Quality Management System /

Monitor procedures

  • Quality Improvement project in various Dutch hospitals, to improve and implement an adequate Quality Management System for conducting clinical trials and Investigator Initiated Trials.
  • QA Manager at Biotech companies, Data Management/Pharmacovigilance CRO, Phase I CRO, interim QA Manager at a top-10 Pharmaceutical company.
  • SOP revisions for Medical Device companies.

CRO / Vendor Audits

  • Full service CRO qualification audits and compliance audits.
  • Vendor audits ((e.g. Pharmacovigilance, Data Management, Laboratory, computerized system audits).

Internal Audits

  • Performing internal audits on study processes and assessing the completeness of the related study files for a Top-10 pharmaceutical company.
  • Internal auditor of company processes at a phase I CRO.

Training GCP / SOP

  • Customized GCP training for medical writers and data managers.
  • GCP training for a CRO.
  • In-company SOP training.

Curriculum Vitae

Inge van Gasteren has been involved in various positions in the clinical research industry during the last 30 years.

In Summary:

  • 2011 - Managing Director IGQC B.V.
  • 2007 - Associate Director Clinical Development at an int. pharmaceutical company
  • 2005 - Clinical Research Manager at an international pharmaceutical company
  • 2004 - Project Manager Clinical Operations at a medical device CRO
  • 2003 - International Clinical Research Associate
  • 1992 - Clinical Research Associate for several CROs and pharmaceutical companies

For more detailed information, please download my CV.