Case workflow management is very critical task in the meeting the global regulatory compliance in pharmacovigilance activities, which involves accurate case prioritization and its timely submission within stipulated regulatory timelines.
Case routing is the mechanism to manage accurate movement of the case through the different workflows in the database which is also responsible for assigning the cases in PvEdge amongst users working as case processors/QC user/Medic user (MRs). It is a key enhancement that allows case processors to manage their volume of cases.
Why PvEdge?
In PvEdge, case can be simply assigned to respective user in the dynamic workflow of pharmacovigilance case processing.
PvEdge follows standard workflow for case routing from Advance user to Medical user to QC user to Submission user. Better workload delegation between current users can be ensured if the PV manager knows how much cases are available between and within workflows.
Whenever a case/ICSR is transferred from one to another workflow back and forth. It holds many essential benefits as described below:
- Correcting internal DCRs (data correction requests-minor or major) from quality reviewer or Medics to the data entry personnel
- Efficient handling of live follow ups i.e. two/three adverse event reports received on the same day for the same patient to be processed together when the case is not submitted or locked which is helpful in collective reporting of whole safety information to concerned regulatory authority with meeting regulatory timelines
- Re-scheduling the regulatory reports as per the changes suggested in event assessments from the Medics in order to meet accuracy in regulatory compliance before the submissions
Functional efficiency
- Provides a customized workflow and routing pattern as per client’s practice (Client specific conventions)
- An accurate workflow status of a particular case as per as any case prioritization is concerned as per seriousness and reportability
- Assessment of the productivity of each user
- Ensuring accountability for case transfer
- Tracking of which user working on which case as and when required
- Case routed back in previous workflows is also routed for one case-one user approach (i.e. another user will not be able to edit the case if the case is open with a user or case owner)
- Tracking of the reasons for case transfer as a part of case life cycle
- Helps in client/internal audits which may require to confirm workflow processes and user review carried out
- Re-allocate cases/ICSR(s) in absence of a user
- User case assignment matrix provides unique option to route case to specific users in channel