Pharmacovigilance Excellence
In the realm of increasingly stringent safety regulations and their periodic revisions, safety data collection, analysis, and regulatory vigilance have surged, accompanied by escalating costs. Consequently, Pharmacovigilance has evolved into a pivotal phase within clinical development programs.
Our Pharmacovigilance Services stand as your assurance of regulatory compliance, efficiency enhancement, and significant cost reduction. Operating within a partnership model, our CRO service in the US delivers a wealth of benefits, leveraging our domain expertise, quality-driven systems, multidisciplinary safety proficiency, and unwavering adherence to reporting timelines dictated by entities like EMEA, FDA, MHRA, and other proficient authorities. At Sunsecure, we provide an encompassing spectrum of Pharmacovigilance Services, ranging from data collection, processing, medical review, safety writing, and report drafting to reporting, signal detection, and analysis.
Sunsecure Clinical Research Services Pvt Ltd ranks among the distinguished Pharmacovigilance companies in the US, offering comprehensive solutions that span all phases of clinical development and post-marketing initiatives for pharmaceutical, biotechnology, and medical device enterprises. Our Pharmacovigilance team furnishes a comprehensive array of premium services, including:
Establishment and upkeep of a global safety database
Literature searches aligned with regulatory prerequisites
Collection, evaluation, analysis, and reporting of safety information from diverse sources, encompassing spontaneous reports of adverse events linked to marketed drugs
Online coding (MedDRA, WHO DDE) of Adverse Events
Medical review of case reports
Preparation of safety narratives
Compilation and submission of Periodic Safety Update Reports (PSURs) to regulatory authorities
Preparation and submission of expedited reports to regulatory bodies
Streamlined processes with rapid turnaround times, ensuring clear and concise operations tailored to surpass client expectations.
Sunsecure Clinical Research Services Pvt Ltd stands as a beacon of excellence in the Pharmacovigilance landscape, dedicated to providing meticulous services across all aspects of drug safety, upholding regulatory standards, and achieving optimal outcomes for pharmaceutical, biotechnology, and medical device companies.
