Compliance

PRODUCTS

  • Meet FDA guidelines for GMP in tablet and capsule production with a secure, failsafe system. Qualification reports are available.

  • Electronic informed consent for patient-centric decentralized clinical trials.

  • 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.

  • The most widely trusted solution for clinical trial disclosure management

    Managing clinical trial disclosures can be tedious and error-prone, opening the door to noncompliance. TrialScope Disclose provides a better way.

    Our centralized platform automates data entry and reporting for Clinicaltrials.gov, CTIS, and more. This reduces manual effort so you can focus on bringing new treatments to patients, not paperwork.

  • The SamuxMP Auto is the automated mass photometer for AAV characterization, autonomously measuring up to 24 samples in approximately 90 minutes. The instrument rapidly measures AAV empty/full ratios, sample purity and particle aggregation for any AAV serotype – with high precision and reproducibility.

WHITE PAPERS AND CASE STUDIES

NEWS