All committee requirements (IRB, IACUC, IBC, RSC, CSC, SCRO) managed in one system, eliminating multiple logins and duplicate data entry.
- Streamlined workflows: Documents can be routed to institutional managers for internal review before committee submission, reducing back-and-forth delays.
- Proactive alerts: Automated notifications for training renewals, approaching deadlines, and required protocol updates—eliminating manual tracking.
- Completeness checks: Built-in validation ensures all required information is provided before submission, preventing the 2-6 week delays caused by incomplete submissions being sent back from committees.
- Single source of truth: When protocols are amended, all related documentation references the current approved version, eliminating version control problems that surface during audits.
By addressing the root causes of administrative burden—system fragmentation, poor interfaces, and manual processes—eProtocol enables researchers to spend more time on actual research and less time navigating compliance systems.
Read on to discover how you can overcome compliance challenges and set your teams up for long-term success.
Every week, research teams spend valuable hours tracking protocol approvals, navigating different systems to check committee decisions across IRB, IACUC, IBC, RSC, CSC, and SCRO committees, and managing multiple documentation requirements across diverse research domains.
Then, during audits or reviews, compliance gaps arise that were previously overlooked.
This is the reality for most research teams today.
What once was a simple process of committee approvals has evolved into a maze of complex requirements. Human subjects protocols, animal welfare procedures, biosafety submissions, radiation safety documentation, chemical handling protocols, and stem cell research oversight: Each committee operates with different systems, timelines, and documentation standards.
The result? Teams spend more time managing compliance than actually conducting research.
However, what many institutions don't realize is that the biggest compliance risks in research aren't random and they follow predictable patterns. Understanding these patterns can prevent problems before they occur.
After working with research institutions, experts have identified where compliance breaks down and how to resolve it. With the right approach, you can:
- Stop playing catch-up with compliance: Instead of discovering problems during reviews, you'll know about potential issues weeks in advance.
- Eliminate the system-switching nightmare: Manage all your committee requirements, including IACUC, IBC, RSC, CSC, and more from one place.
- Significantly reduce your documentation time: Automated workflows handle the repetitive tasks while you focus on research.
- Never miss a deadline again: Real-time tracking shows you exactly what needs attention and when.
Most importantly, walk into any audit with confidence: Complete documentation trails are automatically maintained for every protocol.
That's what you get from Key Solutions AI-powered eProtocol platform, which has been specifically designed for the unique challenges of research compliance.
In this guide, you'll learn more about eProtocol capabilities along with the compliance insights that most institutions discover only after costly mistakes. You'll also understand why traditional approaches fail and how AI-driven solutions solve problems you didn't even know existed.
Let's dive in.
What are the Challenges of Research Compliance
Most research institutions think they understand their compliance problems. They see the symptoms: missed deadlines, last-minute scrambling for audits, protocol deviations that seem to come out of nowhere. But they're missing the root causes.
Here's what we've learned from analyzing compliance failures across hundreds of institutions:
Multiple Systems
You probably think the biggest problem is having separate systems for IRB, IACUC, IBC, RSC, CSC, SCRO, and other committees. That's only part of it. The real problem is what happens between these systems.
Research often requires approvals from multiple committees, each with its own protocol. When these systems aren't integrated, maintaining compliance across related protocols becomes a manual, error-prone process. A change in one protocol doesn't automatically reflect in related protocols that reference it. Version control and cross-referencing become nearly impossible.
For example, a researcher conducting preclinical research on animals prepares an IACUC protocol that requires the use of biological agents. In their IACUC protocol, they must reference an approved IBC protocol that details how these biological agents will be handled.
Without an integrated system: The researcher has to manually retrieve information from the separate IBC system and enter it into the IACUC protocol. If the IBC protocol is later updated with new safety procedures, the researcher may not know to update the IACUC protocol accordingly. During an inspection, auditors discover that the IACUC protocol references outdated IBC procedures, creating a compliance gap that halts research until both protocols are reconciled.
