At SEMELO Health Care Company, we provide comprehensive support throughout the entire lifecycle of your clinical trial, ensuring your data management processes are compliant, accurate, and efficient. Our team of seasoned experts is proficient in regulatory guidelines from FDA, EMA, 21 CFR Part 11, and ICH-GCP, offering you peace of mind that your clinical trial data meets the highest industry standards.

Key Services and Expertise

1. Regulatory Compliance and Expertise:

• Regulatory Adherence: Our data managers ensure your clinical trial data management adheres to guidelines from FDA, EMA, 21 CFR Part 11, and ICH-GCP.
• Industry Standards: We align with current data standards such as SDTM, CDASH, and other CDISC standards.

2. Comprehensive Data Management:

• (e)CRF Design and Preparation: Custom electronic and paper case report forms (CRFs), including annotated CRF preparation.
• Database Design: Tailored database solutions to fit your clinical trial needs.
• Clinical Data Entry and Validation: Accurate and timely data entry and validation processes to ensure data integrity.
• Laboratory Data Handling: Efficient management and integration of laboratory data.
• Medical/Dictionary Coding: Standardized coding practices to maintain consistency and accuracy.
• Query Management: Proactive query management to resolve data discrepancies promptly.

3. Quality Control and Database Lock:

• Blinded Data Reviews: Objective review processes to ensure data integrity.
• SAE Reconciliations: Systematic reconciliation of serious adverse events.
• Status Reports and Statistics: Regular reporting to keep you informed of your trial’s progress.
• Statistical and Integrated Reports: Comprehensive reports that provide actionable insights.

4. Third-Party Vendor Management:

• Seamless Coordination: Effective management and coordination of third-party vendors to ensure smooth data management operations.

Our Commitment to Excellence

• Accuracy and Integrity: We prioritize the precision and reliability of your clinical trial data.
• Timely Delivery: We meet critical deadlines, providing high-quality results within stipulated timelines.
• Agile Reporting: Fast, reproducible reporting tailored to your specific needs.
• Source-Verified Data: Rigorous verification processes to ensure data authenticity.
• Cost-Efficient Solutions: High-quality data management solutions designed to be cost-effective.

Partner with SEMELO Health Care Company for top-tier clinical data management services. Let us navigate the complexities of data management, providing you with expert guidance and a steadfast commitment to accuracy and efficiency.