Preclinical/Phase I
ICON Development Solutions provides strategy and management in support of non-clinical drug development for all Phases.
Quality Control/Assurance
In addition to providing in-house Quality Assurance auditing for all clinical trials, the Quality Assurance department provides stand alone services to support companies to develop, implement and maintain quality management systems to assure the highest standard of conformance to GCP, GMP and GLP regulations and to ISO 9000 quality standards.
- Auditing
- Phase I facilities
- Phase I - IV GCP audits
- Clinical laboratories (GCP, GLP)
- Database and Statistical tables
- Computer validation
- Clinical trial reports
- Pre-FDA/regulatory inspections
- Quality Systems Development (GCP, GLP, ISO 9000 Quality Standard)
ICON has the resources to meet all your auditing requirements of Phase I - IV clinical trials. With QA personnel located across Europe and the US, Asia-Pacific, Latin America and Japan the ICON QA team is flexible enough to provide an individual and personalised service for locally managed projects.
