Clinical Safety & Pharmacovigilance
Our Clinical Safety & Pharmacovigilance services are designed to safeguard participants in clinical trials and ensure the ongoing safety of marketed products. With a proactive, comprehensive approach, we help you identify, assess, and mitigate risks, ensuring compliance with global regulatory standards and fostering trust in your therapies.
At Horgen Med, patient safety is at the core of everything we do. Our Clinical Safety & Pharmacovigilance services are designed to safeguard participants in clinical trials and ensure the ongoing safety of marketed products. With a proactive, comprehensive approach, we help you identify, assess, and mitigate risks, ensuring compliance with global regulatory standards and fostering trust in your therapies.
Why Partner with Horgen Med for Clinical Safety & Pharmacovigilance?
- Global Expertise, Local Insight: Our team of safety specialists and pharmacovigilance professionals brings deep knowledge of international regulations, including FDA, EMA, and ICH guidelines, ensuring compliance across all regions.
- End-to-End Solutions: From early-phase trials to post-marketing surveillance, we provide seamless safety monitoring and risk management throughout the product lifecycle.
- Proactive Risk Management: We don’t just react to safety signals—we anticipate them. Our robust processes and advanced tools enable early detection and mitigation of potential risks.
- Technology-Driven Approach: Leveraging state-of-the-art safety databases and analytics, we deliver accurate, timely, and actionable insights to support decision-making.
- Full-Service Integration: As a full-service CRO, we integrate pharmacovigilance with clinical operations, regulatory affairs, and data management, ensuring a cohesive and efficient approach to safety.
Our Clinical Safety & Pharmacovigilance Services Include:
- Safety Monitoring & Reporting: Continuous monitoring of adverse events (AEs) and serious adverse events (SAEs), with timely reporting to regulatory authorities.
- Case Processing & Management: Efficient collection, assessment, and documentation of safety data, ensuring compliance with global standards.
- Risk Management Plans (RMPs): Development and implementation of tailored RMPs to identify, characterize, and minimize risks throughout the product lifecycle.
- Periodic Safety Reports: Preparation of DSURs, PSURs, PBRERs, and other regulatory-required safety documents.
- Signal Detection & Management: Advanced analytics to detect emerging safety signals and inform risk mitigation strategies.
- Pharmacovigilance System Audits: Comprehensive audits to ensure your pharmacovigilance system meets regulatory requirements and industry best practices.
- Post-Marketing Surveillance: Ongoing safety monitoring for marketed products, including pharmacovigilance system maintenance and compliance.
- Training & Consulting: Customized training programs and consulting services to strengthen your internal safety and pharmacovigilance capabilities.
Commitment to Safety, Excellence, and Compliance
At Horgen Med, we understand that patient safety is non-negotiable. Our Clinical Safety & Pharmacovigilance services are built on a foundation of scientific rigor, regulatory expertise, and a commitment to ethical research. Whether you’re developing a groundbreaking therapy or managing a marketed product, we’re here to ensure the highest standards of safety and compliance.
Partner with Horgen Med to Protect Patients and Advance Your Research
Let us help you navigate the complexities of clinical safety and pharmacovigilance with confidence. Together, we can ensure the safety of your therapies and the success of your clinical programs.