Study Management
- We always strive to decide based on what is in the patient’s best interest as well as in accordance with the clinical study protocol and GCP
- Knowledge of Investigator´s Brochure (IB) and adverse profile of study drug (safety aspects)
- Study issues are conducted according to our Standard Operating Procedures (SOPs)
- Study related procedures are performed only by certified and trained staff. Any activities delegated to third parties are closely monitored by the Investigators
- Source data is provided in printed records and is checked for sufficiency and consistency prior to monitoring
- Patients are thoroughly informed about benefits, safety aspects and the study´s schedule and are only considered eligible for signing the Informed Consent after a sufficient respite
- Patient and study documents are treated confidentially
- SAE reporting within 24 hours of notification by investigator