10 challenges CROs face today (and how to solve them)

Aaron Hoare Date published: Mar 24, 25

Contract research organizations (CROs) play an integral role in accelerating the development of life-saving therapies and driving innovation in the pharmaceutical, biotechnology and medical device industries. These organizations must juggle strict regulatory demands, client expectations, technological advancements and operational complexities – often all at once. 

This article outlines ten of the most pressing challenges faced by CROs today and provides brief, actionable insights into how to tackle them. Equipped with advanced technologies, such as Ideagen solutions, CROs can address these issues and lead the way in efficient, compliant and innovation-driven research. 

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1. Navigating regulatory compliance  

The challenge  

Regulatory requirements are continually evolving, differing across regions and raising the stakes for compliance. Even minor oversights can lead to costly fines, project delays and reputational damage.  

The solution  

CROs can leverage software tools designed for real-time monitoring of compliance standards. Features like alerts, audit trails and workflow automation help ensure nothing slips through the cracks. Platforms like Ideagen Quality Management streamline regulatory processes, reducing human error and freeing up time for strategic work. 

2. Reducing protocol deviations  

The challenge  

Clinical trials demand strict adherence to protocols, yet deviations remain common – impacting data integrity, timelines and even patient safety.  

The solution  

Real-time monitoring systems and AI-powered analytics can flag potential deviations before they escalate. These tools unify trial oversight and improve communication between teams, ensuring everyone is aligned with the study protocol. 

3. Ensuring data accuracy  

The challenge  

CROs handle massive datasets in clinical research, yet minor inaccuracies can undermine the credibility of results.  

The solution  

Implementing real-time data validation and centralized data systems mitigates errors. Solutions like those offered by Ideagen focus on improving real-time data accuracy, ensuring datasets remain clean and actionable across the research lifecycle.  

4. Addressing talent shortages  

The challenge  

The CRO industry continues to face staffing shortages – particularly when it comes to trained staff capable of navigating the complexities of research workflows. 

The solution  

Invest in intelligent resource management tools to efficiently allocate existing expertise. Additionally, prioritize employee engagement and development through training platforms integrated with the latest industry advancements. Technology that streamlines administrative tasks can enable CROs to make the most of their current workforce. 

5. Navigating IT governance  

The challenge  

The rapid adoption of new technologies introduces governance risks, particularly where disconnected systems and ad-hoc workflows are concerned.  

The solution  

A robust IT governance framework ensures that technology investments align with enterprise goals, regulatory standards and business priorities. Seeking guidance from seasoned experts is often a more efficient and cost-effective alternative to building in-house expertise from scratch – it is well worth exploring this option with Ideagen before addressing this complex area.  

6. Maintaining compliance across jurisdictions  

The challenge  

Global operations mean navigating diverse regulations and cultural nuances, increasing the risk of non-compliance.  

The solution  

Use jurisdiction-specific compliance trackers to stay on top of shifting regulations in real time. Cloud-based tools ensure accessibility and compliance consistency across borders. 

7. Optimizing operational efficiency  

The challenge  

Organizations often struggle with fragmented workflows and delays caused by inefficient processes.  

The solution  

Workflow automation, integrated project management tools and resource allocation platforms are essential. These tools can help CROs improve team productivity, reduce costs and keep projects on track from inception to delivery. 

8. Protecting sensitive data  

The challenge  

With large volumes of sensitive data, CROs have become an attractive target for cyber threats. A single data breach can have severe financial and reputational consequences. 

The solution  

Platforms with advanced security measures provide end-to-end encryption and proactive monitoring. Tools like those offered by Ideagen ensure that sensitive information is stored securely and accessed only by authorized personnel. 

9. Strengthening collaboration  

The challenge  

Global research teams often face communication bottlenecks and misaligned goals, impacting the collective effort required to move trials forward.  

The solution  

Adopting centralized collaboration platforms that facilitate real-time updates, shared notes and seamless communication can bridge these gaps. Collaborative technology aligns stakeholders across functions and locations. 

10. Managing cybersecurity costs  

The challenge  

Investing in advanced cybersecurity measures can strain budgets, especially for smaller CROs.  

The solution  

Cloud-based platforms with built-in security measures, like Ideagen solutions, provide scalable and cost-effective cyber defense. Consulting with established expertise is also often a more cost and time-effective approach compared to establishing in-house expertise.  

Turning challenges into opportunities for CROs 

CROs today face challenges that require sophisticated tools, agile processes and expert insight to overcome. Regulatory compliance, data accuracy and operational productivity cannot be fully realized with outdated methods. 

Technology is the key to transforming these challenges into opportunities for growth and success. Ideagen’s solutions, with their focus on real-time compliance monitoring, streamlined workflows and data accuracy, give CROs the edge they need to remain competitive and deliver exceptional value to their clients. 

Take the next step in overcoming these challenges – explore how Ideagen tools can revolutionize your operations. 

Want to see how Ideagen can help your contract research organization to tackle these challenges?

Get in contact with our team of experts today and tell us what the most pressing challenges are that your organization is facing.

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