TS CSV QA: About Us

Trev Simmons founded TS CSV QA in 2017. Trev brings nearly 25 years' experience of Pharmaceutical IT support, working for sponsors, CRO and consultancy companies, and formerly ran A1 IT Compliance from 2006 to 2014.

We have been working within the regulated pharmaceutical IT environment since 1994 in a variety of roles from IT Developer, Project / Validation Manager through to Quality Management and Quality Assurance, working across GLP, GMP, GCP and GPvP at both a local and global scale. As an IT Quality Assurance auditor, Trev has experience within the USA, Europe and Asia for Clinical suppliers such as CROs, Analytical and Clinical Laboratories, Electronic Data Capture providers (CDMS, CTMS, ePRO, IVRS and IWRS), and medical imaging (ECG, Ultrasound).

Our experience covers the full spectrum of system sizes from single user applications to global systems with tens of thousands of users across the GxPs working with full service and data management CROs, Analytical and Clinical Laboratories, Pharmacovigilance and specialist providers (EDC/ePRO, Medical Imaging, IVRS/IWRS).

Trev is an active member of the Research Quality Association who regularly presents at conferences and seminars, contributes to industry journals and participates in industry initiatives.

Trev currently acts Chair of the Digital Information Governance and Information Technology (DIGIT) Committee as well as the Cross-GxP Working Party on Data Integrity, and teaches Quality Risk Management, Computer System Validation and Data Integrity.