Strategic Questions Every VP of Research Must Ask Before Selecting Compliance Software

The research compliance software decision you make today will impact your institution's research capacity, regulatory standing, and competitive position for years to come. Yet most selection processes focus on features rather than strategic outcomes. 

As a VP of Research, your primary concerns are not just whether a system can route protocols or generate reports, but you are accountable for greater responsibilities, such as: 

• Institutional risk management
• Regulatory compliance across multiple oversight bodies; Staying ahead of rapidly changing regulations and technology advancements.
• Strategic positioning of your research enterprise: Finding ways to streamline compliance and administrative processes to allow researchers more time for their work.
• Research portfolio growth; Ensuring that the research community has access to state-of-the-art facilities and resources.
• Attracting and retaining top-tier research talent in a competitive market.
• Balancing administrative duties with the desire to remain involved in active research.

Here's why the research compliance platform you choose should accelerate these objectives. The following strategic considerations will help you evaluate vendors not just on what their software can do, but also on how their platform aligns with your institutional priorities and long-term research strategy.

Let's dive in. 

1. Institutional Risk Management & Regulatory Protection

The following questions will help you understand how to safeguard your research processes and ensure compliance across the institution. These are crucial to ensure your institution stays protected from compliance risks and can maintain operational efficiency.

• How does your platform minimize compliance risks that could impact our institution's standing?
  Look for features that help prevent risks, such as ensuring all applicable regulatory requirements are demonstrably addressed and maintaining robust revision controls and audit trails that can stand up to inspections.
  
• What level of institutional visibility does your platform offer into compliance across all research activities?
  To ensure comprehensive oversight, your platform must provide visibility into compliance across committees. With real-time dashboards, leadership can be immediately alerted to potential compliance issues, allowing for proactive resolution before they escalate. 

The system should integrate all compliance safety committees, consolidating data and ensuring policies are consistently enforced across the board. Automated processes and robust audit capabilities further reinforce your institution’s commitment to maintaining the highest regulatory standards, making compliance both efficient and transparent.

• How does your platform provide a single, unified system for managing research compliance across the institution?
  A centralized platform should offer visibility into the work of various research committees while providing an intuitive, common interface that simplifies tasks for researchers, review committee members, and coordinators. The system should be easy to navigate, minimizing the need for extensive training and allowing users to focus on their work instead of managing complex workflows.
  
• How does your platform enable seamless integration and data sharing across research compliance, lab animal facilities, lab animal health, financial, and HR systems?
  Make sure you ask this question as efficient integration between different systems, combined with single sign-on capabilities: 
  
  • Ensures smooth data flow across multiple departments
  • Streamlines workflows
  • Improves accuracy
    
• How does your platform ensure data security and protection?
  All research compliance data must be stored securely, with built-in protections that comply with industry standards and regulations, such as GDPR and SOC 2, to safeguard sensitive information and maintain trust across all stakeholders.

2. Strategic Scalability & Future Growth

The following questions will help you assess how your platform can scale and support future growth while maintaining operational efficiency. These questions are essential to ensure your institution can expand seamlessly without compromising performance or compliance.

• How will your platform accommodate our research expansion into new domains without requiring system redesign?
  Look for platforms that can scale beyond just user capacity. As your research grows, the platform should seamlessly incorporate new research areas, oversight committees, and evolving institutional structures without needing major reconfigurations.
  
• What’s your track record supporting institutions through significant research portfolio expansion?
  Request real examples of how the platform has supported other institutions during periods of rapid growth. Whether it’s the addition of new research domains, increased collaboration complexity, or evolving structures, you want to ensure the platform can handle these changes.
  
• How does your platform's performance scale with our growing research activities?
  Ask for guarantees about the platform’s ability to perform as your research load increases. You’ll want clear SLAs for uptime, response times, and support during high-demand periods. 

3. Total Cost of Ownership & Financial Strategy

While the initial licensing cost of research compliance software may seem like the primary expense, it’s only a small part of the total investment required for full implementation and ongoing operations. The following questions will help you understand the full financial implications of your platform selection, ensuring that you can make an informed decision that aligns with your institution's long-term financial strategy.

• What are the complete costs associated with achieving full operational capability on your platform?
  Look for a clear breakdown of costs beyond just licensing. This should include implementation, customization, integration, training, and ongoing support costs.
  
