Wise Pharmacovigilance & Risk Management
Wise Pharmacovigilance and Risk Management Ltd is dedicated to providing expert services in pharmacovigilance and risk management to help clients meet patient safety and regulatory requirements. Led by experienced professionals, the company offers services including signal management, benefit-risk management, risk management planning, and pharmacoepidemiology, with a focus on compliance, safety, and effective risk assessment.
Industries
Nr. of Employees
small (1-50)
Wise Pharmacovigilance & Risk Management
Services
Consultancy to ensure signal detection and management processes meet global requirements, incorporate data-mining and company data review, and maintain audit trails for inspection readiness.
Advisory and authorship support for benefit–risk documentation and analysis, including implementation of ICH M4E(R2) and preparation of aggregate safety reports.
Design and implementation advice for risk management activities, creation of Risk Management Plans, and development of risk minimisation measures and evaluation studies for global deployment.
Study design advice and protocol creation for post-approval safety studies using EHRs or primary data; full study execution services including database study design, execution, and report writing in alignment with GVP VIII, ENCePP, and GPP.
Consultancy to ensure signal detection and management processes meet global requirements, incorporate data-mining and company data review, and maintain audit trails for inspection readiness.
Advisory and authorship support for benefit–risk documentation and analysis, including implementation of ICH M4E(R2) and preparation of aggregate safety reports.
Design and implementation advice for risk management activities, creation of Risk Management Plans, and development of risk minimisation measures and evaluation studies for global deployment.
Study design advice and protocol creation for post-approval safety studies using EHRs or primary data; full study execution services including database study design, execution, and report writing in alignment with GVP VIII, ENCePP, and GPP.
Expertise Areas
- Pharmacovigilance and signal management
- Benefit–risk management and assessment
- Risk management planning (RMP/REMS)
- Pharmacoepidemiology and post-authorisation safety studies
Key Technologies
- Pharmacoepidemiologic study methods
- Electronic health record-based study design
- Database study design and execution
- Signal detection and data mining