GCP – Focus On Clinical Studies & Patient Safety

Pharmacogenomic services for clinical studies.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. They involve the participation of human subjects. When generating clinical trail data that is intended to be submitted to regulatory (which is part of a drug registration or licensing), GCP guidelines must be adhered to.

GCP for strict guidelines on ethical aspects of clinical studies

The main focus of GCP is to ensure that the rights, safety and well-being of the trial subjects (humans) are protected according to the Declaration of Helsinki and all clinical trial data are mutually accepted by regulatory authorities.

Key requirements of GCP accreditation

Overall requirements are similar to GLP. Any additional requirements are as follows:

• GCP specific trial conduct
• Patient safety
• Informed consent
• Blinding and unblinding, preparation and distribution of clinical kits
• Approval of all GCP studies by independent ethics commission

Compliance with GCP is ensured through customer audits and independent internal inspections (QA program). Certification of individual studies by national GCP authorities is possible, but not mandatory.

Eurofins Genomics is committed to delivering products, services and applications that are at the highest quality.

GCP (Good Clinical Practice) is the basic QA standard Eurofins Genomics offers for the conduct of clinical trials.The following applications can be offered if submission or registration to national authorities is necessary:

The GCP standard is applied to the following Eurofins Genomics products and services offering:

• Genotyping & Gene Expression
• Custom DNA Sequencing