• How do ongoing operational costs compare to the value generated through improved compliance efficiency?
  Request examples of ROI from similar institutions. Specifically, look for metrics around reduced administrative overhead, better audit outcomes, and increased research productivity.‍
• What costs should we anticipate for platform evolution as our institutional needs change?
  This will help you gauge whether the platform evolves with your institution or requires costly customization.

4. Vendor Partnership & Long-term Reliability

Research compliance software represents a long-term commitment, and its value extends far beyond the initial purchase decision. It's crucial to choose a vendor who will be a reliable partner as your institution grows and faces new challenges.

The following questions will help you assess whether the vendor can offer the strategic partnership necessary for long-term success, ensuring that your compliance processes remain seamless and adaptable over time.

Strategic Questions to Ask:

1. What expertise does your organization bring to research compliance beyond software development?
   Look for vendors with extensive experience in research compliance who can offer more than just technical support. You need a partner who can guide you through complex regulatory landscapes and provide strategic insight during challenging situations.
   
2. How do you support institutions during regulatory changes that require immediate platform updates?
   This question will help you determine if the vendor is a true strategic partner during critical times or if they leave you to manage compliance challenges independently.
   
3. What’s your development roadmap for incorporating future regulatory requirements and emerging technologies like AI/ML?
   Ask this to understand whether the vendor stays ahead of the curve with emerging trends and regulatory shifts. 

5. Integration & Institutional Ecosystem

Modern research institutions rely on a complex web of technologies that must function together seamlessly. To support research productivity while ensuring compliance, these systems need to integrate efficiently. The following questions will help you understand how the software can be integrated with your institution's existing technology ecosystem.

• How does protocol information flow between your compliance system and our financial management platforms for grant administration?
  Look for platforms that connect compliance and financial systems at critical stages: during the pre-award phase to ensure projected compensation in grant proposals aligns with actual financial data, and during post-award management to enable accurate financial reporting. While funding sources are typically added directly to protocol information at creation, robust financial system integration ensures your proposals are built on realistic numbers and your post-award reporting maintains accuracy and compliance throughout the grant lifecycle.
  
• What institutional efficiencies can we expect through integrated system capabilities?
  Check if the platform automates compliance processes, freeing up time for researchers to focus on their work. Integrated systems should help reduce administrative burden, improve coordination across departments,  decrease training times, and ensure that compliance is maintained.
  
• How will your platform connect with our existing technology infrastructure without requiring system replacement?
  The platform should seamlessly integrate with your existing infrastructure. Ensure that the vendor has experience with institutional integration projects, allowing for a smooth transition without the need for expensive system replacements or complex overhauls.

6. Competitive Advantage & Strategic Positioning

Your compliance platform should not only support compliance but also give your institution a competitive edge in securing funding, attracting top research talent, and maintaining a strong regulatory position. The following questions will help you assess how the platform can support your institution’s strategic goals and enhance its competitive position.

Strategic Questions to Ask:

• How does your platform enhance our institution's competitive position in securing research funding?
  Look for platforms that streamline grant application processes, improve compliance documentation for funding applications, and demonstrate a strong commitment to regulatory excellence. A platform that makes grant submissions easier and faster can significantly improve your chances of securing funding.
  
• What competitive advantages do institutions gain through your platform's advanced capabilities?
  Seek platforms that offer advanced features like AI/ML automation, predictive compliance monitoring, and analytics. These capabilities can help accelerate research timelines, foster stronger relationships with regulators, and improve overall research efficiency, giving your institution a competitive edge.
  
• How does your platform support our ability to attract and retain top research talent?
  Researchers prefer institutions with streamlined, efficient compliance processes that support their scientific goals. Look for platforms that automate manual compliance tasks, reduce administrative overhead, and create a smooth, predictable research environment, making it easier for researchers to focus on their work and contributing to talent retention.

Key Solutions Product Suite: Your Strategic Partner in Research Compliance & Administration 

As we’ve discussed, selecting the right research compliance platform is critical to your institution’s ability to grow, stay compliant, and maintain a competitive edge. The platform you choose should help streamline your compliance management and reduce the burden.

The Key Solutions product suite is designed to do exactly that. Key Solutions offers: 

• Research Compliance Suite: Manage protocols across IRB, IACUC, IBC, RSC, CSC, SCRO, and more with the eProtocol platform.
• Animal Resource Management Suite: Streamline animal care and facility operations with LARS and LAHS. Use LARS to manage animal procurement, billing, and facility management. Use LAHS to manage animal care and management.
• Research Administration Suite: Manage grants management, conflict of interest disclosures, and post-award grant management with eGrants and eCOI.
• AI/ML and Data Analytics:  Build tailored solutions or extend platform capabilities with advanced analytics and machine learning, leveraging our professional and consulting services.

