Literature screening
The requirement to proactively screen the published medical and scientific literature as part of a pharmacovigilance system can lead to difficulties: the screening can be time-consuming and resource intensive; inadequate searches are a common finding during regulatory authority inspections; and the identified cases can be complex and difficult to evaluate and to enter onto the safety database.
PrimeVigilance staff are experienced in carrying out this activity and can comprehensively manage your literature screening requirements in a cost-effective manner. Involving medical review of cases rather than adopting a mechanistic approach can also help to identify important signals in the literature.
We can also carry out literature searches for purposes of signal evaluation or for identifying safety concerns for inclusion in PSURs.
Literature Screening: Compliant and Aware
- just one of the pharmacovigilance services from PrimeVigilance
For more information contact PrimeVigilance today