With an integrated system: When preparing the IACUC protocol, researchers can search for approved IBC protocols directly within the same system, select the appropriate one, and the system automatically fetches all relevant information. If the IBC protocol is updated, the system can flag related protocols that need review, ensuring compliance is maintained across all connected research activities.
This isn't a training problem or a researcher problem—it's a system design problem. An intelligent integrated system connects all committee requirements in one place, making it easier for researchers to prepare compliant protocols by seamlessly referencing approved protocols from other committees, while eliminating the risk of manually entering outdated information that could create compliance issues.
The Audit Preparation Reality
Most institutions prepare for audits by gathering documentation. They create binders, organize files, and hope they have everything the auditors need. This common approach is stressful and often reveals problems at the worst possible time.
Auditors want to see if your documentation tells a consistent story. They trace specific protocols from initial submission through all amendments, committee reviews, and implementation. Any gap or inconsistency raises red flags.
The most common audit failure isn't missing documents but inconsistent documents. This includes an IACUC file showing one version of a protocol, but the laboratory records show a different version. These inconsistencies exist if all your documentation does not come from a single source of truth.
This is why you need an integrated platform that maintains a single source of truth. eProtocol's integrated system ensures that when a protocol is amended, all related documentation—laboratory records, training materials, and committee files—automatically references the current version.
During audits, when auditors trace a protocol from initial submission through all amendments and implementation, they see a consistent, unified story. There are no version mismatches between what the committee approved and what's being followed in the laboratory, because all documentation pulls from the same centralized protocol record.
Training and Certification Compliance Bottleneck
Here's another common challenge in research compliance. Institutions must track training completion dates and send renewal reminders—whether researchers completed their CITI program modules, animal handling certifications, or biosafety training.
In research involving multiple team members across different protocols, managing training requirements manually becomes overwhelming. Different roles require different certifications, renewal dates vary, and keeping track of who needs what training and when creates a significant administrative burden.
An intelligent compliance platform can solve this by automating personalized training schedules based on each team member's specific roles and protocol assignments, rather than using generic one-size-fits-all approaches.
The system proactively tracks certification expiration dates and sends automated alerts before they expire, ensuring continuous compliance without manual spreadsheet tracking. More importantly, it can prevent non-compliant personnel from being assigned to protocols they're not certified to work on, detecting potential violations before they occur rather than discovering them during audits.
The Real Cost of Compliance Problems
Compliance issues create lasting damage to research institutions. Here's what actually happens when compliance breaks down:
1 Research Delays and Productivity Loss
When compliance issues are identified, research often must be paused or halted entirely until problems are resolved. Protocol reviews must be repeated, previously collected data may be invalidated, and ongoing studies face suspension. These interruptions don't just affect one project—they cascade across entire research programs. Teams lose months of work, and even after resolution, rebuilding momentum takes significant time. The productivity impact extends well beyond the immediate compliance incident.
2 Researcher Frustration and Turnover
Compliance systems that create unnecessary administrative burden drive researchers away. When talented investigators spend excessive time navigating disconnected systems, duplicating data entry, and managing preventable compliance issues, they become frustrated with the institution. Senior researchers, who have options, may choose to move to institutions with more streamlined compliance processes. The loss of experienced principal investigators affects not only current research but also mentorship, grant applications, and institutional reputation.
3 Grant Application Competitiveness
Funding agencies and review committees consider institutional compliance history when evaluating grant applications. Recent compliance violations, audit findings, or regulatory actions can raise concerns about an institution's ability to conduct research responsibly. While this isn't always a formal criterion, it influences reviewer confidence and can impact funding decisions. Institutions with strong compliance records have an advantage in competitive funding environments.
Why Now is the Time for a Modern Shift in Compliance Management
Regulatory requirements aren’t just increasing in number; they’re also becoming more interconnected. The challenge today isn’t the sheer volume of new regulations, but how they are linked across different domains.
For example:
- Human subjects protocols now intersect with biosafety regulations when involving genetic testing or biological samples.
