Overview
Drug safety is a critical aspect of healthcare and pharmacovigilance plays a vital role in achieving this objective. Through systematic monitoring, analysis and reporting of adverse drug reactions, pharmacovigilance helps identify and mitigate risks associated with pharmaceutical products. This proactive approach to drug safety allows regulatory authorities and healthcare providers to make informed decisions, implement necessary precautions and ensure public safety.
At HCLTech, our focus is on enhancing drug safety through a comprehensive suite of client-based services. These services span clinical development, post-marketing activities and regulatory compliance, designed to cater to the critically unique needs of our clients.
Section CTA
Features
25+ years of experience in pharmacovigilance oversight for clinical trials and post-marketed products
25+ years of partnership experience in product safety
ICSR (individual case safety report) cases annually (with 80% in complex indications)
50+ databases implemented
100% internal, external and health authority audit compliance
150+ audits, two FDA audits with no 483s, complete HIPAA/21 CFR part 11, EU privacy compliance and more
75,000 literature review abstracts managed yearly
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