Ready for Inspection and Oversight Activities
Ana Luísa, Head of Quality Assurance and Francisca Lemos, Quality Assurance Associate
The vast experience of our group of auditors, our knowledge in ICH-GCP, local legislations, as well as our connections with Quality Associations – members of Research Quality Association (RQA) – enables us to follow the newest trends of this area and continuously improve our services.
Are you prepared?
Aware of the stressful demands with national and international regulations to all the entities involved in clinical research activities, along with the new tendencies related with the implementation of risk-based monitoring, the role of outsourced Quality Services has increased, namely in the development of strategies to guarantee projects implementations aligned with the highest quality standards (Good Clinical Practices – GCP) with the minimization of the regulatory risks.
Eurotrials can assist its clients in an efﬁcient manner so that their research projects are always READY FOR INSPECTION!
Several Quality Services can be provided in all Eurotrials geographies to complement the typical clinical trial audit.
Cover all the details
We can create a quality framework for study operational excellence by delivering oversight activities services at site level. The focus of these activities are targeted quality control visits, that enable an effective site management by proactively identifying and mitigating risks. These services also encompass the assessment of any external third parties providers involved in the conduction of the studies.
Eurotrials’ Quality Assurance personnel as well as Quality Control Staff within operational Units have a large experience in oversight activities, being able to support Sponsors in Europe and Latin America.
General Quality Consultancy
- General Consultancy
- Gap Analysis and Risk Assessment
- Elaboration and revision of SOPs
- Planning, organization and training in new SOPs
- Building Capabilities for clinical trials conduct in of research sites
Regulatory Inspection Support
- “Mock” Preparatory audits at research sites
- Site Staff Training and Preparedness
- Sponsor/CRO Training and Preparedness Preparation of the responses to inspection report
- Post-inspection follow-up
- Quality Control Visits – Targeted to assess CRA performance
- Oversight of Site activities
- Qualiﬁcation of investigators
- Revision of TMF