Pharma companies are required to download E2B R3 files from the EV Web portal based on active substances (not based on the company’s products). Due to this regulatory change, Pharmacovigilance operations at small to mid-size companies are challenged with timely completion of review and submission of huge volumes of ICSRs. It is must for companies to include these ICSRs in the company’s centralized safety database to comply with other regulatory agencies for expedited reporting.
Key Product Features
L2A Case Filter provides various, ready to use dashboards and reports to manage the process efficiently.
- Dashboard for total cases processed in a specific time interval with details of success and non-success numbers
- Total number of cases received for a country and processed based on report type
- Multiple trend reports indicating total number of cases reported by time interval, source, product etc
Compier L2A Case Filter directly reduces manual effort and address the regulatory compliance needs of the pharmacovigilance department.
How Do we Deliver
Compier L2A Case Management is a component of our Compier platform. It can be deployed on its own or in combination with other modules of the platform.
New Insights
Food & Nutraceuticals: How Companies can Prove Health Value with Clinical Trials
What are Food and Nutraceuticals? ‘Nutraceuticals’ is a composite term of ‘nutrition’ and ‘pharmaceutical’. They are a blend of products that possess both nutritional as well as medicinal value. They are designed to improve physical health, boost immunity, and deal with stress and increase longevity. Nutraceutical products play a significant role in maintaining normal physiological [...]
Best Practices for Signal Management in Pharmacovigilance
Pharmacovigilance involves the collection, detection, assessment, and monitoring of data on Adverse Drug Reactions (ADRs) which must be evaluated to derive vital safety information. Signal detection involves monitoring the adverse reaction data for patterns that suggest new safety information. Safety signals can be detected from an extensive range of sources, such as spontaneous reports, clinical [...]
Enabling eSource in Clinical Studies to Optimize Trial Quality
Source data is all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. The electronic data source or eSource is the data that is initially recorded in electronic format in this process. Biopharma and [...]