Clinical Monitor - Training
A clinical monitor, also referred to as CRA (Clinical Research Associate) or site manager, is responsible for the monitoring of clinical trials at the investigational sites according to national drug law. We put together standard or individual training courses and training workshops for the further education of clinical monitors. The training is carried out by competent professionals in our seminar rooms in Cologne. This offer is of particular interest for all personnel in the area of clinical research who wish to enhance their monitoring skills. The range of topics addressed includes scientific and medical aspects.
Clinical Research - The Tasks
It is important for a clinical monitor to be thoroughly conversant with the GCP (Good Clinical Practice) guidelines for clinical studies. The clinical monitor performs the monitoring of clinical studies (clinical trials) in accordance with the requirements of the protocol. The study plan is described in the GCP guidelines as an essential study document on the basis of which the study conduct is supervised by the ethics committee and the competent authorities. Another important component of GCP is quality management, the tools of which are used by the monitors to carry out quality management.
In addition to the training of clinical monitors, Dr. Oestreich + Partner GmbH also provides skills enhancement training for project managers, auditors, managers responsible for “Standard Operating Procedures (SOPs)”, managers of “Electronic Data Capture Systems (EDC)”, data managers, physicians as investigators in clinical trials (sites), pharmacists, in addition to patients, employees in marketing and sales, and advertising agencies.
Nowadays, knowledge management in the area of health care is absolutely crucial to decision making. Frequent changes in the health care sector mean that a high level of efficiency is required in the implementation of such decisions. Dr. Oestreich + Partner GmbH supports the staff and third party contract partners of sponsor companies through quick and efficient resolution of the associated tasks and, in so doing, provides for sustained competitiveness on a broad level.