The head of our Quality Assurance group has worked for more than 10
years in the field of clinical trials, primarily in the areas of oncology,
rheumatology and diabetes.
She is an ACRP-certified clinical research associate and holds an MSc in pharmaceutical medicine.
She has extensive experience in the following activities:
- Site monitoring
- Study coordination and management
- Study evaluation and reporting
- Training
- Preparation and maintenance of standard operating procedures
- Auditing
- Implementation of standard operating procedures
- Training
- Internal audits:
- Safety handling audits (e.g. safety database)
- Critical document audits
- Clinical data management audits
- Clinical/statistical report audits, including audits of database, statistical tables and report structure, SAE narratives and in-text tables
- External audits:
- Investigator site audits
- Case report forms (source data verification)
- Drug accountability
- Contract laboratory audits (e.g. GLP audits)
- Pre-qualification audits
The Accovion independent Quality Assurance group will ensure that:
- Your projects are conducted efficiently and in accordance with highest quality standards
- Regulatory authorities and the health care community are provided with high-quality submissions and products
Accovion employees will perform all clinical investigations and projects
in compliance with:
- Accovion or client's policies and SOPs
- International standards and regulatory requirements
Worldwide regulations require the development and maintenance of a quality
system. You can rely on Accovion for quality every step of the way:
- We make sure that the study data is transferred accurately at every point from the source documentation all the way to the submission
- Through audits and in collaboration with you, our regulatory team will ensure that your product meets the standards expected by global regulatory bodies
Our procedures and processes are continuously reviewed in the light of changing regulations and improved to ensure highest standards of technologies.
All Accovion activities are controlled by a comprehensive library of written
SOPs, which are available for inspection by our clients on request.
These SOPs cover all aspects of our operations.
