Quality Assurance

Many of the quality control measures of the lab are described in the specified sections such as training, equipment and data management. The Core Lab has a 100% quality control process. All studies are initially analyzed by a trained technician / sonographer and are then reviewed by a board certified Cardiologist to ensure accuracy.

Once studies are entered into the electronic case report form, they are uploaded into an Access database. The data is then queried for pre-specified data checks

(which are study specific depending on the parameters being analyzed) before data is locked and sent to the sponsor or CRO. The Core Lab will work with sponsors to identify the elements that should be checked during the QA process and will develop and document a process to meet these quality control measures.