Clinical monitoring supervises the continuous progress of a clinical study and ensures that it is conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements. This is also important for studies in the food area.
Clinical monitoring is crucial for human subject protection and integrity of data. It is an important aspect to ensure your success. To ensure the conduct of high-quality studies the Clinical Research Associate (CRA) supports study sites and supervises recruitment and study progress. Thus, the CRA represents an essential link between the sponsor and the study site or the investigators.
Our Clinical Research Associates (CRAs) have years of experience in project management and conduction of clinical studies in the food area and are familiar with the upcoming challenges and conditions of these studies. Our know-how ensures solution-focused monitoring of your clinical study with effective query management and a close collaboration between all members of the clinical study to guarantee an optimal study performance.
Clinical monitoring contains:
Preparation of monitoring plan
Site initiation visit, interim and close-out visit
Source Data VerificationTraining of study site members