Clinical Monitoring/Remote Monitoring/Central Monitoring

files/template/images/Clinical_Monitoring.JPG

GCP-Service offers high quality Clinical Monitoring for phase I to IV drug trials and pre- and post-market medical device studies according to your or our SOPs, ICH/GCP, ISO 14155 and the national laws all over the world.

We have very good expertise in studies with drugs and medical devices. Correct procedures are followed and the scientific as well as the ethical conduct of the study is uncompromised. All types of Monitoring Visits are performed by GCP-Service:

  • Site Qualification Visits
  • Site Initiation Visits
  • On-Site Monitoring
  • Site Closure Visits
  • Remote Monitoring

Depending on study purpose and study design clinical monitoring can be replaced by remote monitoring activities which saves time and costs (travel time and costs) on one hand but does not need to influence patient safety, patient rights, data quality and data integrity in many studies on the other hand. We support sponsors to find the right balance of clinical onsite monitoring and remote monitoring activities to make sure that the best study quality can reached according to the purpose of the study.  

For centralized monitoring statistical information e.g. SDs, trends, outliers are monitored by our statistical department. This process supports the clinical operation team to react on conspicuous effectively.

GCP-Service has a large study site and investigator data base including private-practices as well as clinics. Close contact to good study sites is the basis of high quality data and fast study conduct. The excellent presentation and training skills of GCP-Service help to avoid protocol deviations at the early stages of a clinical trial.

The CRA team of GCP-Service has experience in the following medical indications:

  • Aesthetic Medicine
  • Allergy
  • Burn Wounds
  • Cardiovascular Diseases
  • Dermatology
  • Gastro-Intestinal Diseases
  • Gynaecology
  • Infectious Diseases
  • Metabolism
  • Nephrology
  • Neurology
  • Neurosurgery
  • Obesity
  • Ophthalmology
  • Oncology
  • Orthopaedics
  • Paediatrics
  • Respiratory Diseases
  • Surgery
  • Urology
  • Vaccination