A COMPLIANT PROCESS FOR LITERATURE MONITORING WHILE DOCUMENTING PROCESSING HISTORY?
HALOPV LITTERATURE MONITORING
Capture global literature monitoring activities in an easy and structured way through a web browser
Setup periodic tasks for stakeholders against general coverage or specific publications, e.g. bi-weekly with and monitor progress according to timelines
Facilitates that the process occurs smoothly and without duplication of effort. A workflow ensures that each party will review and input changes. HALO PV actions allow for opening relevant literature tools or databases
Tracks compliance to the process
Be inspection-ready with reports that demonstrate that the literature monitoring process is managed and maintained across the organization
Is GxP validated* and ready to use in the cloud
*Validation package provided with documented proof of execution of test cases according to Insife’s standard process configuration. Additional validation activities may be needed to satisfy needs for your organization.
IMPROVING THE OVERVIEW AND MANAGEMENT OF LITTERATURE MONITORING
It is a requirement to proactively screen the published medical and scientific litterature as part of a pharmacovigilance system. This can sometimes lead to difficulties: the screening can be time-consuming and resource intensive. The identified cases can be complex and difficult to evaluate and to forward into the safety database. Perhaps most importantly, maintaining an inspection-ready log of what was actually reviewed, and outputs thereof can prove difficult to manage.
Looking at the literature monitoring process from a global viewpoint, some searches are done in local and non-English publications, which may lead to having a dispersed literature monitoring process – or extensive need of translation services. In typical bi-weekly periodicities, these translations may even spill over into the next period, generating complexities for the operational overview.
Reviewing the literature itself, there are multiple options for outsourcing services or databases that can make life a little simpler. To the most essential level, it will always be a need to track and manage that activities are done according to established procedures and that there is documentation for this. Establishing direct links between the scanned literature, the assessments done and the actual ICSRs that are generated is a recommended practice, in order to be able to demonstrate the complete literature process chain.
Knowing the importance of being able to ensure timely literature monitoring with documented outputs, we have invested in making a PV tool that improves the overview and management of Literature monitoring activities. It is called HALO PV