Services

Quality Management

We work with our research sites to ensure that high quality standards are in place for facilities, procedures and staff and that all studies are conducted in accordance with the expectations of our customers. Our Quality Management Program has the following components.

ICH and GLP Compliance. Services are conducted in compliance with all applicable laws and regulations, including International Conference on Harmonization (ICH) and Good Laboratory Practices (GLP). Sponsors and responsible regulatory authorities have access to relevant records, programs and data as may be reasonably requested for purposes related to filing and prosecution of submissions to regulatory agencies.

Standard Operating Procedures. Sites have developed and maintain efficient and effective processes and standard operating procedures (SOPs) to be used in performance of the work that comply with ICH and GLP guidelines.

Animal Welfare. Research conducted on vertebrate animals under one of our service agreements is compliant with the Animal Welfare Act [7 U.S.C. 2131 et seq.] and associated regulations from the Department of Agriculture [9 CFR, 1.1-4.11] pertaining to the humane care, handling and treatment of vertebrate animals held or used for research, teaching, or other activities.

Maintenance of Records for Regulatory Purposes. Sites maintain all applicable records and data relating to the services during and after the term of the Agreement and in compliance with all applicable legal and regulatory requirements, including requirements of the U.S. Food and Drug Administration, the European Medicinal Evaluation Agency, and other regulatory agencies in Europe or other jurisdictions identified by customer.