We work with safety and pharmacovigilance specialists from around the world whose expertise and experiences is in line with the specific needs of our clients.
Analyda’s pharmacovigilance services include:
- Customized Virtual Safety
- Adverse Event Data Collection & Management
- Safety Reporting
- Safety Signal Detection
- Medical Monitoring
- Data Management
- Adverse Event Coding
Analyda recognizes the special needs of small and medium sized pharmaceutical, biotech, and medical device companies. Our clients require regulatory- compliant global safety support, but also cost-effective solutions that are free of compromising quality.
Customized Virtual Safety
Our state of the art “virtual safety department” utilizes modern and secure cloud based technologies while working with only highly experienced pharmacovigilance experts.
Analyda will help design, plan, execute, control and monitor all aspects of a medical product safety department.
Adverse Event Data Collection & Management
We provide innovative medical product safety and pharmacovigilance solutions for our customers. Using our expertise, we work hand in hand with our clients to plan, and design an infrastructure to collect, analyze, and manage data on our clients’ behalf.
In pharmacovigilance, a comprehensive safety management plan (SMP), consistent communication, regular monitoring of the processes and utilization of a robust quality management system is vital. Our safety managers are experienced in SMP development, management and ensuring a compliant and efficient safety program.
We leverage today’s innovation, to ensures that patient safety is our hallmark.
Safety Reporting
Safety Signal Detection
Analyda offers Comprehensive Pro-Active Safety Surveillance. We consult and help clients create the right customized safety signal detection program for their companies. Strategic advice may include:
- Review of current drug safety & pharmacovigilance practices
- Provide Signal Detection training for in-house staff
- Conduct Pharmacovigilance audits
- Consultation on selection of best safety databases and signal detection tools
- Consultation on Risk Management Plans and Risk Evaluation Mitigation Strategies (REMS)
- Advise on Standard Operating Procedures (SOPs) for global signal detection
- Creation of in-house Signaling and Safety Evaluation Committees
- Creation of external Drug Safety Monitoring Committees
- Review and assistance with Safety Data Exchange Agreements (SDEA)