Sector
Clinical Trials
Validation of EDC, eTMF, CTMS systems and clinical data management compliant with 21 CFR Part 11, GDPR, and GCP/ICH E6(R2). We support CROs, sponsors and investigators in managing the lifecycle of clinical trial data.
Applicable regulations
Do you work in this sector?
We have experts specialised in the regulations applicable to your industry. Tell us about your case.
Request informationServices for this sector
System Validation
Complete validation of computerized systems: ERP, LIMS, MES, mobile applications, medical devices and AI systems under GxP regulations and 21 CFR Part 11.
Data Integrity
Assessment and improvement of data integrity controls in accordance with ALCOA+, with remediation plans and training to ensure reliable and auditable data.
Auditing
Internal audits, technology vendor and third-party audits to identify compliance gaps and prepare your organization for regulatory inspections.
Training & Qualification
Specialized training programs in GxP, CSV, data integrity and regulatory requirements for quality, IT and operations teams.