- Radiation safety protocols now have implications for data security standards when involving medical imaging data.
- Chemical safety protocols intersect with environmental regulations and waste management requirements.
A change in one area can create ripple effects across others. Managing these interdependencies requires AI-powered integrated systems that can automatically recognize and manage these workflows.
Consider transitioning to modern platforms for enhanced compliance management and to reap the following benefits.
- Accelerated research progress: When compliance is predictable and systems are integrated, protocols move through approval more efficiently, reducing delays and enabling research to progress on schedule.
- Competitive advantage in funding: Funding agencies increasingly evaluate institutional compliance capabilities. Institutions that demonstrate efficient, reliable compliance systems position themselves more favorably during competitive grant evaluations.
- Attracting research talent: Leading researchers seek institutions with strong research support infrastructure. Institutions known for streamlined compliance processes have an advantage in recruiting top talent.
- Enabling partnerships: Industry partners and collaborating institutions prefer working with organizations that have proven compliance capabilities and efficient processes for managing complex multi-site research.
The Role of AI in Research Compliance Management
Most people think AI in compliance means automation. But it’s only a part of the overall picture. AI is here to transform the entire protocol creation, submission and approval workflow. Here's what AI actually does for research compliance at both individual and institutional levels.
Benefits to the Research Team
Let’s discuss how AI can transform how Principal Investigators and Researchers work.
Research protocols are complex documents. Human subject protections, animal care procedures, biosafety protocols, radiation safety measures, and chemical handling procedures each require specific information that must be consistent throughout the document. Researchers often spend weeks preparing submissions, only to receive clarification requests that delay approval by months.
Here's how AI transforms protocol development: AI guides protocol development, analyzes as you write, and identifies potential inconsistencies before submission.
For example, if you specify particular radiation exposure levels in the safety procedures section but reference different exposure limits in the experimental design, AI flags this immediately. If your biosafety containment level doesn't match your experimental procedures, AI alerts you before you submit the protocol. If your informed consent process doesn't align with the actual study procedures described in your IRB submission, AI identifies this discrepancy.
When your research requires referencing other approved protocols (such as referencing an IBC protocol within your IACUC submission), an integrated system allows you to search for and pull information from approved protocols directly, ensuring accuracy and reducing manual entry errors.
Result? Instead of spending 40 hours preparing a protocol and then receiving 15 clarification questions, researchers spend 25 hours preparing a protocol that receives three clarification questions, moving closer to approval on the first submission.
Every institution has unique requirements. IRB committees have different preferences for informed consent documentation. IACUC committees have different preferences for animal welfare documentation. IBC committees focus on different aspects of biosafety protocols.
Researchers spend enormous time trying to understand what each committee actually wants. Here's how AI provides contextual intelligence.
AI learns from your institution's historical approvals and rejections. It knows that your IRB committee always asks about data privacy protections when certain types of behavioral research are involved. It knows that your IBC committee requires specific documentation for genetically modified organisms. It knows that your RSC committee emphasizes particular dosimetry protocols for certain types of radiation research. It knows that your CSC committee focuses on specific waste disposal procedures for particular chemical classes. AI guides you to include this information proactively.
Result? Researchers submit protocols that align with their institution's specific requirements, dramatically reducing back-and-forth clarifications across all committee types.
Protocol information appears in multiple places throughout submissions. Human subjects recruitment numbers in the IRB submission must match statistical power calculations in the research design. Animal numbers in the experimental design must match animal numbers in the welfare assessment. Chemical quantities in the procedures section must align with waste disposal plans. Manual verification of these connections is time-consuming and error-prone.
That’s where you need AI that ensures consistency.
In this case, AI automatically cross-references all protocol sections, ensuring that information is consistent throughout the document. When you change an experimental parameter in one section, AI identifies all other sections that need corresponding updates. This way, researchers can eliminate internal inconsistencies within their own protocols across all committee requirements.
Benefits to Institution / Organization
Now, let’s understand how AI helps research institutions in increasing research productivity.
