Clinical Monitor

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.

Learn more about our consulting services and the training of Clinical Monitors - Click here!

EMA Pharmacovigilance
Health care studies
Observational studies
EMA Pharmacovigilance
Medical Biometrics
Approval of Medical Devices
Clinical Investigators
Clinical Trials
GCP Legislation
GCP - Good Clinical Practice
GCP Guidelines
GCP Compliance
Clinical Research Organisation
Contract Research Organisation
Pharmacoeconomics, Health
Pharmacoeconomic studies
Patient Monitoring
Monitoring Clinical Trials
Clinical Monitor
Marketing Authorisation
Medicinal Product Approval
Drug safety
Data management plan
Clinical development
Monitoring investigators
Non-interventional studies (NIS)
Patient recruitment
Phase IV studies
Investigator audit
Investigator qualification
Investigator selection

EMA Pharmacovigilance · Health care studies · Observational studies · EMA Pharmacovigilance · Medical Biometrics · Approval of Medical Devices · Pharmacovigilance · Clinical Investigators · Clinical Trials · GCP Legislation · GCP - Good Clinical Practice · ICH GCP E6 · GCP Guidelines · GCP Compliance · BfArM GCP · Clinical Research Organisation · Contract Research Organisation · PSUR · PSURs · Pharmacoeconomics, Health · Pharmacoeconomic studies · Pharmacoeconomics · Patient Monitoring · Monitoring Clinical Trials · Clinical Monitor · Marketing Authorisation · Medicinal Product Approval · Drug safety · Data management plan · Clinical development · Monitoring investigators · Non-interventional studies (NIS) · Patient recruitment · Phase IV studies · Investigator audit · Investigator qualification · Investigator selection