5 Compliance Challenges in Healthcare Research

In today’s healthcare research landscape, organizations face more pressure than ever to remain compliant with evolving regulations. The stakes of maintaining compliance are often high, as non-compliance can delay research, jeopardize funding, and result in reputational damage to both individuals and entire organizations. 

Despite these risks, many teams still rely on outdated manual processes or piecemeal systems to manage compliance. While leadership may be hesitant to change the status quo, outdated compliance management practices are unfortunately prone to user confusion, data errors, and organizational silos. 

However, with the right modern management solution in place, compliance can go from a headache to a strategic advantage. Below, we’ve outlined five common compliance challenges in healthcare research—and how technology and software solutions can help resolve them.

1. Fragmented Documentation

Challenge: Compliance records are often scattered across spreadsheets, email chains, paper files, and other disconnected systems. This makes it difficult to maintain version control, track updates, and ensure accuracy, with few ways to enforce a single source of truth and significant risks of losing essential data to staff turnover, poor file management, and even the transition from physical to digital formats.

Solution: A centralized, cloud-based platform creates a reliable, centralized repository for all compliance-related documentation. Teams can quickly access the most up-to-date records and make changes with consistent documentation, reducing errors and improving accountability.

2. Manual Processes and Human Error

Challenge: Paper-based submissions, manual approvals, and siloed workflows often slow down compliance approvals and leave room for mistakes. Even small errors, such as a missed email, can create costly delays.

Solution: Automated workflows and built-in checks and balances found in modern compliance software ensure accurate data input/output and keep processes moving in the right direction. By eliminating repetitive manual tasks such as email follow-ups and manual data entry, staff can focus on higher-value work and spend less time checking for errors, missed reviews, and approvals. 

3. Lack of Transparency Across Teams

Challenge: Compliance issues often surface when stakeholders lack clear visibility into the status of submissions, revisions, or approvals, creating uncertainty and risks when audits arise or deadlines approach. A lack of transparency increases the frequency of delays and errors, and can even cause unwanted mistrust and frustration across teams.

Solution: Software with real-time status views and role-based access to information provides visibility across departments, significantly increasing transparency. This gives all relevant stakeholders access to key information, requests, and upcoming deadlines, improving collaboration and accountability across teams and the organization as a whole.

4. Audit Stress and Limited Preparedness

Challenge: When audit time arrives, no team wants to scramble to gather the required documentation from multiple unconnected systems. This can create unnecessary stress and even increase the risk of missing details, introducing errors, and exceeding submission deadlines.

Solution: Automated audit trails and centralized records ensure all documentation is complete, accurate, and easy to provide when required. With the right solution and workflows in place, audit-readiness becomes the norm, not the exception.

5. Complex Review Processes

Challenge: IRB, IACUC, and IBC submissions often require multiple revisions, signatures, and back-and-forth communication. Without a set, approved workflow, bottlenecks often arise, leading to overlong review periods and introducing unnecessary noncompliance risks.

Solution: Online submission and review platforms, such as iRIS Risk & Compliance,  streamline complex review workflows and help mitigate risk. By automating notifications, tracking revisions, and simplifying communications, organizations can reduce review times and improve compliance outcomes.

Turning Compliance Into a Strategic Advantage

Compliance in healthcare research will always be complicated, but it doesn’t need to be chaotic. By adopting connected, cloud-based solutions like Cayuse Compliance Management, organizations can reduce risk, improve transparency, and simplify compliance processes from start to finish.

When compliance is well-managed and efficient, research organizations don’t need to spend time chasing paperwork or submitting revision requests. Instead, their staff can focus their efforts on increasing research success and participating in the work that matters most: advancing discovery, improving healthcare, and changing lives.