Traditional protocol review involves multiple rounds of clarifications. Committee members spend meeting time discussing unclear protocols. Researchers spend weeks responding to questions. The entire process can take 3-6 months for complex protocols.
Protocols developed using AI arrive at committees with fewer ambiguities and inconsistencies, so committee members spend less time seeking clarifications and more time evaluating scientific merit. This helps research institutions move through review processes more efficiently.
Result? Protocols move through review processes more efficiently, with fewer rounds of clarification needed before approval.
When researchers spend less time on compliance administration, they spend more time doing actual research. This isn't just about individual productivity—it's also about institutional research capacity.
Here's how AI increases research capacity:
Every hour saved on protocol preparation is an hour available for research activities. When approval cycles are faster, researchers can initiate studies sooner and complete more studies per year. When compliance is predictable, researchers can plan research timelines more accurately.
This way, the same research staff can complete more studies per year, and institutions can take on more research projects without hiring additional personnel.
Most institutions don't understand where their approval processes break down. They know average approval times, but they don't know why some protocols take longer than others or which factors predict approval delays.
Here's how AI enables process optimization:
AI analyzes approval patterns across all protocols and committees. It identifies which types of protocols consistently face delays, which committee members provide the most helpful feedback, and which submission factors predict smooth approvals. This data enables targeted process improvements.
This way, research institutions can optimize committee compositions, adjust review processes, and provide targeted guidance to researchers.
Research institutions often struggle with resource planning. AI enables predictive planning by analyzing submission patterns and predicting future workloads. It can forecast that IACUC or IRB submissions will increase based on grant award patterns. It can predict which protocols will require full committee review versus expedited review.
This way, institutions can adjust committee meeting schedules, allocate reviewer resources, and manage workloads proactively, preventing bottlenecks before they occur.
Additional Strategic Benefits
1 Stronger Institutional Reputation
Institutions with efficient compliance processes enable researchers to complete studies on time, avoiding delays that could otherwise derail progress. This efficiency helps build a reputation for research excellence and operational efficiency. Institutions known for supporting researchers effectively attract top talent, which in turn leads to higher-quality research outcomes. This solid reputation becomes a competitive edge when it comes to attracting both researchers and funding.
2 Higher Success in Securing Research Funding
Funding agencies increasingly assess institutional capabilities in addition to research proposals. Institutions with streamlined research operations and proven compliance systems are at a distinct advantage during funding evaluations. Efficient compliance signals reliability, making these institutions more attractive for competitive grants.
3 Attracting Top Research Talent
Leading researchers seek institutions with strong research support systems. Institutions with smooth, predictable compliance processes stand out to top talent, making them more likely to choose your institution over others. This helps bring in researchers who can drive impactful, high-quality studies.
4 Expanded Research Opportunities
Efficient compliance management allows institutions to take on a broader range of research projects, including complex, multi-investigator studies. This opens doors to new industry partnerships and ambitious research initiatives that were previously out of reach. Larger, more diverse projects bring more significant discoveries, enhancing the institution's impact and prestige.
In Short, AI Enables the Following Transformation:
- Instead of responding to compliance problems, institutions prevent them
- Instead of managing compliance, institutions leverage compliance for competitive advantage
- Instead of minimizing compliance costs, institutions maximize compliance value
Institutions that master AI-driven compliance can outperform competitors in research productivity, funding success, and talent attraction.
How Key Solutions Revolutionizes Research Compliance Management
Most compliance software try to digitize existing processes. Key Solutions technological solutions redesign compliance from the ground up. Here's how eProtocol with AI-enhanced services solves the problems other systems can't address.
Unified Platform for Seamless Multi-Committee Management
The fundamental problem with traditional compliance management is fragmentation. As researchers use different systems for different activities, information gets trapped in silos, and coordination becomes a manual nightmare. However, our eProtocol platform eliminates fragmentation entirely.
