Clinical Safety & Pharmacovigilance

At GGAC Research, safety comes first. As a full-service Contract Research Organization (CRO), we provide comprehensive Clinical Safety & Pharmacovigilance solutions to ensure the well-being of participants and compliance with global safety standards throughout the lifecycle of your product.

Our Clinical Safety & Pharmacovigilance Services Include:

Safety Management Planning: We develop and implement robust safety management plans tailored to the unique requirements of your clinical trials and therapeutic areas.
Adverse Event Monitoring and Reporting: Our experts provide 24/7 monitoring, timely assessment, and reporting of adverse events, serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs).
Safety Database Management: With state-of-the-art safety information systems, we ensure accurate and compliant collection, tracking, and analysis of safety data.
Signal Detection and Risk Assessment: Using advanced analytics, we identify potential safety signals and perform detailed risk assessments to mitigate safety concerns.
Regulatory Compliance: We ensure compliance with international pharmacovigilance regulations, including FDA, EMA, ICH guidelines, and local regulatory requirements.
Aggregate Reporting: Our team prepares detailed periodic safety update reports (PSURs), development safety update reports (DSURs), and risk management plans (RMPs) to meet regulatory expectations.
Post-Marketing Surveillance: We extend our services beyond clinical trials, monitoring real-world data to evaluate long-term product safety and efficacy.

Why Choose GGAC Research for Clinical Safety & Pharmacovigilance?

With a dedicated team of pharmacovigilance professionals, including physicians, safety officers, and regulatory specialists, GGAC Research offers unparalleled expertise in managing safety risks and ensuring compliance. Our proactive approach, cutting-edge technology, and commitment to quality make us your trusted partner for safeguarding patient safety and maintaining regulatory confidence.

Building Trust Through Safety

Safety is the foundation of successful clinical research and product development. GGAC Research ensures that your study is conducted with the highest standards of safety, integrity, and compliance, fostering trust among stakeholders and accelerating your path to market.

Partner with GGAC Research for world-class Clinical Safety & Pharmacovigilance solutions. Contact us today to learn how we can protect your trial and enhance its outcomes.