Compliance

PRODUCTS

  • 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.

  • Engineered from the ground up following the latest Annex 1 revision. With 100% level of quality inspection and advanced reject management, roboFIL™ enhances quality assurance, supporting a robust Contamination Control Strategy (CSS).

  • The CliniMACS Prodigy® represents the next generation in automated cell processing. This device offers advanced integrated solutions to streamline cell processing workflows – from cell separation through cell culture to formulation of the final product.

  • Industry leading pharmacovigilance solutions from clinical development through post-approval.

  • AES Box™ is a modular architectural system that delivers our best-in-class modular cleanroom design and integrates seamlessly with your current project infrastructure while providing the compliance and quality you need.

WHITE PAPERS AND CASE STUDIES

NEWS