How unified management actually works:
- Single source of truth: Every piece of information about a protocol exists in one place. This means when something changes, it changes everywhere automatically, so that you can eliminate inconsistencies and version control problems.
- Integrated workflows: Easily manage multiple protocols across committees without needing to switch between platforms. For example, when drafting an IACUC protocol that involves biological agents, you can instantly search and reference approved IBC protocols directly within the system, ensuring proper biosafety compliance without leaving your workflow.
- Unified reporting: All committee activities appear in integrated dashboards. You can see the complete status of any protocol across all committees from a single screen.
Let's say a researcher is working on a study involving human subjects, radioactive tracers, genetically modified cell lines, and hazardous chemicals. This requires creating four separate protocols for IRB, RSC, IBC, and CSC approval.
In traditional systems, this means managing these protocols across four different platforms, checking multiple systems for status updates, and manually tracking approvals in disconnected environments.
However, with eProtocol, while you still create the four distinct protocols required by each committee, you manage them all within a single unified system. You can view the status of all four protocols from one dashboard, track their progress across committees in real-time, and receive consolidated notifications—all without switching between different platforms.
As said earlier, when your IACUC protocol references biological agents, for instance, you can quickly search and link to your approved IBC protocol directly within the same system, ensuring seamless cross-referencing and compliance tracking.
Intelligent Workflow Automation and Administrative Relief
The automation speeds up existing processes and eliminates unnecessary processes entirely.
How intelligent automation works:
- Smart form completion: The system learns from previous submissions and pre-populates forms with likely information. Researchers spend minutes, not hours, on routine submissions.
- Automatic routing: The system facilitates the routing of documents to internal managers or reviewers.
- Intelligent scheduling: Committee meetings are automatically scheduled based on submission patterns, reviewer availability, and protocol complexity. The system optimizes schedules to minimize delays.
- Proactive notifications: Instead of generic reminders, the system sends specific, actionable notifications. "Your protocol amendment needs one more signature," instead of "You have pending items."
- Adaptive workflows: The system adjusts workflows based on protocol complexity and risk level. Simple amendments follow fast-track processes. Complex protocols get additional review steps automatically.
Here are a few specific automation examples.
- Meeting management: The system automatically generates meeting agendas based on submission deadlines and protocol complexity. It schedules meetings to optimize reviewer workload and minimize protocol delays. Meeting minutes are automatically generated from reviewer comments and decisions.
- Document routing: The drafted protocol can be routed to institutional managers for review before sending it to the committee boards like IRB, IACUC, etc.
- Amendment processing: The system automatically categorizes amendments by significance and routes them through appropriate review processes.
The major goal here is to automate work and eliminate unnecessary work. When systems are intelligent enough to handle routine decisions, humans can focus on complex judgments across all research domains.
Advanced Predictive Risk Management
Traditional compliance management is reactive, where you discover problems after they happen. However, Key Solutions makes compliance management predictive. Here’s how:
- Protocol deviation prediction: The system identifies protocols with high deviation risk based on complexity, personnel changes, and historical patterns. It recommends specific monitoring and support measures to prevent deviations.
- Committee delay prediction: The system predicts which protocols are likely to face committee delays based on submission timing, complexity, and reviewer workload. It recommends submission timing adjustments and reviewer assignments to minimize delays.
- Training gap prediction: The system identifies individuals who are likely to have compliance issues based on training history, role changes, and performance patterns. It recommends targeted training and support interventions.
- Audit risk prediction: The system identifies areas of highest audit risk based on recent activity patterns and regulatory focus areas. It recommends proactive documentation and process improvements.
For example, the system identifies that protocols involving both human subjects and radioactive materials have higher deviation rates when assigned to researchers with limited radiation safety experience. It automatically flags these protocols for additional oversight and recommends specific training modules for the assigned researchers. This prevents deviations before they occur across multiple compliance domains.
Comprehensive Documentation and Audit-Readiness
Research institutions prepare for audits by gathering documentation, but with eProtocol, they can be audit-ready every day. How comprehensive documentation works:
- Automatic audit trails: Every action in the system is automatically logged with timestamps, user identification, and context. Complete audit trails are maintained without any manual effort.
