Precision data collection starts with smart CRF design

At Amarex Clinical Research, an NSF company, we understand that accurate data collection is the foundation of every successful clinical trial. That’s why we specialize in designing Case Report Forms (CRFs)—both paper and electronic (eCRFs)—that are aligned with study protocols, regulatory requirements, and real-world clinical workflows.

Our CRF design process ensures that every data point collected is purposeful, validated, and ready for analysis—minimizing errors, accelerating timelines, and supporting regulatory success.

Why CRF Design Matters

A well-designed CRF does more than collect data—it ensures:

• Protocol alignment for accurate endpoint tracking.
• Minimized data entry errors through intuitive design.
• Logical flow that mirrors the patient journey.
• Regulatory compliance with CDASH, FDA, EMA, and ICH-GCP standards.
• Faster database lock and cleaner datasets.

Our CRF Design Best Practices

1. Protocol-Driven Design: We ensure every CRF is built around your study’s objectives, endpoints, and safety assessments. Our cross-functional team—including clinical, regulatory, safety, and statistical experts—collaborates to ensure alignment from the start.
2. Error-Resistant Layouts: We use clear, concise language and structured fields (e.g., dropdowns, checkboxes) to reduce ambiguity and prevent inconsistent data entry.
3. Logical Organization: CRFs are structured by visit and clinical assessment, following CDASH standards and reflecting the natural flow of patient care.
4. Rigorous Testing & Validation: Before deployment, all CRFs undergo extensive testing with sponsors and internal teams to ensure usability, accuracy, and compatibility with data systems.

Amarex WebView EDC: Real-Time, Reliable, and Ready

Our proprietary WebView EDC platform supports:

• Real-time data entry and monitoring.
• Built-in validation checks for immediate error detection.
• Instant access to data metrics and dashboards.
• Remote monitoring and mid-study updates.
• Seamless integration with safety and statistical workflows.

Avoid the Pitfalls of Poor CRF Design

Poorly designed CRFs can lead to:

• Incomplete or inconsistent data.
• Regulatory delays or rejections.
• Increased site burden and query volume.
• Compromised study integrity.

At Amarex, we mitigate these risks through a standardized eCRF library built on years of experience, CDASH compliance, and therapeutic area expertise. This allows us to deliver high-quality, study-specific CRFs—faster.

Therapeutic Expertise

We’ve successfully designed CRFs for studies in:

• Oncology.
• CNS Disorders.
• Infectious Diseases.
• Rare and Orphan Conditions.

Let’s Build Better CRFs Together

Whether you’re launching a first-in-human study or preparing for regulatory submission, Amarex ensures your CRFs are accurate, compliant, and built for success.

Contact us today to learn how our CRF design services can elevate your clinical trial.