Here’s how the Key Solutions product suite can support your research compliance needs.

1. Seamless Integration with Your Existing Systems‍

Research institutions often operate with a variety of systems for financial management, HR, and compliance oversight. Key Solution products with customized services ensure that all these systems work together smoothly in your environment.. 

For example, when a protocol is approved by your IRB, the system automatically updates the financial management system, such as grant management or ERP, triggering the activation of the funding account or cost center. Without IRB approval, the account remains locked or pending. 

This integration ensures that compliance is maintained automatically, and there’s no need for manual entry to keep systems aligned. 

Additionally, if IRB approval lapses (e.g., renewal is not submitted), the system can automatically freeze the funding account and notify finance and compliance teams to halt new expenditures, ensuring ongoing compliance with minimal administrative effort.

2. Reducing Administrative Overhead with Smart Forms & Automations

Administrative tasks can quickly pile up, and in research compliance, they often slow down the entire process. However, the eGrants products reduce that burden through automation. 

For instance, when submitting an IRB protocol, the platform uses smart forms to ensure questions that need to be answered are presented and checked, and those that don’t need to be presented. This helps researchers focus on the important items and reduces the chance of errors. Additionally, tasks like tracking protocol amendments or scheduling committee reviews are automated, freeing up your compliance teams to focus on higher-level tasks.

3. Staying Compliant with Dynamic, Automatic Updates

Regulatory requirements for research compliance, such as those for IRB, IACUC, and IBC, are indeed constantly evolving. That’s why eProtocol helps institutions stay compliant by offering flexibility to integrate new regulatory requirements as they arise quickly. 

For instance, when new regulations are introduced, your compliance team can manually update the system, and eProtocol will ensure that those updates are consistently applied across all protocols, workflows, and committee processes. This feature reduces the time needed to adjust compliance processes and ensures your institution is audit-ready with up-to-date documentation.

Also, you can maintain detailed audit trails and real-time updates on protocol statuses. This reduces the risk of non-compliance and makes it easier during inspections. 

4. Predictive Insights to Prevent Compliance Issues

Rather than reacting to compliance issues, eProtocol with customized services helps your institution stay ahead of potential problems. Our platform’s AI capabilities analyze patterns across your research protocols and can flag potential risks before they escalate. 

For example, if the system detects that protocols from a specific department consistently experience delays during IRB review due to incomplete adverse event reporting procedures, it will proactively alert new submissions from that department to strengthen those sections before review. 

Similarly, if historical data shows that protocols with certain study designs frequently require modifications during the approval process, the system flags these patterns early, helping your team address potential issues upfront. By predicting bottlenecks or identifying areas at risk of protocol deviation based on institutional patterns, we help you manage compliance risks before they turn into real problems.

5. Helping You Scale with Ease

As your research portfolio grows, so do your compliance needs. eProtocol is built to scale alongside your institution. Whether you’re expanding into new research areas or adding more oversight committees, our platform adapts without requiring a system redesign. 

For example, if you’re introducing a new stem cell research program, eProtocol can seamlessly add SCRO oversight into your existing compliance workflow, ensuring consistency and reducing the need for extensive customization or additional significant training.

6. Unified System for Compliance Committee Visibility

Managing compliance across multiple committees (IRB, IACUC, IBC, etc.) can be challenging, especially when using disparate systems. However, eProtocol eliminates this complexity by providing a unified platform for all committees. 

For example, if the IBC committee flags a change to a protocol that also requires an update to the IACUC protocol, the system can alert the Principal Investigator (PI), ensuring they are aware of the update to the IBC protocol and the need for the update to the IACUC protocol. 

By providing visibility across different compliance committees, the system helps ensure that all parties are informed and that approval processes are not delayed. This centralized approach improves oversight, reduces the risk of errors, and streamlines the protocol review process, allowing research to proceed smoothly without unnecessary delays.

In short, eProtocol is not just about managing compliance; it’s about streamlining your processes, boosting productivity, and allowing your institution to focus on the most important goal: advancing research.

By integrating with your existing systems, automating routine tasks, keeping you up to date with changing regulations, and offering predictive insights, eProtocol helps make compliance easier, faster, and more efficient.