- Automated report generation: The system automatically generates compliance reports in formats required by different regulatory agencies. Reports are always current and complete.
- Complete protocol histories: Every protocol has a complete, automatically maintained history showing all submissions, reviews, approvals, amendments, and implementations. This history is immediately available to auditors in any format they require.
- Cross-reference verification: The system automatically verifies that all cross-references between documents are accurate and current. Inconsistencies are flagged and corrected before audits.
- Regulatory compliance tracking: The system tracks compliance with all applicable regulations and provides real-time status reports. Any compliance gaps are immediately identified and addressed.
- Training documentation: The system maintains complete training records for all personnel, including competency assessments and performance tracking, so that the training compliance is continuously verified.
In short, with eProtocol, you can maintain audit-ready documentation and provide complete documentation for any requested protocol within minutes.
Integration Capabilities That Transform Operations
eProtocol not only lets research firms manage compliance, but also integrates compliance with all other research operations. Here’s how:
- LIMS/ELN integration: The system integrates with laboratory information management systems (LIMS) and Electronic Notebooks (ELN) to ensure that laboratory procedures match approved protocols. Any discrepancies are immediately flagged.
- Financial system integration: The system integrates with financial systems to track research expenditures against approved budgets and ensure that spending aligns with protocol requirements.
- Training systems integration: The system integrates with training systems (AALAS, CITI, Institutional records) to verify that all personnel working on protocols have current training and certifications.
- Facility management integration: The system integrates with facility management systems to ensure that laboratory spaces and equipment meet protocol requirements.
When compliance systems integrate with operational systems, both become more effective.
Your Next Steps: Managing Your Compliance With Ease
The question for research institutions today is not whether to modernize compliance management, but rather how quickly they can leverage systems and tools that will help them in the ever-changing compliance landscape.
Research teams need to ask themselves: How can we leverage compliance systems to accelerate innovation rather than hinder it? This is the mindset shift that AI and automation bring to the table, turning compliance burden into a strategic advantage.
And Key Solutions as Your Partner in Compliance Transformation
Key Solutions stands as your dedicated partner in this transformation. We have been offering comprehensive software solutions tailored for life sciences research institutions. With over two decades of experience, we provide integrated, web-based platforms that help with:
- Research Compliance: Manage protocols across IRB, IACUC, IBC, RSC, CSC, SCRO, and more.
- Animal Resource Management: Streamline animal care and facility operations.
Research Administration: Manage grants management, conflict of interest disclosures, and post-award grant management.
- AI/ML and Data Analytics: Build tailored solutions or extend platform capabilities with advanced analytics and machine learning leveraging our professional and consulting services.
Whether you need customized platform implementation, data migration, or strategic consulting, our team is here to support you in optimizing your workflows and integrating your compliance processes effectively.
Want to know more? Reach out to us here, and one of our experts will contact you right away.
Frequently Asked Questions
Research compliance management refers to the process of ensuring that all research activities meet regulatory and institutional standards. This includes obtaining necessary approvals from committees like IRB, IACUC, and IBC, maintaining documentation, tracking compliance activities, and preparing for audits. Effective compliance management ensures that research is conducted ethically and legally, protecting both participants and researchers.
Research compliance is crucial to ensure that studies are conducted according to ethical standards, safeguard participants' rights, and adhere to legal requirements. Non-compliance can result in legal repercussions, loss of funding, and, in some cases, suspension of research. Adhering to compliance standards also enhances the credibility of research findings, ensuring that results are trustworthy and reproducible.
To manage research compliance efficiently, you need an integrated solution that centralizes all compliance-related activities. Key Solutions eProtocol software provides a unified platform where all regulatory committee tasks are managed in one place.
