Case Study: Safety/Pharmacovigilance #1
The objectives of the program are to: maintain a prospective representative database of the treated population during normal clinical practice, aimed to provide data on clinical safety, and closely monitor the usage of the product in the EEA countries, and monitor the use of the product in clinical practice.
Ongoing monitoring of events of special interest, SmPC compliance, benefit risk analysis of 8316 patients enrolled in 990 sites in Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Luxembourg, NL, Norway, Portugal addressing protocol and CRF design, regulatory support, Pre-selection, Study site initiation (Post & telephone), SRP management, EDC/Paper CRF design and production, site visits (ad hoc), data collection and entry, All AE/SAE handling and databasing, PSUR, descriptive statistical analyses.
A key driving factor for the client was the need to collect CRF data using a hybrid system in all countries as required. Additionally this was not mandatory program in all countries, so the methodology had to be user friendly in order for unpaid physicians to be motivated to complete CRFs.
Design: ability to collect data from CRF via hybrid solution and local office/language capability
EDC/Paper CRF hybrid:
• Gave inexperienced treating physicians a choice of reporting thus increasing enrollment
• Central AE monitoring with specialist medical support as AE data was the key data
• Central website with stratified access by client
• Local PAREXEL offices provided enquiry hotlines and local language follow up of CRF and AE queries
• High level technical support and accountability at PD level (as requested by client)
Delivered client and multi-lingual program needs within a flexible start up and program close schedule for each county. Study closed, safety objectives met allowing client to make strategic decision on product life cycle.