During the clinical trial process, pharmacovigilance is a key link to ensure the safety of subjects, maintain public health, and promote the smooth progress of drug research and development. It aims to ensure the safety and effectiveness of drugs during the clinical research and development process, and to protect subjects and drug use. the health rights of the population. Our pharmacovigilance supporting services are dedicated to providing customers with comprehensive and professional drug safety monitoring and risk management support. The following is a detailed introduction to pharmacovigilance supporting services:
**1. Service Overview**
Pharmacovigilance supporting services cover the safety monitoring and risk management of drugs from R&D to marketing, including drug safety monitoring during clinical trials, collection/assessment/reporting of adverse events (AEs) and serious adverse events (SAEs) and tracking, as well as post-marketing safety monitoring and risk assessment of drugs.
**2. Service content**
1. **Pharmacovigilance during clinical trials**:
- Establish a dedicated pharmacovigilance team to be responsible for drug safety monitoring during clinical trials.
- Develop and implement pharmacovigilance plans to ensure safety and compliance of clinical trials.
- Collect, evaluate, report and track AE/SAE in a timely manner to ensure the safety of subjects.
- Provide drug safety data analysis and risk assessment reports to support clinical decision-making.
2. **Post-marketing Pharmacovigilance**:
- Monitor the safety of post-marketing drugs and collect and analyze drug safety information from the market, patients and physicians.
- Evaluate and report drug safety incidents and take necessary risk management measures in a timely manner.
- Provide post-marketing drug safety monitoring reports and risk assessment reports to support the marketing and re-evaluation of drugs.
3. **Regulatory Compliance and Compliance**:
- Strictly abide by domestic and foreign pharmacovigilance-related regulations and guidelines to ensure compliance of services.
- Regularly update regulatory knowledge to ensure that service content keeps pace with the times.
4. **Technical Support and Training**:
- Provide technical support and consulting services related to pharmacovigilance to help customers solve drug safety issues.
- Carry out regular pharmacovigilance training to improve customers' awareness and emphasis on drug safety.
**3. Service advantages**
1. **Professional Team**: We have an experienced pharmacovigilance team with profound pharmacovigilance knowledge and rich practical experience.
2. **Efficient System**: Use advanced pharmacovigilance systems and technical means to ensure the timely collection, assessment, reporting and tracking of AE/SAE.
3. **Comprehensive Service**: Provide pharmacovigilance services throughout the entire process from clinical trials to post-marketing, ensuring safety monitoring throughout the entire drug development cycle.
4. **Compliance Guarantee**: Strictly comply with domestic and foreign pharmacovigilance-related regulations and guidelines to ensure the compliance and reliability of services.