Targeted Source Data Verification

Ergomed’s Risk-Based Clinical Monitoring and Source Data Verification Approach for Data Integrity

Ergomed ensures the highest data integrity and patient safety standards through our risk-based clinical monitoring and Source Data Verification (SDV) practices. SDV is a critical process in clinical trials that ensures the data collected are accurate, complete, and verifiable against the source documents. We compare data entered into case report forms or electronic data capture systems with the source data to confirm their accuracy and reliability.

Why is SDV Important?

Patient Safety

SDV helps ensure patient data are accurate, which is crucial for making informed decisions about patient safety.

Data Reliability

Verifying data against source documents ensures that the data used for analysis are reliable and can withstand regulatory scrutiny.

Regulatory Compliance

SDV is a regulatory requirement mandated by agencies like the FDA, EMA, and ICH to ensure the integrity of clinical trial data.

Ergomed’s Risk-Based Clinical Monitoring Approach

To ensure your data’s accuracy and integrity, Ergomed employs a risk-based clinical monitoring approach. The FDA, EMA, ICH, and other regulators increasingly prefer and recommend risk-based monitoring in clinical trials. It ensures the optimization of monitoring efforts, complete oversight, and early identification of risks to patient safety or data reliability.

Our Risk-Based Monitoring Strategies Can Include the Following:

  • We utilize advanced statistical methods to identify data trends and outliers. This helps us pinpoint potential issues early, allowing for timely interventions and ensuring that your trial data remain accurate and reliable.

Ergomed’s Comprehensive Oversight and Early Risk Identification

Ergomed’s risk-based monitoring approach ensures that your clinical trials maintain the highest data integrity and patient safety standards. Our SDV practices and innovative monitoring strategies ensure that your trial data are accurate, reliable, and compliant with regulatory requirements.

Contact us today to learn how Ergomed’s risk-based monitoring services can support your clinical research needs and help you achieve your clinical trial goals.

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