Pharmacovigilance and drug safety software play a crucial role in monitoring the safety of pharmaceuticals throughout their lifecycle. Here are some key aspects and features of such software:
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Key Functions
- Adverse Event Reporting: Allows healthcare professionals and patients to report adverse drug reactions (ADRs) easily.
- Data Management: Centralizes data from various sources, ensuring that all reports are stored securely and can be accessed easily.
- Signal Detection: Analyzes data to identify potential safety signals and trends related to drug use.
- Risk Management: Helps in developing risk management plans (RMPs) to mitigate identified risks associated with a drug.
- Regulatory Compliance: Ensures adherence to regulations from authorities like the FDA, EMA, and others by generating necessary reports and documentation.
- Case Processing: Facilitates the evaluation, processing, and follow-up of individual safety cases.
- Integration with EHR/EMR: Allows for seamless integration with electronic health records (EHR) and electronic medical records (EMR) systems for real-time data access.
- Reporting Tools: Provides customizable reporting tools for various stakeholders, including regulatory bodies, healthcare professionals, and internal teams.
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