Q: What is a Clinical Label?
A: Clinical labels are used to identify and control investigational study materials from packaging through final use by a patient during a clinical trial. Clinical Systems, Inc. provides the highest quality, state-of-the-art clinical labels in any configuration you may require.
Q: Why Are Clinical Labels Needed?
A: Clinical labels are needed for packaging and distribution of clinical trial materials. Effective label design can augment the productivity and efficiency of the clinical packaging and distribution process. Effective labels also communicate key information to assist the study investigator and the site nurse in dispensing the correct medication in the correct sequence to the correct patient. Patient compliance can be improved with explicit label directions. Good label design can also assist in emergencies making essential information readily available.
Q: Are there Regulatory Requirements for Clinical Labels?
A: Yes. The United States Food and Drug Administration (FD) dictate U.S. Requirements. In Europe, requirements are decided by the European Medicines Agency (EMEA) and National Health Authorities dictate local country requirements.
Q: From Where Do I Request Clinical Labels?
A: If you don’t have an in-house clinical label group, you’ll want to contact Clinical Systems, Inc., to obtain a quote for your specific needs.