Contract research organisation

A Contract Research Organisation (Clinical Research Organisation - CRO) takes over the planning and execution of clinical studies. These can be registration studies or non-interventional studies (NIS) from the field of drug studies (AMG) or medical device studies (MPG).

The Contract Research Organisation can take over all tasks of organisation and planning of the study, writing of the observation plan or study protocol, taking over the submission/notification to the authorities (BfArM , Ethics Commission and Central Association of Health Insurance Companies), database creation, randomisation, monitoring and data acquisition. In addition, the contract research organization can specify the statistical evaluations (biometrics or biostatistics) in a Statistical Analysis Plan (SAP), carry out the medical statistics after a plausibility check and summarize the study results in a final report as part of medical writing. Medical writing must be based on sound medical knowledge, so all documents and reports must be of high quality. To ensure this, all processes are described by Standard Operating Procedures (SOP `s) and regulated and standardized by quality management procedures.

As further quality measures, internal and external quality controls are carried out or planned audits are prepared and supported by the Contract Research Organisation. Here, the CRO assumes the sponsor's tasks in conducting audits in which the study centres are reviewed and evaluated.

At the end of the clinical trial, the CRO can also pay the study physicians and register the study results in databases. The CRO can also take over the entire project management and act as a link between the sponsor and the investigators or study nurses. The CRO can also select study sites or organise investigator meetings.

The Contract Research Organisation acts on behalf of the sponsor, who usually comes from the pharmaceutical industry or is a manufacturer of medical devices. The CRO takes over contractually defined tasks, whereby the main responsibility for the overall project - as well as the rights to the results/new scientific findings - remains with the sponsor.

Within the scope of its obligations, the CRO always ensures that the study plan is adhered to and that the study is conducted in accordance with the law, including GCP - Good Clinical Practice. For this purpose, monitoring is carried out by the Clinical Research Associates (CRA) in the study centres. An essential task of the CRA is a source data verification (SDV) - this is a comparison of the source data with the CRF - to ensure that the study data is correct and complete. The CRA also verifies that the investigational drugs or investigational products are stored correctly, that the patient identification lists are kept correctly and completely, that the consents are correctly signed by the investigator and patients, and that any serious adverse events (SAE) that may occur have been reported in accordance with the law. As soon as questions or discrepancies arise, the CRO sends queries to the trial sites, so that as many discrepancies as possible are resolved and data quality is improved.