Managing research compliance comes with its own set of challenges, such as:
- Fragmented systems
- Overwhelming paperwork
- Protocol deviations
- Training compliance
- Audit stress
eProtocol is Key Solutions' comprehensive, AI-driven software platform designed to streamline research compliance across various committees like IRB, IACUC, IBC, SCRO, and others. It centralizes all compliance activities, from protocol submissions to audits, into one integrated, paperless system. It simplifies workflows, improves data accuracy, and provides real-time insights into compliance status, helping research institutions stay audit-ready and reduce the administrative burden.
AI plays a crucial role in transforming traditional compliance management into a proactive, efficient system. With AI-powered tools like predictive analytics, Principal Investigators (PIs) or compliance officers can forecast potential risks, such as protocol deviations or missed compliance deadlines, allowing teams to address issues before they escalate. AI automates routine tasks, optimizes workflows, and ensures that compliance processes are more accurate and efficient.
- Predictive Risk Management: AI identifies patterns in historical data, anticipating compliance risks before they impact research progress.
- Automated Document Review: AI streamlines the review process by identifying missing information or discrepancies, ensuring error-free submissions.
- Real-Time Compliance Monitoring: AI provides real-time updates and alerts about protocol amendments, approval statuses, and upcoming deadlines, helping research teams stay on top of compliance.
eProtocol supports a wide range of regulatory committees, including:
- IRB (Institutional Review Board) for human subjects research
- IACUC (Institutional Animal Care and Use Committee) for animal research
- IBC (Institutional Biosafety Committee) for biosafety research
- SCRO (Stem Cell Research Oversight) for stem cell research
- RSC (Radiation Safety Committee) for radiation research
- CSC (Chemical Safety Committee) for handling hazardous chemicals
- CS (Controlled Substances Committee) for controlled substance research
eProtocol automates the creation and management of compliance documents, including tracking approvals, amendments, and protocol deviations. With built-in audit trails and real-time document tracking, eProtocol ensures that your institution is always prepared for inspections or audits. The system automatically logs every action and decision, making it easier to provide comprehensive, accurate documentation at a moment's notice.
Yes. Whether you’re a small specialty research center or a large multi-institutional network, eProtocol is designed to scale with your institution's needs. The platform's configurable architecture and customizable workflows ensure that eProtocol adapts to your specific research and compliance processes.
eProtocol with AI-enhanced service, uses predictive analytics to identify patterns that might indicate future protocol deviations, such as delays or non-compliance in previous studies. For example, suppose an IACUC protocol has a history of delayed approvals or missing documents. In that case, the system will flag this and notify the team before issues arise, ensuring research is not delayed.
AI-powered document review in eProtocol ensures that compliance documents, such as protocol submissions and consent forms, are automatically scanned for errors, inconsistencies, or missing elements. Using Natural Language Processing (NLP), eProtocol checks for adherence to regulatory guidelines and ensures documents meet the required standards before they reach committee members for approval.
eProtocol with AI-enhanced service automates the tracking of training and certification compliance for your research team. The system can automatically generate personalized training schedules based on team members' roles and responsibilities. It sends alerts when certifications are about to expire, ensuring that researchers and coordinators maintain the required certifications without missing a deadline.
eProtocol is built for research institutions conducting studies that require oversight from regulatory committees. Whether it’s animal research (IACUC), human subjects research (IRB), or other compliance areas, eProtocol helps manage protocol submissions, reviews, approvals, training, audits, and deviations — all in one streamlined system.
eProtocol integrates seamlessly with research systems like LIMS, ELN, AALAS, CITI, CTMS, and institutional Finance and HR platforms to streamline workflows and reduce manual data entry. These integrations eliminate data silos, improve consistency, and enhance operational efficiency across research compliance processes.
Key Solutions stands out for its deep domain expertise in life sciences research and its focus on AI-powered research compliance. eProtocol is more than just software — it’s a comprehensive solution built to streamline workflows, reduce administrative burden, and support end-to-end compliance. In addition to our platform, we offer professional services that go beyond implementation — helping institutions build customized AI/ML and Data Analytics solutions tailored to their unique research and compliance needs.
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