The Clinical Research Bureau of VU Medical Center and the Amsterdam Medical Center offers an embedded infrastructure by providing guidance and advice to secure quality compliance.
- guidance in getting approval from the Medical Ethical Committee (MeTC) or Institutional Review Board equivalent
- auditing and monitoring of clinical research
- a Data Safety Monitoring Board (DSMB)
- advice and guidance regarding legal aspects, data analysis and data management
- advice on protocols and conduction of clinical studies according to Good Clinical Practise (GCP) and using EPIC-based electronic health records
- advice and guidance on the initiation and setup of new clinical studies.
Collaboration VUmc-CHDR (Phase I studies)
- Unique collaboration of CRO (CHDR) with independent in-house capacity (30-60 beds) and VUmc with specialized CT unit (2 beds) linked to the PET facility
Collaboration VUmc Alzheimer Center and Alzheimer Research Center BV (CRO) – Phase I and II studies
- Clinical Trials in AD are executed in collaboration between VUmc and the Alzheimer Research Center BV, a CRO affiliated to Vumc. Moreover Amsterdam Neuroscience is setting up a national Healthy Brain Registry to identify more trial ready healthy controls subjects interested in participating in clinical trials.
Collaboration VUmc Multiple Sclerosis center – Phase III and IV studies
- Clinical Trials in MS are executed in collaboration between VUmc and international consortia (sponsored by industry). Moreover the MS center of Amsterdam Neuroscience is setting a national registry for MS patients
Collaboration AMC Investigator Initiated Clinical Trial consortia for Parkinson’s Disease – IIT studies
- Clinical Trials in PD (including comparison of pharmacologica intervention versus deep brain stimulation) are executed in Amsterdam in collaboration with several national consortia
Collaboration AMC Investigator Initiated Clinical Trial consortia for Meningitis and CIPD (Chronic Inflammatory Demyelinating Polyneuropathy) – IIT and phase III studies
- Clinical Trials in Meningitis and CIDP are executed in Amsterdam in collaboration with several (inter-)national consortia
Collaboration AMC Investigator Initiated Clinical Trial consortia for Neurovascular Disorders (CVA) – Phase II and IIT studies
- Clinical Trials in CVA (Neurosurgeory vs cardiovascular treatment) are executed in Amsterdam in collaboration with several national consortia, and sponsored by CVON