Navigating the high-stakes world of clinical trial documentation

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Every document serves a critical purpose including patient-facing materials that drive recruitment to regulatory documentation that ensures compliance. The stakes are particularly high in today's clinical research environment, where competition for patients is intense and regulatory requirements continue to evolve. A single documentation error can compromise data integrity, patient safety, and ultimately, your study's success.

For procurement professionals, selecting the right print partner is crucial. The wrong choice can lead to: 

• Trial delays and budget overruns: When critical documents contain errors or arrive late, your timeline suffers. Each delay in a clinical trial can cost approximately $40,000 per day. These "minor" print issues can quickly become major financial burdens. 
• Compliance risks: Documentation errors can trigger regulatory scrutiny, resulting in potential fines and damage to your organisation's reputation, potentially affecting future study approvals. 
• Data security vulnerabilities: Clinical documentation contains sensitive information about patients, investigational products, and proprietary protocols. Without proper security measures, you risk GDPR breaches and intellectual property exposure. 

In an increasingly digital world, the security of physical documents is often overlooked. Yet printed materials can remain a common vector for data breaches when handled by vendors without proper security protocols and training.

Clinical trial print projects involve unique complexities that general print vendors often struggle to manage:

• Multiple languages and regions: Materials require precise translation while maintaining perfect version control 
• Version control and amendments: Each protocol change triggers a cascade of documentation updates 
• Site-specific requirements: Materials must be accurately matched to each location's needs 

As Rob White, Business Development Director at Greens, explains: "Version control of the documents is paramount, with protocol amendments a regular challenge, which means certain forms or materials will need to be updated and sent to sites. This process needs to be carefully managed."

When evaluating potential partners, look beyond basic capabilities to find these effective essential qualities: 

• Vendor selection and management: The right partner demonstrates industry expertise and financial stability. They understand the pharmaceutical industry, clinical trial regulations, and provide dedicated support with experienced account teams.  
• Cost control and efficiency: A truly valuable partner offers competitive pricing with transparent cost breakdowns and proactively identifies cost-saving opportunities. They provide solutions for optimising inventory, minimising waste, and reducing storage costs, with streamlined processes for efficient production, packaging, and distribution. 
• Risk management and compliance: Your print partner should establish robust security protocols with ISO certifications, secure facilities, and comprehensive data protection policies. They should have specific measures to protect sensitive data, clear recall procedures, and a disaster recovery plan to ensure business continuity. 
• Performance monitoring and evaluation: The best partners enable transparency with real-time tracking, inventory management tools, and documentation history.  

Beyond these foundational qualities, leading clinical print partners also demonstrate an ongoing commitment to innovation and process improvement. The landscape of clinical trials evolves rapidly, and your print partner should evolve alongside it, continuously enhancing their systems and capabilities to meet emerging challenges.

For over 45 years, Greens has partnered with pharmaceutical companies to deliver clinical trial print solutions that combine security, precision, and global reach. Our approach addresses the specific challenges procurement professionals face: 

• End-to-end control: In-house production provides complete traceability and consistent standards across all materials 
• Global reach: Up to 40% reduction in shipping expenses and elimination of customs delays 
• Security by design: ISO 27001 certification and purpose-built facilities 
• Technology-enabled management: Real-time visibility through our online portal 

Get in touch to discuss your specific needs.